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Commentary: Improving Participant Recruitment in Clinical and Translational Research
Abstract
In this issue of Academic Medicine, Kitterman and colleagues report the results of an evaluation of the prevalence and cost of low-enrolling studies (zero or one participant enrolled) conducted at Oregon Health & Science University (OHSU). They found that one-third of all studies terminated between 2005 and 2009 at OHSU had low enrollment and that these low-enrolling studies cost the institution almost $1 million annually. The recruitment of research participants is critical to conducting clinical and translational research. Failure to recruit research participants has a negative financial impact, but, more importantly, underenrolled studies do not contribute to scientific or clinical knowledge. In this commentary, the authors describe four areas in which academic health centers (AHCs) could invest more effort and resources to improve the recruitment of research participants. First, more planning and resources should be put into determining the feasibility of participant recruitment. Second, studies that are underenrolling should be terminated early to prevent unethical research, to save financial and other resources, and to allow these resources to be applied to successful research. Third, AHCs should professionalize, centralize, and automate participant recruitment. Fourth, AHCs should take a leadership role in partnering with the public to improve participation in clinical research. Participant recruitment must be improved if clinical and translational research is to meet its promise of improving health.
... In many cases, multiple -rather than single -recruitment strategies are used (e.g. . Some suggest (e.g. that recruitment is the most challenging aspect of any study and yet it is a key 4 video journal of education and pedagogy (2020) [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] determinant of the results . Others bemoan the lack of attention given to recruitment in the literature (e.g. . ...
... Taking this into account, I created a short recruitment video which I posted on YouTube and shared on social media, mainly through my Twitter account and my blogsite. The video lasted three minutes and showed me in my office holding a cup of tea, talking about the rationale for my study and the kind of 6 video journal of education and pedagogy (2020) [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] teachers I was hoping to attract. My main reason for posting the video was to be seen as approachable, credible and sensitive. ...
... The video was created in March 2017 (posted on YouTube: 30/03/2017), as part of the recruitment strategy for my doctoral study (Culshaw, 2019a). I was 8 video journal of education and pedagogy (2020) [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] looking for teachers who would be willing to talk about their experience of struggling. The video can be viewed here: https://www