Article

Current challenges in clinical trial patient recruitment and enrollment

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Abstract

Achieving clinical trial research participant enrollment is essential to conducting a successful trial. Adequate enrollment provides a base for projected participant retention, resulting in evaluative patient data. Without sufficient patient retention from the time of study initiation to closeout, the number of remaining participants may prove to be too small a pool from which to derive conclusive proving or disproving the goal of the clinical trial sponsor. Obtaining final evaluative data is dependent on successful patient and principal investigator retention. Patients cannot be retained without an initial pool of enrolled volunteers. This initial pool of screened, then enrolled participants, depends on designing sound strategies for patient and investigator recruitment.

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... [3,4] Despite the bene ts of clinical research, many people approached to participate decline to do so because of deeply rooted myths about research. [5,6] Physician-scientists and basic/translational scientists need to work together to dispel these misconceptions so that enhanced participant enrollment can be attained, a step that is vital to conducting a successful clinical trial. [5] The philosophical underpinnings of conducting clinical trial research are centered around three basic ethical principles: Respect for Persons, Bene cence, and Justice. ...
... [5,6] Physician-scientists and basic/translational scientists need to work together to dispel these misconceptions so that enhanced participant enrollment can be attained, a step that is vital to conducting a successful clinical trial. [5] The philosophical underpinnings of conducting clinical trial research are centered around three basic ethical principles: Respect for Persons, Bene cence, and Justice. [7] Respect for Persons requires individuals to be treated as autonomous or independent agents. ...
... [15] Fear, distrust, and/or suspicions of research have proven to be substantial barriers to participation in research. [5,6,10] There is the belief among many prospective participants that entering a randomized trial will mean a loss of control because they will not be able to choose their treatment [5] or that clinical research will cause them harm [16] Others fear being treated like "guinea pigs" or distrust of the medical community due to past experiences, particularly in racial and ethnic minority populations. [5,17] Many believe signing the informed consent provides legal protection to physicians or researchers rather than study participants. ...
Article
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Background: Numerous barriers and challenges can hinder the successful enrollment and retention of study participants in clinical trials targeting minority populations. To conduct quality research, it is important to investigate these challenges, determine appropriate strategies that are evidence-based and continue seeking methods of improvement. Methods: In this paper, we report such experiences in a registered clinical trial in an underserved minority population in the Southern part of United States. This research study is a randomized doubleblind controlled clinical trial that tests the efficacy of higher-strength as compared to low-strength/standard of care folic acid to prevent fetal body and brain size reduction in pregnant women who smoke. A unique approach in this socio-behavioral, genetic-epigenetic clinical trial is that we have adopted the socio-ecological model as a functional platform to effectively achieve and maintain high participant recruitment and retention rates. Results: We highlight the barriers we have encountered in our trial and describe how we have successfully applied the socio-ecological model to overcome these obstacles. Conclusions and Global Health Implications: Our positive experience will be of utility to other researchers globally. Our findings have far-reaching implications as the socio-ecological model approach is adaptable to developed and developing regions and has the potential to increase recruitment and retention of hard-to-reach populations who are typically under-represented in clinical trials.
... 86% of clinical trials don't achieve their recruitment goals on time 3 and 19% of registered clinical trials were either closed or terminated due to failure to reach expected enrollment 4 . Barriers persist although there have been many research papers addressing the challenges of identifying and recruiting subjects to clinical trials over the past decades [5][6][7][8][9] . ...
... Barriers to recruiting patients into clinical trials can be classified into three different categories (Table 1) based on (1) sponsor perspectives, (2) principal investigator perspectives, and (3) subject perspectives 3,8 . Sponsors initially need adequate participants for the potential trial to file an application with the Food and Drug Administration (FDA) for approval 3 . ...
... Sponsors need to design clinical trial protocols such as inclusion/exclusion criteria which can be used to check the eligibility of potential subjects. Detailed protocols can drastically narrow the subject population, which increases the difficulty of recruitment 8,11 . Sponsors need to settle on trial sites without knowing the geographical distribution of future subjects 7 , but distant trial sites will deter many potential subjects 8 . ...
Article
Full-text available
Patient recruitment for clinical trials is known to be a challenging aspect of clinical research. There are multiple competing concerns from the sponsor, patient and principal investigator's perspectives resulting in most clinical trials not meeting recruitment requirements on time. Conducting under-enrolled clinical trials affects the power of conclusive results or causes premature trial termination. The Blockchain is a distributed ledger technology originally applied in the financial sector. Its features as a peer-to-peer system with publicly audited transactions, data security, and patient privacy are a good fit for the needs of clinical trials recruitment. The "Smart Contract" is a programmable self-executing protocol that regulates the blockchain transactions. Given current recruitment challenges, we have proposed a blockchain model containing multiple trial-based contracts for trial management and patient engagement and a master smart contract for automated subject matching, patient recruitment, and trial-based contracts management.
... Patient enrollment in clinical trials is a critical factor which determines the success of a clinical trial. Despite the large number of trials being conducted, only about 3% of oncology patients in the United States are enrolled in clinical trials [57]. Adequate enrollment will guarantee sufficient patient retention in the concluding stages of the trial. ...
... Adequate enrollment will guarantee sufficient patient retention in the concluding stages of the trial. Insufficient patient retention often results in a small cohort of clinical data which is very unlikely to provide any conclusive evidence regarding the efficacy of the therapy under evaluation [57]. Often, clinical trial sponsors offer monetary compensation to physicians, nurses and medical personnel to recruit patients [58]. ...
... Such a practice may result in the recruitment of patients unsuitable for the trial thereby greatly increasing the patient drop-out rates during the course of the trial. Lack of knowledge of ongoing clinical trials, public misconceptions of clinical trials, hesitation of under-represented populations to enroll in trials, possibility of incurring costs not covered by insurance, administrative formalities associated with enrollment in clinical trials are some of the factors that discourage patient enrollment [57,59,60,61]. Although, the co-clinical and mouse avatar paradigm aim to address some of the scientific challenges facing clinical trials today -the social aspect remains largely unaddressed. ...
Article
Over the last few decades, study of cancer in mouse models has gained popularity. Sophisticated genetic manipulation technologies and commercialization of these murine systems have made it possible to generate mice to study human disease. Given the large socio-economic burden of cancer, both on academic research and the health care industry, there is a need for in vivo animal cancer models that can provide a rationale that is translatable to the clinic. Such a bench-to-bedside transition will facilitate a long term robust strategy that is economically feasible and clinically effective to manage cancer. The major hurdles in considering mouse models as a translational platform are the lack of tumor heterogeneity and genetic diversity, which are a hallmark of human cancers. The present review, while critical of these pitfalls, discusses two newly emerging concepts of personalized mouse models called "Mouse Avatars" and Co-clinical Trials. Development of "Mouse Avatars" entails implantation of patient tumor samples in mice for subsequent use in drug efficacy studies. These avatars allow for each patient to have their own tumor growing in an in vivo system, thereby allowing the identification of a personalized therapeutic regimen, eliminating the cost and toxicity associated with non-targeted chemotherapeutic measures. In Co-clinical Trials, genetically engineered mouse models (GEMMs) are used to guide therapy in an ongoing human patient trial. Murine and patient trials are conducted concurrently, and information obtained from the murine system is applied towards future clinical management of the patient's tumor. The concurrent trials allow for a real-time integration of the murine and human tumor data. In combination with several molecular profiling techniques, the "Mouse Avatar" and Co-clinical Trial concepts have the potential to revolutionize the drug development and health care process. The present review outlines the current status, challenges and the future potential of these two new in vivo approaches in the field of personalized oncology.
... Knowledge can be an important factor in clinical trial participation for several reasons. First, low levels of factual knowledge about trial procedures (e.g., random assignment, informed consent) may impede participation (Frank, 2004). Second, patients are often reluctant to participate in something they do not know much about (Jones et al., 2006). ...
... Misperceptions about clinical trials may also impede participation. Although studies (e.g., Stiller, 1994) have reported that entry into clinical trials is frequently associated with a higher survival rate, there exists a misperception that standard therapy is the best and that investigational treatments are not as effective (Frank, 2004;Harris Interactive, 2001). There is also a typical misperception that patients in clinical trials are treated like guinea pigs (Friedman, Bergeron, Foster, Tanner, & Kim, 2013;Owens, Jackson, Thomas, Friedman, & Hebert, 2013). ...
... Long-lasting distrust exists among African Americans. The abuses in the past (e.g., the Tuskegee syphilis study), combined with perceived discrimination, indifference, and disrespect, may have all contributed to distrust of medical care and research among African Americans (Frank, 2004). ...
Article
Full-text available
Analyzing data from a survey of African American and White residents in South Carolina, this study attempts to understand how to better promote clinical trial participation specifically within the African American population. To explore why participation is lower in the African American population, the authors examined two sets of potential barriers: structural/procedural (limited accessibility, lack of awareness, doctors not discussing clinical trial options, lack of health insurance) and cognitive/psychological (lack of subjective and factual knowledge, misperceptions, distrust, fear, perceived risk). Findings revealed that African Americans were significantly less willing than Whites to participate in a clinical trial. African Americans also had lower subjective and factual knowledge about clinical trials and perceived greater risk involved in participating in a clinical trial. The authors found that lack of subjective knowledge and perceived risk were significant predictors of African Americans' willingness to participate in a clinical trial. Implications of the findings are discussed in detail.
... 35). Overall, African Americans tend to have a general lack of trust in doctors and the medical/scientific community (Frank, 2004) and have fear and misperceptions about medical research (Branson et al., 2007). Fear of being used as research guinea pigs has been expressed among many African Americans (Frank, 2004). ...
... Overall, African Americans tend to have a general lack of trust in doctors and the medical/scientific community (Frank, 2004) and have fear and misperceptions about medical research (Branson et al., 2007). Fear of being used as research guinea pigs has been expressed among many African Americans (Frank, 2004). This can contribute to the general fear of a "loss of control" that many individuals experience when thinking about entering into a randomized trial (Frank, 2004). ...
... Fear of being used as research guinea pigs has been expressed among many African Americans (Frank, 2004). This can contribute to the general fear of a "loss of control" that many individuals experience when thinking about entering into a randomized trial (Frank, 2004). And, there is a strong need to build medical trust with minorities (Coakley et al., 2012;Otado et al., 2015). ...
Article
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The current study was designed to examine effective message strategies that can be employed in designing mediated communication messages to improve clinical trial research participation. In the study, a total of 300 participants completed an online experiment in which they responded to five different clinical trial recruitment advertisements whose information sources varied in their credentials and race. Overall, peer-featured ads in which previous clinical trial participants communicated their prior experience in clinical trial participation, compared to expert-featured ads in which medical doctors communicated information about clinical trials, led to higher message and topic relevance, higher message credibility, more favorable attitudes toward clinical trials, and higher intentions to participate in future clinical trials. Further, there was a statistically significant interaction among source credentials, racial match (between source and participant), and participant’s race on message and topic relevance such that both White and Black participants rated ads from racially mismatched peers highly effective (greater message and topic relevance); however, for doctor featured ads, White participants reported higher message and topic relevance for racially matched (White doctor) ads, and Black participants reported higher message and topic relevance for racially mismatched (White doctor) ads. We discuss theoretical and practical implications.
... G. Ford et al., 2005;M. E. Ford et al., 2003;Frank, 2004;D. B. Friedman, Corwin, Rose, & Dominick, 2009;Langford, Resnicow, & An, 2010;Moinpour et al., 2000;Pinto, McCaskill-Stevens, Wolfe, & Marcus, 2000;Sateren et al., 2002;Shavers, Lynch, & Burmeister, 2002). ...
... Beyond being clinically disqualified, potential CT participants are excluded from CTs for a number of structural and procedural reasons, including the extra time and effort required for participating in trials (Comis et al., 2003), lack of insurance or insurance denial (Brown et al., 2000;Brown & Topcu, 2003;Comis et al., 2003) and medical providers who are reluctant to engage in, or are unaware of, ongoing trials (Comis et al., 2003;Frank, 2004). ...
... Psychological barriers to CT participation include misperceptions, distrust, and fear. There are misperceptions that standard therapy is the best and that CT patients are treated like guinea pigs (Frank, 2004). Equally typical is the perception that patients agree to participate only if their condition is terminal (Quinn et al., 2007). ...
Article
Full-text available
Clinical trials help advance public health and medical research on prevention, diagnosis, screening, treatment, and quality of life. Despite the need for access to quality care in medically underserved areas, clinical trial participation remains low among individuals in rural and African American communities. This study assessed clinical trial research in South Carolina's five main academic medical centers, focusing specifically on clinical trial investigators' perceived barriers to recruitment in the general population and in rural and African American communities. Online survey responses (N = 119) revealed that it was most difficult for investigators to recruit from rural areas and that rural residents were least likely to be represented in medical research, behind both the general public and African Americans. Barriers focusing on communication or awareness proved to be the biggest hurdles to finding potential participants in both the general public and rural communities. Psychological barriers to recruitment were perceived to be most prevalent in African American communities. Study findings provide important insights from the perspective of the clinical trial investigator that will aid in the development of effective communication and education strategies for reaching rural and African American residents with information about clinical trials.
... Knowledge can be an important factor in participation for several reasons. First, low levels of knowledge or confusion about the key facts of trial procedures (e.g., random assignment, informed consent, or standard treatments) can impede participation [17]. Second, patients are often reluctant to participate in something they do not know much about [9]. ...
... Misperceptions about CTs may also impede participation. Although studies [18] have reported that entry into CTs is frequently associated with a higher survival rate, there exists a misperception that standard therapy is the best and that investigational treatments are not as effective [17]. There is also a typical misperception that patients in CTs are treated like ''guinea pigs'' [19]. ...
... It is also important to point out that long-lasting distrust and fear exist among minority members of rural populations. The abuses in the past (e.g., the Tuskegee syphilis study), combined with perceived discrimination, indifference, and disrespect, may all contribute to the distrust and fear of the medical care system, particularly among rural minority populations [17]. ...
Article
Full-text available
Analyzing data from a telephone survey of rural and urban residents in South Carolina, this study attempts to understand how to better promote clinical trials (CTs) in rural areas. To explore why participation is lower among the rural population, we examine two groups of potential barriers: structural and procedural barriers (limited accessibility, lack of awareness, lack of health insurance) and cognitive and psychological barriers (lack of knowledge, misperceptions, distrust, fear). We then make a series of comparisons between rural and urban residents to see whether rural residents are significantly different from urban residents in terms of structural/procedural and cognitive/psychological barriers they are facing. Findings indicate that there are no significant differences between rural and urban residents in their willingness to participate in a CT. However, rural residents were more likely to perceive limited access to CT sites and lack of awareness of available trials. Rural residents also indicated greater lack of knowledge about CTs. Finally, we found that distrust and fear were important barriers in shaping one's willingness to participate in a CT. Implications of the findings are discussed in detail.
... 86% of clinical trials don't achieve their recruitment goals on time 3 and 19% of registered clinical trials were either closed or terminated due to failure to reach expected enrollment 4 . Barriers persist although there have been many research papers addressing the challenges of identifying and recruiting subjects to clinical trials over the past decades [5][6][7][8][9] . ...
... Barriers to recruiting patients into clinical trials can be classified into three different categories (Table 1) based on (1) sponsor perspectives, (2) principal investigator perspectives, and (3) subject perspectives 3,8 . Sponsors initially need adequate participants for the potential trial to file an application with the Food and Drug Administration (FDA) for approval 3 . ...
... Sponsors need to design clinical trial protocols such as inclusion/exclusion criteria which can be used to check the eligibility of potential subjects. Detailed protocols can drastically narrow the subject population, which increases the difficulty of recruitment 8,11 . Sponsors need to settle on trial sites without knowing the geographical distribution of future subjects 7 , but distant trial sites will deter many potential subjects 8 . ...
Conference Paper
Full-text available
Patient recruitment for clinical trials is known to be a challenging aspect of clinical research. There are multiple competing concerns from the sponsor, patient and principal investigator's perspectives resulting in most clinical trials not meeting recruitment requirements on time. Conducting under-enrolled clinical trials affects the power of conclusive results or causes premature trial termination. The Blockchain is a distributed ledger technology originally applied in the financial sector. Its features as a peer-to-peer system with publicly audited transactions, data security, and patient privacy are a good fit for the needs of clinical trials recruitment. The "Smart Contract" is a programmable self-executing protocol that regulates the blockchain transactions. Given current recruitment challenges, we have proposed a blockchain model containing multiple trial-based contracts for trial management and patient engagement and a master smart contract for automated subject matching, patient recruitment, and trial-based contracts management.
... Previous studies have tried to identify potential contributors to recruitment rates of study participant such as 'opt-out' approaches [20], early consideration of participants' perspectives [21], addressing ethical issues such as the therapeutic misconception [6], and establishing trust between researchers and potential participants [22]. The recruitment rate, however, may have been affected by other factors beyond the consent information as the complexities of the challenges of recruitment are also determined by the complexities of the respective studies [7,23,24] and decisions being made prior to recruitment based on information circulating in the community [25]. ...
... Recruitment rate has been documented as an important determinant of subsequent retention [6,24]. Other factors affecting retention include mental state of the person [26], availability of tracking and follow-up mechanisms [27], availability of mechanisms addressing community and context-specific issues and needs in special communities [28]. ...
Article
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Background: Maximizing comprehension is a major challenge for informed consent processes in low-literacy and resource-limited settings. Application of rapid qualitative assessments to improve the informed consent process is increasingly considered useful. This study assessed the effects of Rapid Ethical Assessment (REA) on comprehension, retention and quality of the informed consent process. Methods: A cluster randomized trial was conducted among participants of HPV sero-prevalence study in two districts of Northern Ethiopia, in 2013. A total of 300 study participants, 150 in the intervention and 150 in the control group, were included in the study. For the intervention group, the informed consent process was designed with further revisions based on REA findings. Informed consent comprehension levels and quality of the consent process were measured using the Modular Informed Consent Comprehension Assessment (MICCA) and Quality of Informed Consent (QuIC) process assessment tools, respectively. Result: Study recruitment rates were 88.7 % and 80.7 % (p = 0.05), while study retention rates were 85.7 % and 70.3 % (p < 0.005) for the intervention and control groups respectively. Overall, the mean informed consent comprehension scores for the intervention and control groups were 73.1 % and 45.2 %, respectively, with a mean difference in comprehension score of 27.9 % (95 % CI 24.0 % - 33.4 %; p < 0.001,). Mean scores for quality of informed consent for the intervention and control groups were 89.1 % and 78.5 %, respectively, with a mean difference of 10.5 % (95 % CI 6.8 -14.2 %; p < 0.001). Conclusion: Levels of informed consent comprehension, quality of the consent process, study recruitment and retention rates were significantly improved in the intervention group. We recommend REA as a potential modality to improve informed consent comprehension and quality of informed consent process in low resource settings.
... The intricate nature of managing care in CKD patients may also result in some physicians neglecting to refer their patients to research studies as a result of not wanting to give up control of their complex care regimens. (8) This may be especially true in the case of CKD patients since they are often taking a plethora of medications for their various comorbidities and altering these medications can require careful titration. ...
... Unfortunately, distrust and suspicions about research have been perpetuated by the media as the public is often given information regarding accidental exposures of patient information. (8) The general public is likely to remember those cases and never be made aware that the vast majority of research studies are conducted up to high ethical standards. ...
Article
Despite rates of CKD continuing to increase, the current evidence base used to guide CKD management is smaller than that for many other chronic diseases. Clinical investigators face multiple barriers to conducting research in patients with CKD. CKD patients have multiple comorbidities that make them a risky intervention target; thus, they are often excluded from trials. The lack of approved surrogate endpoints for kidney disease progression makes testing therapies to slow progression very challenging and expensive. Patients with CKD have higher rates of disability and lower educational status than the general population, which further complicates their participation in clinical trials. Despite these barriers, it is imperative that scientific progress be made in this patient population. Increasing education and information regarding CKD clinical trials through brochures and public awareness campaigns may increase trial participation. The U.S. Food and Drug Administration needs to approve the new definition of glomerular filtration rate decline because this will result in a decrease in the cost of clinical trials and make industry more likely to invest in trials in patients with CKD. Successful research in this patient population is possible, but it requires collaboration among investigators, health-care providers, patients, industry, and the National Institutes of Health.
... Previous studies have tried to identify potential contributors to recruitment rates of study participant such as 'optout' approaches (57), early consideration of participants' perspectives (58), addressing ethical issues such as the therapeutic misconception (55), and establishing trust between researchers and potential participants (59). Recruitment rate is considered to be a determinant of subsequent retention (55,60). ...
... However every study has its own peculiar features and it may be difficult to generalise these factors. The complexities of the challenges of recruitment are also determined by the complexities of the respective studies (56,60,64). The registered improvement in the study retention rate in our study may have resulted from improved understanding of the consent information. ...
Book
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Informed consent is a key component of biomedical research involving human participants. However, obtaining informed consent is challenging in low literacy and resource limited settings. Potential research participants should be assisted with interventions to improve their comprehension. Application of Rapid Ethical Assessments(REA) is an intervention developed to contextualize consent processes in low-income setting. The current study showed that comprehension and quality of informed consent were improved through locally and contextually tailoring the informed consent information and consent process to the study area based on the rapid ethical assessment findings. This implies that potential study participant in a research can be assisted to comprehend consent components, and subsequently comply with further tasks to be performed. Therefore, it is recommended that rapid ethical assessment to be further used to address gaps on comprehension and quality of informed consent process.
... Previous studies have tried to identify potential contributors to recruitment rates of study participant such as 'optout' approaches (57), early consideration of participants' perspectives (58), addressing ethical issues such as the therapeutic misconception (55), and establishing trust between researchers and potential participants (59). Recruitment rate is considered to be a determinant of subsequent retention (55,60). ...
... However every study has its own peculiar features and it may be difficult to generalise these factors. The complexities of the challenges of recruitment are also determined by the complexities of the respective studies (56,60,64). The registered improvement in the study retention rate in our study may have resulted from improved understanding of the consent information. ...
... In the USA, people living in rural areas report poorer health status than urban residents [1][2][3][4][5] . This health disparity is often linked to rural residents' lack of access to healthcare services, shortages of healthcare professionals, lower rates of health insurance, problems working with third-party payers, and low socioeconomic and educational status [6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21] . For example, individuals living in rural areas experience a higher prevalence of chronic diseases such as obesity, heart disease, cancer, and diabetes than people in urban areas 2,21-26 . ...
... The survey instrument was composed of 33 items, which were developed based on extensive literature on CT participation 6,8,9,12,36,43,46,47 . The survey instrument included a combination of open-and closed-ended questions to gather information about the volume and scope of CT research taking place at South Carolina's main academic medical centers, the extent to which rural residents in South Carolina are represented in clinical research, and PIs' perceptions of barriers to CT recruitment. ...
Article
Full-text available
Participation in clinical trial (CT) research can help decrease health disparities in rural communities. The purpose of this study was to examine the perceptions of principal investigators (PIs) regarding CT participation barriers and recruitment efforts in rural South Carolina, USA and to assess the actual pool of potential CT participants in rural and urban South Carolina. The ultimate goal was to evaluate the fit between PIs' perceptions and the pool of eligible participants in rural South Carolina. An online survey was conducted with 119 CT PIs from South Carolina's five main academic medical centers located in urban areas of the state, for a response rate of 31%. Secondary data analyses were also conducted using data from government health insurance plans, including the 2009 South Carolina Medicaid, the 2009 State Health Plan (SHP) data, and census data from the 2005-2009 American Community Survey (ACS). Both parametric and non-parametric statistics were used to analyze survey and secondary data. Principal investigators perceived greater recruitment barriers in rural areas than in the general population. They indicated having difficulty finding CT participants in rural areas compared to the general population ( t =-2.985, p =0.004). Rural residents were significantly more likely to be perceived as lacking knowledge and understanding about CT than the general public ( t =-2.105, p =0.038), having significantly lower literacy than the general public ( t =-2.058, p =0.043), lacking information about available CTs ( t =-2.913, p =0.005), and having limited accessibility to trial sites compared to the general population ( t =-4.380, p =0.000). Patients' insurance coverage, however, was not found to be a significant barrier for CT participation (t =0.418, p =0.677). Secondary data variables were aligned with these barriers. Data revealed that rural residents have slightly lower educational attainment than urban citizens ( t =5.384, p =0.000), and more people live below poverty level in rural areas (23%) than in urban areas (15%) ( t =4.86, p =0.000). The secondary data analyses also showed that the majority of rural citizens covered by the SHP and Medicaid are eligible for CTs. ACS data revealed that 75% of people in rural areas meet one or more basic eligibility requirements to participate in CTs compared to 83% in urban areas. Some important barriers hinder CT enrollment of rural participants, such as accessibility to trial sites, poverty, lack of knowledge about CTs, among others. Data suggested that insurance coverage, however, is not a barrier to CT participation. Although CT PIs are correct in considering these barriers in rural areas, there still exists a large pool of potentially eligible CT participants in rural South Carolina. PIs, who were recruited from urban academic medical centers, may therefore be perpetuating unhelpful rural myths about CT eligibility in rural communities. Despite their remote locations, rural citizens should take part in medical research. Greater communication between PIs and rural participants and better education of PIs on communication strategies are needed to enhance CT participation in rural South Carolina.
... 16 Likewise, Grunfeld et al, Frank, and Caulfield have identified some barriers to patient enrolment from a pharmaceutical industry perspective, such as recruitment costs, recruitment strategy and complex protocols concerning inclusion and exclusion criteria. [17][18][19] To further explore the barriers to patient enrolment in phase III cancer clinical trials and by such improve pertinent recruitment practice, our aim was to explore these barriers from the perspectives of principal investigators (PIs), clinicians and pharmaceutical representatives. ...
... 20 This research design provided us with the means to examine the topic more in-depth than a quantitative study would have allowed. 21 22 Existing knowledge of patient enrolment barriers to clinical trials as perceived by clinicians and the pharmaceutical industry (online supplemental appendix 2) [17][18][19] was used to develop a conceptual framework to guide our interviews. After completing the questionnaire and the interview guide, we tested the questionnaire on one PI, to check for clarity and internal validity. ...
Article
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Objectives Phase III cancer clinical trials are expensive and time-consuming phases in drug development. Effective patient enrolment can reduce delays and save costs, offering patients an opportunity to benefit from innovative treatments. However, the current evidence base does not fully explain the persistence of barriers to patient enrolment in phase III cancer clinical trials. The aim was to explore clinicians’ and pharmaceutical representatives’ views on these barriers. Design A qualitative study was performed. In-depth information was collected from 15 experts in the field of oncology clinical trials, in particular clinical oncologists acting as principal investigators (PIs) and clinical research associates. By means of semistructured interviews, based on a questionnaire derived from our newly developed conceptual framework, they were asked to identify barriers to patient enrolment they had experienced and comment on barriers identified in literature. Findings Existing knowledge on barriers to patient enrolment was confirmed by all interviewees. Two new key barriers to patient enrolment were identified, that is, insufficient attention to the importance of clinical trial-based research in medical training and a trust gap between PIs and pharmaceutical representatives. A third important barrier was increasingly narrow patient inclusion criteria. Conclusions The success rate of patient enrolment in phase III cancer clinical trials highly depends on the clinicians’ willingness to take part in clinical trials. Raising awareness of the importance of clinical trials in medical training and among practising oncologists is recommended. Furthermore, to reduce barriers to patient enrolment, it is essential that both clinicians and pharmaceutical representatives acknowledge each other’s expertise, become acquainted with each other’s procedures and regulations, and work on building trust relationships. Finally, in accordance with our key findings, we propose to add two new barriers to our newly developed conceptual framework; insufficient attention to clinical trial research in medical training and trust gap.
... For various reasons, knowledge can be a major factor in participation. First, low knowledge or confusion about the key facts of trial methods (random allocation, informed consent, standard treatment) can disrupt participation (46). Secondly, patients are often reluctant to participate in something about which they have little knowledge (47). ...
... das Argument weiter oben und Katz et al. 2008), während man sich uneinig darüber ist, warum Frauen insgesamt seltener an klinischen Studien teilnehmen, sofern sie nicht explizit ausgeschlossen werden. Zudem könnten eine schlechte Informationspolitik oder ein Bias auf Seiten der Studienleiter weitere Hindernisse darstellen (Frank 2004). Um den Anspruch auf gerechtere deskriptive Repräsentation von Frauen und Schwarzen sowie insbesondere von Schwarzen Frauen aus intersektionaler Perspektive besser einordnen zu können, muss genauer auf den Umgang mit biologischer Differenz als biomedizinpolitischem Problem eingegangen werden -auch hier hilft ein analytischer Blick in die Geschichte. ...
... [11] This may be because of patriarchal system in India where women are given less importance or because of women themselves do not give importance to their health. The result of this study is supported by Genevieve Frank [12] which mentions that women distrust medical research and thus participation in trials is more limited. ...
Article
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Introduction: Rheumatoid arthritis (RA) affects 0.5-1% of population all over the world. As the duration of treatment is more in RA, patient's adherence to treatment is less. Controlling the number of patients lost to follow-up is essential for the successful completion of randomized clinical trials. Also, patient adherence is critical in clinical trial setting as it has impact on validity of clinical data and also it remains an issue of utmost importance to pharmaceutical manufacturers as well as scientific and regulatory community. The studies which show reasons for withdrawal from clinical trials are done for diseases like tuberculosis (TB). None of the study is available to find reasons for withdrawal from clinical trials in RA. Hence, this study is planned. Aims and Objectives: Find reasons and effect of age, sex, duration of therapy, and distance from home on withdrawal from clinical trial. Materials and Methods: This study is a retrospective observational data analysis. Primary outcome are to find reasons for withdrawal from trial. Results: Withdrawal from clinical trial in patients of RA is more in female. In this study, reasons for withdrawal from study are change in location, loss to follow-up, failure of therapy, concomitant illness, patient withdrew consent, and adverse effects is the common reason for withdrawal from clinical trial in both patient and investigator-related reason for withdrawal.
... People with a particular medical problem should have more information about relevant clinical trials to improve their likelihood of taking part in these trials. [18][19][20] Potential study subjects would know which clinical trials were being conducted and where they could go to enroll and participate in the studies. ClinicalTrials.gov ...
Article
Background: This study uses the data from many of the mandatory fields in ClinicalTrials.gov to examine changes, possibly leading to more complexity in the design and execution of commercially sponsored phase 3 clinical trials. Methods: In this analysis we compare baseline year 2008 data, when a broad number of the protocol/study design and execution variables became mandatory, with the data from the last full year of results, 2013. Results: There has been relatively little change in the protocol and study design over the years covered in this study. The most pronounced change is associated with single-patient duration: there is a significant increase in the period of time a patient is treated in the study protocol. The study also highlights an important methodological issue: many of the claims in print about complexity have yet been substantiated through the use of peer-reviewed data or in settings where others can interrogate the results. Conclusions: In general, there is limited evidence for significant increases in the study and protocol design and execution of phase 3 clinical trials sponsored by pharmaceutical companies.
... Participant enrolment for clinical trials is a central management function which has greater impact on the cost and time taken for the development of a medical device [17]. Also, for a successful conduction of clinical trials, achieving adequate participant enrolment rate is a major challenge [7]. For speeding up the medical device development process, selecting qualified clinical trial locations which recruit appropriate participants becomes very attractive to sponsors [2]. ...
Conference Paper
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Unmet clinical needs remain the primary driving force for innovations in medical devices. While appropriate mechanisms to protect these innovative outcomes are essential, the performance of clinical trials to ensure safety is also mandated before the invention is ready for public use. Literature explaining the relationship between patenting activities and clinical trials of medical devices is scarce. Linking patent ownership to clinical trials may imply product leadership and value chain control. In this paper, we use patent data from Indian Patent Office (IPO), PCT, and data from Clinical Trials Registry of India (CTRI) to identify whether patent assignees have any role in leading as primary sponsors of clinical trials. A total of 42 primary sponsors are identified from the CTRI database in India. Number of patents awarded to these primary sponsors in the particular medical device, total number of patents awarded to the primary sponsor in all technologies, total number of patents in the specific medical device technology provides an indication of leadership and control in the value chain.
... Professional research participants have developed their own social networks, web pages, associations, and publications, which they use to learn about new studies, share information and experiences, and understand the ethical, regulatory, and scientific aspects of clinical research. 11 Ninety percent of repeat volunteers listed financial reward as a primary motivation to enroll in clinical trials. 12 Other reported motivations include the altruistic benefit to society, accessing ancillary health care benefits, scientific interest or interest in the goals of the study, and curiosity. ...
Article
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The transition of new biotechnologies into clinical trials is a critical step in approving a new drug or therapy in health care. Ethically recruiting appropriate volunteers for these clinical trials can be a challenging task for both the pharmaceutical companies and the US Food and Drug Administration. In this paper we analyze the Jewish halachic perspectives of volunteering for clinical trials by focusing on an innovative technology in reproductive medicine, mitochondrial replacement therapy. The halachic perspective encourages individuals to volunteer for such clinical trials under the ethical principles of beneficence and social responsibility, when animal studies have shown that health risks are minimal.
... We also found participants with excellent and very good health status reported greater research participation; however, this was only found among White men reporting participation in any and behavioral research. Although insurance coverage has been reported as a barrier to clinical trial participation in cancer [26], Latino men in our study with public/government/no insurance were more likely to report participation in any and behavioral research. A research study that oversamples Latino men, based in California and linked to a state-funded treatment program for uninsured men with PCa since 2006 [27,28], may have contributed to our finding. ...
Article
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Purpose We examined prostate cancer patients’ participation in research and associated factors by race/ethnicity in a multiethnic sample. Methods Men with a new diagnosis of prostate cancer were identified through the California Cancer Registry. Patients completed a cross-sectional telephone interview in English, Spanish, Cantonese or Mandarin. Multivariable logistic regression models, stratified by race/ethnicity, estimated the associations of patient demographic and health characteristics with participation in (1) any research, (2) behavioral research, and (3) biological/clinical research. Results We included 855 prostate cancer patients: African American (19%), Asian American (15%), Latino (24%), and White (42%). In the overall model of participation in any research, African American men (Odds Ratio (OR) = 2.54, 95% CI 1.63–3.94), and those with two or more comorbidities (OR = 2.20, 95% CI 1.27–3.80) were more likely to report participation. Men 65 years old and older (OR = 0.65, 95% CI 0.47–0.91), those who were married or living with a partner (OR = 0.67, 95% CI 0.45–0.98), and those who completed the interview in Spanish (OR = 0.36, 95% CI 0.15–0.85) were less likely to report participating in any research. Stratified analyses identified racial/ethnic-specific sociodemographic characteristics associated with lower research participation, including Spanish or Chinese language, older age, and lower education. Conclusion African American prostate cancer patients reported higher research participation than all other groups. However, recruitment efforts are still needed to overcome barriers to participation for Spanish and Chinese speakers, and barriers among older adults and those with lower education levels.
... There are different forms of CT knowledge that facilitate participation, such as awareness of available CTs (Langford et al., 2010) and knowledge about the need for and benefits of CTs (Ejiogu et al., 2011). This study focuses on factual knowledge about CT procedures, as understanding of the process of CTs plays an important role in CT participation (Frank, 2004). Knowledge about CT procedures can encourage participation by alleviating uncertainties and concerns about the process and helping participants become more confident about exactly what they are participating in (Tanner et al., 2014). ...
Article
This study aims to (a) examine the roles of knowledge, distrust in medical professionals, information sources, and 2 dimensions of religiosity (i.e., religious activity and religious belief) in influencing willingness to participate (WTP) in cancer clinical trials and to (b) compare the results for Caucasians and African Americans in order to inform future recruitment. An online survey was fielded via a Knowledge Networks panel with a nationally representative sample including 478 Caucasians and 173 African Americans. The results showed that distrust in medical professionals was a strong barrier to WTP for both ethnic groups, whereas factual knowledge about trial procedures was not associated with WTP for either ethnic group. Seeking trial information from doctors was positively associated with WTP for Caucasians; seeking trial information from hospitals was positively associated with WTP for African Americans. More interestingly, levels of religious activity negatively predicted WTP for Caucasians but positively predicted WTP for African Americans. Self-reported religious belief was not associated with WTP for either ethnic group. In sum, although distrust is a common barrier to WTP, the influence of preferred information sources and religious activity on WTP varies as a function of ethnicity.
... Despite these facts, importance of subject recruitment often remains underestimated, and institutional resources are rarely deployed to facilitate subject recruitment. [2][3][4] Since poor recruitment is a crucial factor in conduct of RCTs, it is essential to investigate the barriers to recruitment and devise potential strategies to improve the same in clinical trials. Several international studies investigating the issues in recruitment have put forth strategies such as piloting the recruitment process, financial and educational incentives for clinicians, newsletter and reminders for patients, open-versus placebo-controlled trials, assistance with patient travel, and networking with various healthcare professionals. ...
Article
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Background: Successful recruitment of patients is known to be one of the most challenging aspects in conduct of randomized controlled trials. Inadequate patient retention during conduct of trial affects conclusive results. Objective: To assess the level of challenges faced by Indian investigators in recruitment and retention of trial subjects. Methods: We developed a survey questionnaire on challenges encountered by investigators in subject recruitment and retention which was hosted on a web portal. Results: Seventy-three investigators from India participated in the survey. The frequently encountered challenges in subject recruitment were complexity of study protocol (38%), lack of awareness about clinical trials in patients (37%), and sociocultural issues related to trial participation (37%). About 63% of participants strongly agreed that creating a positive awareness about clinical trials among people through press and media, having a dedicated clinical research coordinator for trial (50.7%), and designing a recruitment strategy prior to study initiation (46.6%) would enhance recruitment. Almost 50.7% of participants agreed that interacting with medical community in vicinity of the study site and educating patients about clinical trials during routine outpatient department visits (46.6%) would enhance recruitment. Experiencing a serious adverse event, subject's fear for study procedures (47%) and side effects (44%) were thought to have a moderate effect on subject retention. Conclusion: Our survey has put forth factors related to negative publicity by media, lack of patient education about clinical trials; complex study designs are barriers to clinical trial recruitment in India. It is essential to devise innovative and effective strategies focusing on education of public and mass media about clinical research in India.
... 11 However, patient recruitment is a challenging and pressing issue for researchers as it has several barriers, including the lack of patient awareness of clinical trials and access to trials, age limitations, complex study designs, fewer eligible patients than expected due to restrictive eligibility criteria and several other reasons. 12,13,14 An analysis of registered trials showed that approximately 85% of trials were not able to complete required recruitment in the pre-defined time and around 20% of the trials were closed or terminated early due to inadequate patient recruitment, 15 limiting the statistical power of the evidence related to the new interventions. 16 Moreover, more than 70% of clinical trial generalizability assessment studies reported low generalizability of completed trials, partly due to low enrollment. ...
Article
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Dietary supplements (DSs) have been widely used in the U.S. and evaluated in clinical trials as potential interventions for various diseases. However, many clinical trials face challenges in recruiting enough eligible patients in a timely fashion, causing delays or even early termination. Using electronic health records to find eligible patients who meet clinical trial eligibility criteria has been shown as a promising way to assess recruitment feasibility and accelerate the recruitment process. In this study, we analyzed the eligibility criteria of 100 randomly selected DS clinical trials and identified both computable and non-computable criteria. We mapped annotated entities to OMOP Common Data Model (CDM) with novel entities (e.g., DS). We also evaluated a deep learning model (Bi-LSTM-CRF) for extracting these entities on CLAMP platform, with an average F1 measure of 0.601. This study shows the feasibility of automatic parsing of the eligibility criteria following OMOP CDM for future cohort identification.
... Many patients harbor misconceptions about trials; in a survey of nearly 6,000 patients, 37% thought their medical care would be better if they did not enroll in a trial, and 22% believed enrolling in a clinical trial would lead to them being "treated like a guinea pig" [9]. Such fears are not completely unfounded given that that participating in a trial is increasingly burdensome, with the median number of study procedures that patients must endure rising from 20 per protocol in 2000-2003 to 30 in 2008-2011 [10]. ...
Article
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Background Developing new medicines relies on the successful conduct of clinical trials. As trial protocols become more arduous, it becomes harder to recruit and retain patient volunteers, although recent efforts such as OMERACT and I-SPY2 show that partnering with patients can be beneficial. We sought to describe drivers and barriers to trial participation, as well as condition-specific trial preferences. Methods An online survey was fielded via the patient-powered research network PatientsLikeMe to 1,621 members living with nine selected chronic health conditions. Questions included demographics, trial experience, reasons for non-participation, questions relating to aspects of trial design, and an adaptation of the Net Promoter Score (NPS) for trial satisfaction. ResultsMean age of respondents was 55 years; most patients were white (93%), female (67%), and living in the United States (72%). Primary conditions were MS (21%), Parkinson’s (20%), fibromyalgia (15%), ALS (10%), type 2 diabetes (10%), rheumatoid arthritis (RA, 8%), epilepsy (8%), major depressive disorder (MDD, 5%) and systemic lupus erythematosus (SLE, 3%). Most patients had not discussed a trial with their physician and only 21% had ever enrolled, with rates highest in ALS (36%), Parkinson’s disease (36%) and MS (20%) and lowest among SLE (9%), MDD (11%) and Fibromyalgia (11%). Common reasons for non-participation were eligibility criteria, inconvenience of travel and concerns about side effects. NPS suggested that many patients were unsatisfied; patients with lupus, epilepsy, RA, and fibromyalgia reported negative scores, i.e. they would dissuade other patients like them from taking part in trials. The most important considerations in trial participation were the opportunity to improve one’s own health and that of others, the reputation of the institution, and having medical bills covered in case of injury. Least important were remuneration and possibility of receiving a placebo. ALS patients were more willing to tolerate undesirable aspects of trials. Conclusions Most patients are willing to enroll yet very few are invited. When they do, trial participation is often burdensome, but patients are willing to help improve their design. Researchers should let patients help design better trials to overcome recruitment and retention issues and hasten the development of new medicines.
... 11 However, patient recruitment is a challenging and pressing issue for researchers as it has several barriers, including the lack of patient awareness of clinical trials and access to trials, age limitations, complex study designs, fewer eligible patients than expected due to restrictive eligibility criteria and several other reasons. 12,13,14 An analysis of registered trials showed that approximately 85% of trials were not able to complete required recruitment in the pre-defined time and around 20% of the trials were closed or terminated early due to inadequate patient recruitment, 15 limiting the statistical power of the evidence related to the new interventions. 16 Moreover, more than 70% of clinical trial generalizability assessment studies reported low generalizability of completed trials, partly due to low enrollment. ...
Preprint
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Dietary supplements (DSs) have been widely used in the U.S. and evaluated in clinical trials as potential interventions for various diseases. However, many clinical trials face challenges in recruiting enough eligible patients in a timely fashion, causing delays or even early termination. Using electronic health records to find eligible patients who meet clinical trial eligibility criteria has been shown as a promising way to assess recruitment feasibility and accelerate the recruitment process. In this study, we analyzed the eligibility criteria of 100 randomly selected DS clinical trials and identified both computable and non-computable criteria. We mapped annotated entities to OMOP Common Data Model (CDM) with novel entities (e.g., DS). We also evaluated a deep learning model (Bi-LSTM-CRF) for extracting these entities on CLAMP platform, with an average F1 measure of 0.601. This study shows the feasibility of automatic parsing of the eligibility criteria following OMOP CDM for future cohort identification.
... These include, but not limited to, the following: age, gender, occupation, level of educational achievement, and address. In clinical drug trials, especially in the US, demographic profiles for patient groups who take part In social and medical research, particularly in clinical drug trials, demographics are vital as they help to structure trial design and the recruitment of participants for research (Frank 2004). Precise demographic information (for example, age, gender, employment, and educational attainment) is key to successful research for pharmaceutical companies because it influences planning, distribution, and marketing strategies of their products as well. ...
Chapter
This chapter introduces the rationale, context, and main themes of the book. It explores what clinical drug trials are and why a sociological analysis of humaninvolvement is important. It provides a context of human involvement in clinical drug trials; this includes a discussion on the history of human involvement and interrogation of the volunteer as a concept. This chapter charts the changes to regulatory frameworks and how they brought about the shift from the use of captive populations to ‘volunteers’ capable of rational consent. It also includes a discussion on the commercial contexts in which clinical drug trials take place today.
... 4 We disseminate news about our trials by first using mass mailings, then the internet, then social media, and finally we promulgate useful templates for recruitment strategies among ourselves. 5 The Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia (TASTE) trial 2 that successfully recruited patients in Scandinavia based on drawing potential subjects from an underlying and well-developed registry demonstrates the possibility of success when there is a solid patient database available. ...
Article
Controlled clinical trials conduct the research that completes the causal argument between a treatment and a disease's control. Yet, this pinnacle of clinical research is itself afflicted. Chronic problems with recruitment failure vitiate the potency of our research efforts. In addition, the collision of end-point multiplicity (the drive to measure multiple end points) with the requirement of statistical parsimony (ie, the need to reduce the number of interpretable end points to control the overall type I error) induces a core inefficiency in clinical trial productivity by reducing the number of endpoints findings that are generalizable to the population at large. Unless clinical trialists engage these problems with vigor and imagination, our pinnacle may be nothing more than an inflection point leading to decline.
... These include, but not limited to, the following: age, gender, occupation, level of educational achievement, and address. In clinical drug trials, especially in the US, demographic profiles for patient groups who take part In social and medical research, particularly in clinical drug trials, demographics are vital as they help to structure trial design and the recruitment of participants for research (Frank 2004). Precise demographic information (for example, age, gender, employment, and educational attainment) is key to successful research for pharmaceutical companies because it influences planning, distribution, and marketing strategies of their products as well. ...
Chapter
Having critiqued voluntarism and altruism to situate healthy volunteering as an economic exchange and thus a form of labour, I now turn attention to the idea of the ‘giftrelationship’ (Titmuss 1971) as applied to humaninvolvement in clinical drug trials. I engage with literature on alturism in the blood donation context and how it relates to debates on human involvement in clinical drug trials. Arguing that while healthy volunteers gave altruism as their motivation in some cases, it is important for altruism in clinical drug trials to be considered in a critical manner. Appeals to altruism obscure power relations and inequality in clinical drug trials in that volunteering tends to attract people who are in financially disadvantaged situations. The use of altruism as motivation or explanation for involvement in clinical drug trials suggests the availability of willing participants who come forward with abandon to take part. Such a view negates how acts of altruism and voluntarism are shaped by the sociopolitical, sociocultural, and socioeconomic contexts in which they take place and that many healthy volunteers in clinical drug trials are actually coerced to take part in clinical drug trials.
... Patient recruitment and enrollment are critical factors for successful clinical trial research. 1 Moreover, subject recruitment is the most common problem in most clinical trials. 2 One of the main barriers to enrolling subjects is physicians' time needed to identify appropriate trials for patients. 3 For example, to determine whether new patients may be eligible for a clinical trial, physicians need to search multiple clinical trial repositories and read through the eligibility sections of several protocol documents. ...
Article
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A natural language processing (NLP) application requires sophisticated lexical resources to support its processing goals. Different solutions, such as dictionary lookup and MetaMap, have been proposed in the healthcare informatics literature to identify disease terms with more than one word (multi-gram disease named entities). Although a lot of work has been done in the identification of protein- and gene-named entities in the biomedical field, not much research has been done on the recognition and resolution of terminologies in the clinical trial subject eligibility analysis. In this study, we develop a specialized lexicon for improving NLP and text mining analysis in the breast cancer domain, and evaluate it by comparing it with the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT). We use a hybrid methodology, which combines the knowledge of domain experts, terms from multiple online dictionaries, and the mining of text from sample clinical trials. Use of our methodology introduces 4243 unique lexicon items, which increase bigram entity match by 38.6% and trigram entity match by 41%. Our lexicon, which adds a significant number of new terms, is very useful for matching patients to clinical trials automatically based on eligibility matching. Beyond clinical trial matching, the specialized lexicon developed in this study could serve as a foundation for future healthcare text mining applications.
... This makes recruitment of participants especially those with poor literacy challenging. [9][10][11] A study conducted by Michael Pascha et al. recommended that the informed consent must have the readability of 4 th grade to ensure that participants understand it and autonomy is maintained [12] and use of lucid language for drafting the ICDs should be encouraged. There is a need for investigators to work with the pharmaceutical industry to develop consent forms that are comprehensible. ...
Article
Purpose: A committee chaired by Dr. Ranjit Roy Chaudhary suggested accreditation of investigators, sites and ethics committees to improve the quality of trial conduct in the country. Prior to accreditation, understanding the challenges faced at the sites by investigators could help define the extent of the problem and identify potential solutions. Hence, we conducted the present study. Methods: Institutional Ethics Committee approval and written informed consent was obtained prior to enrolment. A checklist and a questionnaire was used to assess compliance to Quality Council of India (QCI) standards and the challenges faced by the sites and investigators respectively. Mumbai based investigators listed in the Clinical Trial Registry of India (CTRI) were enrolled. The responses obtained were analysed descriptively. The responses to each question in the checklist were calculated as a proportion and response to each item in the questionnaire was calculated in frequency and percent frequency. All the analysis was done using Microsoft Excel version 2013. Results: A total of 30 investigators from 69 clinical trial sites agreed to participate. We found that over 80% of the sites complied with standards recommended by the QCI guideline. The most frequently reported issues at the site were lack of space for archival (25%), no System to evaluate adequacy of training (31.81%) and lack of understanding of the technical language of the informed consent form (39.02%). Conclusion: There is a need of coordinated effort between all the stakeholders to improve the clinical trial conduct at the site.
... Studies discussed in the literature demonstrate that recruiting adequate number of participants, and selecting more number of locations have always been the greatest challenges which has an enormous impact on the cost and time taken for the product reach the market. 11,18,31 It has been found that participant enrolment, selection of locations and trial duration are some of the challenges faced during the clinical trial execution process. Hence, these three variables are considered the dependent variables for this study. ...
Article
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p class="abstract">Developing new medical devices require extensive clinical investigations to enter the market successfully. In recent years, India has emerged as one of the attractive and most preferred countries to carry out clinical trials, primarily due to diverse human gene pool and cost-competitiveness. However, unlike other healthcare products such as therapeutic drugs, there is a lack of regulations over usage of medical devices. Moreover, prior systematic empirical analysis that examine the medical device based clinical trials is also not well established. This study attempted to ascertain the determinants of participant recruitment, selection of locations and time taken to conduct medical device clinical trials. Medical devices that are clinically tested in India in the period of 2008 to 2014 were obtained from CTRI website. 108 out of 279 records were identified as medical device clinical trial registrations. Collected data was analyzed to know the device type, disease category, sponsors involved, participant enrolment, locations and the duration of the device trial. In this study, the category of sponsorship, device type and disease category were found to have significant influence with respect to the selection of number of participants, locations and the time taken to execute medical device clinical trials.</p
... For various reasons, knowledge can be a major factor in participation. First, low knowledge or confusion about the key facts of trial methods (random allocation, informed consent, standard treatment) can disrupt participation (46). Secondly, patients are often reluctant to participate in something about which they have little knowledge (47). ...
Article
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Background: Randomized clinical trials have been considered as the gold standard for evaluating the effectiveness and safety of medical interventions; however, there are major barriers to their design, conduct, analysis, and reporting. They are multidisciplinary and involve different steps and face a variety of challenges that may vary from one country to another. The aim of this study was to provide a comprehensive presentation of the challenges of clinical trial studies in different steps including design, conducting, analysis, and reporting. Methods: In this study, all original articles conducted during 1991-2017 that reviewed the barriers to clinical trial studies at one of the steps of design, conducing, analysis, and reporting of the results in Medline (through PubMed), Embase, Web of Sciences, Scopus, and Google Scholar were considered. The searched keywords were as follow: challenges, barriers, and randomized clinical trial. Results: The following barriers in different steps of randomized clinical trials were identified: general barriers include insufficient knowledge and understanding of clinical research and research methodology, barriers to ethical and regulatory systems, and lack of funding. The investigator-initiated trials may face similar problems to those of sponsor-initiated trials, such as handling regulatory systems, administrative and financial issues, multiple languages, and different patient compensation approaches. The challenge related to design was poor planning. Other challenges were lack of manpower and financial resources, inappropriate statistical methods for analysis (analysis challenges), and challenges related to reporting which include selective reporting. Conclusion: Based on the results of this systematic review, the most important challenges were barriers related to handling ethical and regulatory systems, patient recruitment, and lack of budget and skilled staff for conducting clinical trials. Training to improve the quality of randomized clinical trial studies in different steps and levels was the most important recommendation in these studies.
... das Argument weiter oben und Katz et al. 2008), während man sich uneinig darüber ist, warum Frauen insgesamt seltener an klinischen Studien teilnehmen, sofern sie nicht explizit ausgeschlossen werden. Zudem könnten eine schlechte Informationspolitik oder ein Bias auf Seiten der Studienleiter weitere Hindernisse darstellen (Frank 2004). Um den Anspruch auf gerechtere deskriptive Repräsentation von Frauen und Schwarzen sowie insbesondere von Schwarzen Frauen aus intersektionaler Perspektive besser einordnen zu können, muss genauer auf den Umgang mit biologischer Differenz als biomedizinpolitischem Problem eingegangen werden -auch hier hilft ein analytischer Blick in die Geschichte. ...
Chapter
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Wie können wir intersektionale Biopolitiken der Biomedizin beschreiben? Inwiefern spielten intersektionale Macht- und Wissensordnungen bei der "Geburt" und "Produktion" der HeLa-Zelle eine Rolle? Und welcher Bedeutung kommen Repräsentationstechniken bei dem Design klinischer Studien zu?
... Pertinent historical background encompassing more than four decades consistently highlights the challenges of timely, reliable, and appropriately selective patient recruitment. 12,13 Moreover, the increased emphasis on speed of enrollment has, at times, unwittingly overridden quality, the resulting statistical variance, vis-à-vis an over-abundance of sites per study, further escalating the ever-increasing placebo response phenomenon, which has contributed to numerous "failed studies," whereby even the marketed reference compounds did not statistically separate from placebo. 14 This had led many to question whether clinical trials in the US are enrolling the most appropriate patients. ...
Article
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The much-anticipated 2014 European Union (EU) Clinical Trial Regulation requiring Layperson/ Plain Language Summaries (PLS) is slated for implementation in 2020. At the 10th Annual CNS Summit Conference (Fall 2019), a panel discussion was convened with the objective of evaluating the likelihood of the PLS legislation being implemented successfully in the EU and voluntarily (e.g., pro-actively) in the rest of the world. Points of the discussion embraced the notion that this is an excellent opportunity for the entire pharmaceutical industry. Moreover, in the United States, public opinion of the pharmaceutical industry hit an all-time low in 2019, surpassing the oil industry with regard to public distrust. For decades, clinical trial participants have stated that wanting to learn, in layperson terms, the results of the study was second only to wanting to learn the treatment group into which they were assigned under double-blind conditions. Our conclusion is that while confidentiality, commercial interests, total costs, regulatory concerns, as well as some operational aspects (i.e., patient access portals) are among the hurdles, our commentary strongly advocates systematic implementation not only within the EU, but that this should be implemented globally, without further delay.
Article
Planning for vaccines manufacturing capacity is both a complex task requiring many inputs and an important function of manufacturers to ensure the supply of vaccines that prevent life-threatening illnesses. This thesis explores the development of an operations based long range capacity planning model to facilitate the annual strategic capacity planning review at Novartis Vaccines. This model was developed in conjunction with process owners at Novartis Vaccines and utilizes operations principles, non-linear optimization, and process data to efficiently calculate the capacity of the vaccine manufacturing network. The resulting network capacity is then compared to the long range demand for vaccine production to determine capacity deficits and surpluses in the current manufacturing network as well as analyzing options for more efficient capacity usage. Although this model was developed specifically with respect to the Novartis Vaccines manufacturing network, the capacity calculation and gap analysis tools for single and multiproduct facilities as well as batch allocation for in multi-product, multi-facility networks are also applicable to other companies and industries that utilize batch processing. The model was validated utilizing process information from a production line that was already operating near capacity and showed a 95% agreement with the data from this line. Additionally, this operations based planning model was able to achieve buy-in from both process owners and the global strategy organization allowing it to be implemented in the planning cycle. Use of this tool enables efficiency and transparency in capacity analysis as well as the tools to examine the impact of a range of scenarios on the manufacturing network.
Conference Paper
One of the major challenges of community-based research is recruitment of community members who will participate in clinical trials, continue for the duration of the trial, and provide accurate, sensitive personal information. This challenge can be overcome by establishing greater trust between researchers and communities. This study focused on designing a system to address trust issues between a community and clinical researchers. The study described a methodology for translating non-functional wants and needs into technical requirements that were used as input to a Service-Oriented Architecture (SOA) approach to design a solution. Unlike a typical SOA that is derived from a single enterprise's business goals and processes, this solution was based on multiple stakeholder goals and general clinical trial processes. The resulting architecture focused on improving communication between researchers and communities and was validated by mapping the technical requirements against a trust-building model and by modeling the solution using Petri nets.
Chapter
This comprehensive, evidence-informed text provides clinicians, researchers, policy-makers and academicians, with content to inform and enrich the guidelines recommended by the National Consensus Project and the National Quality Forum Preferred Practices. It is designed to meet the needs of health social work professionals who seek to provide culturally sensitive biopsychosocial-spiritual care for patients and families living with life-threatening illness. Edited by two of the leading social work clinician-researchers in the US, this text serves as the definitive resource for practicing clinicians and fulfils the need for social work faculty who wish to complement general health care texts with information specific to palliative and end-of-life care.
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Since 2007, the US federal government has required that organizations sponsoring clinical trials with a least one site in the United States submit information on these clinical trials to an existing database: ClinicalTrials.gov. Over time, the number of mandatory variables has grown and will probably continue to grow. The database now represents an important source of descriptive information about the landscape for clinical trials. In addition, it constitutes a rich pool of data to test hypotheses—for instance, what variables are associated with an organization’s ability to correctly estimate study completion times or complete those studies in as short a time frame as possible. This paper concludes that for mandated variables that the authors have labeled study identification, protocol and study design, and study execution, the data set constitutes a potentially very valuable research resource. With the exception of some site-related information, incomplete data did not exceed 3%. The incomplete site data are concentrated in several companies, so it is not unreasonable to assume that those data will also become more complete.
Article
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There are several aspects of the requirement to provide for an equitable sampling of research participants. On the one hand, equitable sampling implies that the scientific research objectives shall be the cornerstone for determining the groups and individuals to be selected and included as research participants, rather than some other properties which are unrelated to research objectives (such as the subjects' vulnerability or privileges]. On the other hand, groups and individuals should not be denied the opportunity to participate in scientific research without a solid scientific justification. The concept of equitable sampling also implies that groups and individuals that have borne the risks and burden of research should enjoy some benefit from the research. The unjustified and excessive inclusion of certain groups as research participants is equally unfair and inequitable as their unjustified and excessive exclusion from research. In many cases, the excessive inclusion of some groups is often based on the administrative availability of population rather than on the scientific rationale, which is considered unacceptable. In the British and American law, the sampling of research participants has to be a reflection of the multi-cultural society, which implies taking into account the participants' ethnicity, gender, disability, age and sexual orientation in the process of planning, executing and implementing the research plan. However, literature shows that the exclusion of some groups from participation in the research is not the most important issue in sampling but whether it concurrently implies the exclusion from the benefits stemming from the research results, which would be unfair. In addressing these issues, the literature differentiates between equitable sampling in terms of benefits from a quantitative research and equitable sampling in terms of benefits from a qualitative research. Generally, sampling in the quantitative research is considered to be of interest only if the research is most likely to yield substantial difference in the effects of including a particular group (for example, in case of testing the effects of some medications]. Otherwise, the research results will be applied across all groups regardless of who the research participants are. Factors such as ethnicity, sex, gender or economic status are most likely indicators of tangible cultural differences. In case the exclusion of some group from a quantitative research has some political implications, it is prima facie inequitable. In principle, if the researchers in qualitative research are free to study the cultural, social and societal issues that kindle their curiosity, then the population diversity will be more significantly reflected in the content of research findings.
Article
Background Some industry observers and medical professionals, and even the popular media, assert that pharmaceutical companies are conducting an increasing number of clinical trials in countries outside the more established geographies of North America and Western Europe as a way to minimize costs, speed clinical trial completion and reduce regulatory oversight. This raises a number of medical and ethical issues. Aim We sought to establish the degree to which pharmaceutical companies, between 2008 and 2012, have moved phase 3 clinical trials from the traditional research geographies of North America and Europe to less economically developed geographies. Methods We present descriptive summaries of our findings from ClinicalTrials.gov. To test the significance of our findings, we designed a mixed logistic regression analysis with the outcome variable designated as whether or not the site was a site within a traditional clinical trial market. Results The results demonstrate that there has been very little overall change between 2008 and 2012 where phase 3 studies are conducted. There is virtually no shift in the distribution of studies conducted in the traditional clinical trial areas of North America and Western Europe. Across the five-year window, the percentage of North American sites was 39 % while the percent of sites in Western Europe barely changed from 26 to 25 %. Conclusions There was little change in the geographic distribution of phase 3 sites during the period covered by the analysis.
Chapter
Achieving clinical trial research participant enrolment is clearly essential to conducting a successful trial. Adequate enrolment provides a basis for projected participant retention, resulting in evaluative patient data. Without sufficient patient retention from the time of study initiation to closeout, the number of remaining participants may prove to be too small a pool from which to derive conclusive proof or disproof of the goal of the clinical trial sponsor. Obtaining final evaluative data is dependent on successful patient retention. Patients cannot be retained without an initial pool of enrolled volunteers. This initial pool of screened, then enrolled, participants depends on designing a successful patient recruitment strategy. ‘A major focus in all clinical trials is on the recruitment of subjects. Where and how to do this depends on the demographics of the target population and the condition under investigation’. [1, 2].
Chapter
Drawing on statistical data, this chapter illustrates the considerable variations in the backgrounds of healthy volunteers. I present the demographic profiles of healthy volunteers and introduce the relationship between income, financial rewards, and financial security. I illustrate how healthy volunteering in the UK may not be delineated purely as the preserve of marginalised and unemployed individuals. Rather, based on the sample used in the research informing this book, it appears that healthy volunteers in the UK are mostly employed in full-time and relatively well-paid jobs. I argue that healthy volunteer involvement should be seen in the context of rising costs of living and that this makes taking part in clinical drug trials a worthwhile option for some people.
Article
Background: Patient and clinician stakeholders are inadequately engaged in key aspects of research, particularly regarding use of Big Data to study and improve patient-centered outcomes. Little is known about the attitudes, interests, and concerns of stakeholders regarding such data. Research design: The New York City Clinical Data Research Network (NYC-CDRN), a collaboration of research, clinical, and community leaders built a deidentified dataset containing electronic health records from millions of New Yorkers. Guided by a patient-clinician advisory board, we developed a question guide to explore patient and clinician experiences and ideas about research using large datasets. Trained facilitators led discussions during preexisting patient, community, and clinician group meetings. The research team coded meeting notes and identified themes. Results: Fully 272 individuals participated in 19 listening sessions (139 patients/advocates, 133 clinicians) at 6 medical centers with diverse NYC communities: 76% were female and 63% were nonwhite. Clinicians and patients agreed on all major themes including the central role of clinicians in introducing patients to research and the need for public campaigns to inform stakeholders about Big Data. Stakeholders were interested in using granular data to compare the care and clinical outcomes of their neighborhoods with others across NYC, but were also concerned that data could not truly be deidentified. Conclusions: Clinicians and patients agree on potential benefits of stakeholder-engaged Big Data research and provided suggestions for further research and building stakeholder research capacity. This evaluation demonstrated the potential of brief meetings with existing patient and clinical groups to explore barriers and facilitators to patient and clinician engagement.
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Clinical trials are essential for discovering new treatments, but there are multiple challenges to patient recruitment, patient engagement, and cost containment. Virtual clinical trials (VCT) are an innovative approach that provides potential solutions by conducting home-based, rather than site-based, clinical trials. Virtual clinical trials are still the exception rather than general practice due to technical barriers. "Blockchain," a distributed ledger technology, is a perfect match for virtual clinical trials. Its peer-to-peer design, security settings, and data transparency meet the needs of many healthcare applications. The programmable "Smart Contract" feature makes blockchain more suitable and feasible for VCT by solving computational issues. Our previous work has shown the power of applying blockchain to clinical trial recruitment. This work develops a comprehensive blockchain framework, with simulations and case studies, including patient recruitment, patient engagement, and persistent monitoring modules.
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Clinical trials are the gatekeepers and bottlenecks of progress in medicine. In recent years, they have become increasingly complex and expensive, driven by a growing number of stakeholders requiring more endpoints, more diverse patient populations, and a stringent regulatory environment. Trial designers have historically relied on investigator expertise and legacy norms established within sponsor companies to improve operational efficiency while achieving study goals. As such, data-driven forecasts of operational metrics can be a useful resource for trial design and planning. We develop a machine learning model to predict clinical trial operational efficiency using a novel dataset from Roche containing over 2,000 clinical trials across 20 years and multiple disease areas. The data includes important operational metrics related to patient recruitment and trial duration, as well as a variety of trial features such as the number of procedures, eligibility criteria, and endpoints. Our results demonstrate that operational efficiency can be predicted robustly using trial features, which can provide useful insights to trial designers on the potential impact of their decisions on patient recruitment success and trial duration.
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Bringing treatments for rare genetic diseases to patients requires clinical research. Despite increasing activism from patient support and advocacy groups to increase access to clinical research studies, connecting rare disease patients with the clinical research opportunities that may help them has proven challenging. Chief among these challenges are the low incidence of these diseases resulting in a very small pool of known patients with a particular disease, difficulty of diagnosing rare genetic diseases, logistical issues such as long distances to the nearest treatment center, and substantial disease burden leading to loss of independence. Using clinical studies of phenylketonuria as an example, this paper discusses how, based on the authors' collective experience, partnership among clinicians, patients, study coordinators, genetic counselors, dietitians, industry, patient support groups, and families can help overcome the challenges of recruiting and retaining patients in rare disease clinical trials. We discuss specific methods of collaboration, communication, and education as part of a long-term effort to build a community committed to advancing the medical care of patients with rare genetic diseases. By talking to patients and families regularly about research initiatives and taking steps to make study participation as easy as possible, rare disease clinic staff can help ensure adequate study enrollment and successful study completion.
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This study examines attitudes that may deter black women from participating in cancer research. Subjects were recruited from women who did not respond to the initial recruitment mailing for the Women's Health Initiative. Each subject was administered a 7- to 10-minute telephone survey. One third (29) of the 80 subjects were black. Fifty-six percent of black women and 71% of white women had positive attitudes toward cancer clinical trials. More than 80% of the women surveyed agreed that clinical research benefits society and increases medical knowledge. However, almost one third of the black women agreed that scientists cannot be trusted while only 4% of whites responded similarly. Additionally, 29% of black women agreed that researchers did not care about them compared with 14% of white women. Only 28% of black women felt that clinical research in the United States was ethical, and 37% had a preference to be treated by a black scientist compared with 2% of whites. Controlling for other covariates, black women had more negative altitudes overall to clinical trials than white women. These findings support the likelihood that barriers exist for the participation of blacks and other minorities in clinical research. These barriers may impact the involvement of black women in cancer clinical trials. Improving trust and creating a perception of a caring attitude from investigators are important to overcoming these barriers. The inclusion of more black scientists as leaders of cancer clinical trials also may help improve these participation rates.
Article
Objectives To explore attitudes to and problems experienced with recruitment into randomised trials in cancer care. Methods In-depth semi-structured interviews with a purposive sample of 20 hospital clinicians in the South West of England identified from 192 participants in a larger postal survey. Interviews were recorded on audiotape and fully transcribed. Data were analysed by comparing transcripts and describing emergent themes. Results Clinicians do not always find it easy to identify key randomised trials in their area of interest. Even when they identify those trials in which they would like to participate, they are not always able to recruit patients. Although recruitment can be hindered by the time and administration involved and the resources needed, the attitudes of clinicians to research in general, the design of randomised trials, clinicians' concerns regarding individual patients and patients' preferences for different treatments also present major barriers. Other factors of concern include the imposition of strict eligibility criteria and the expense and complexity of monitoring and follow-up. Conclusion Barriers to recruitment depend on the clinicians' individual situations and on a complex combination of factors. Action is needed to promote awareness of randomised trials under way, to ensure that trials address issues of importance, are acceptable to patients and clinicians, and that practical support is provided for participating centres.
Article
We report on recruiting and retaining a sample of low birth weight, premature infants for a clinical trial as well as results of tests evaluating sampling and retention biases. A total of 4551 infants were screened, and 1302 were found eligible. Consent was obtained for 1028 infants. After randomization and the presentation of group assignment, the number of infants enrolled was 985 (75.7% of those eligible). Of these, 92.7% completed the 3-year study. Tests to evaluate recruitment bias revealed significant relationships between nonenrollment and site, maternal race, and infant birth weight. Tests to evaluate retention bias revealed a significant relationship between dropout and maternal education. Additionally, infant birth weight and maternal age interacted with treatment in predicting dropout. Despite these statistically significant recruitment and retention biases, there was no evidence of problems with sample representativeness to the population of interest or of treatment group differences on study-relevant background variables. J Dev Behav Pediatr 14:1-7, 1993. Index terms: bias, infant, recruitment, retention, sample. (C) Lippincott-Raven Publishers.
Article
The purpose of this study was to qualitatively assess attitudes associated with the willingness of African-Americans to participate in prostate cancer clinical trials. Fifty-six African-American males, 40 years of age and older, were recruited from South Central Los Angeles. Respondents were divided into lower or middle socio-economic groups based on education and occupation. Focus group discussions were conducted to assess their knowledge about prostate cancer and willingness to participate in prostate cancer clinical trials. In addition, information was obtained to identify their incentives and barriers towards participating in prostate cancer research. Middle socio-economic respondents expressed a greater willingness to participate in prostate cancer clinical trials than did men of lower socio-economic status. Many indicated that they would be more likely to participate if they were encouraged to do so by a physician or researcher who was viewed as being competent and compassionate. Barriers to participation in prostate cancer clinical trials included concerns about drug toxicity, medical experimentation and distrust of the medical establishment. Endeavors aimed at increasing minority representation in prostate cancer clinical studies should address these issues.
Article
The purpose of this study was to evaluate the effect of physician recommendation on whether to enroll in a randomized controlled chemoprevention trial for breast cancer. We surveyed 360 women who were at increased risk for breast cancer regarding social and behavioral factors that could influence their decision to enroll or not to enroll in the Breast Cancer Prevention Trial (BCPT). Respondents completed a questionnaire following attendance at an informational session about the trial. The analysis was restricted to 175 women who discussed the possibility of their participation in the trial with their primary care physician (PCP) and who reported what their physician advised them to do regarding participation. Logistic regression modeling showed that among women who discussed the trial with their physician, physician recommendation was the most important factor that influenced the respondent's decision to enroll in the BCPT. Women who reported that their physician advised them to enroll in the trial were 13 times more likely to participate than were women who reported that their physicians advised them not to participate. The results of our study show that PCPs play an important role in influencing preventive health behavior, specifically, regarding enrollment in a randomized breast cancer chemoprevention trial. Efforts to increase recruitment to a trial should include enlisting the support of PCPs.
Article
To create a more meaningful understanding of the informed consent process as it has come to be practiced and regulated in clinical trials, this discussion uses the experience gained from the conduct of therapeutic research that involves cancer patients. After an introduction of the ethical tenets of the consent process in clinical research that involves potentially vulnerable patients as research subjects, background that details the use of written consent documents and of the term "informed consent" is provided. Studies from the cancer setting that examine the inadequacies of written consent documents, and the outcome of the consent process itself, are reviewed. Two ethically challenging areas of cancer clinical research, the phase I trial and the randomized controlled trial, are discussed briefly as a means of highlighting many dilemmas present in clinical trials. Before concluding, areas for future research are discussed. Through an exclusive cancer research perspective, many current deficiencies in the informed consent process for therapeutic clinical trials can be critically examined. Also, new directions for improvements and areas of further research can be outlined and discussed objectively. The goals of such improvements and research should be prevention of further misguided or ineffective efforts to regulate the informed consent process. To ignore this rich and interesting perspective potentially contributes to continued misunderstanding and apathy toward fulfilling the regulatory and ethically obligatory requirements involved in an essential communication process between a clinician-investigator and a potentially vulnerable patient who is considering clinical trial participation.
Article
The multiple determinants of a patient's decision to enter into a clinical trial have been explored largely from the perspectives of patients and their physicians. Little research has involved clinical research associates (CRAs) formally, despite their central role in the process of recruitment. The current study was initiated to explore the factors that influence the decision of patients with cancer regarding clinical trial entry, specifically from the perspective of the CRA. Two focus groups of CRAs from the Hamilton Regional Cancer Center were organized. A skilled facilitator guided both groups through exploratory and subsequent confirmatory phases of discussions, which were audiotaped for review and coding using a process of consensus employing intercoder triangulation. The two groups identified a number of factors that they believed influenced the recruitment process. Numerous physician and patient factors were reaffirmed, such as the impression of the scientific merit of a study or the sense of personal benefit, respectively. More uniquely, CRAs identified information transfer within the informed consent process as a major aspect of their specialized role. It was believed that full disclosure of information, in terms of both the content and the techniques and styles of delivery, was an important predictor of recruitment success. The groups quickly reached consensus on which factors they believed were the most important overall with respect to influencing study recruitment. CRAs appear to have a unique role in the process of recruiting patients to active clinical trials. They believe that they have an important influence on recruitment success. Further research to validate this impression is required, because, ultimately, a greater understanding of the relative roles of physician and patient factors and, potentially, CRA factors will be important in the development of ethical and supportive strategies to optimize the recruitment of patients with cancer into randomized clinical trials.
Discussion Re: Temple University School of Pharmacy Quality Assurance/ Regulatory Affairs
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Clinical trials in general practice: recruitment models. Presented at the International Clnical Trials Symposium
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Factors influencing enrollment in clinical trials for cancer treatment
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Schilsky, RL. Conversations in Care -Chapter 7, Meeting the Challenges of Clinical Trial Enrollment. Web-book. http: //www.conversations incaes.com/ web_book/chapter07.html. Viewed 16 April 2003. Quoted from Klabunde CN, Springer BC, Butler B, White MS, Atkins J. Factors influencing enrollment in clinical trials for cancer treatment. South Med J. 1999:92(12): 1189-1193.
why don't they come to Pike Street and ask us?: " Black American women's health concerns
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Schilsky, RL. Conversations in Care -Chapter 7, Meeting the Challenges of Clinical Trial Enrollment. Web-book. http: //www.conversations incaes.com/ web_book/chapter07.html. Viewed 16 April 2003. Quoted from Freedman TG. "why don't they come to Pike Street and ask us?: " Black American women's health concerns. Soc Sci Med. 1998;47(7): 941-947.
Quoted from Jenkins V, Fallowfield L. Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy
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Schilsky, RL. Conversations in Care -Chapter 7, Meeting the Challenges of Clinical Trial Enrollment. Web-book. http: //www.conversations incaes.com/ web_book/chapter07.html. Viewed 16 April 2003. Quoted from Jenkins V, Fallowfield L. Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy. Br J Cancer. 2000;82(11):1783-1788. 30 WOMEN AND MINORITY RECRUITMENT: INTERVENTION TESTING. NIH GUIDE, Volume 25, Number 1, January 26, 1996. RFA: CA-96-004. P.T. 34, FF, II. http:// grants1.nih.gov/grants/guide/rfafiles/ RFA-CA-96-004.html. Viewed 06 June 03.
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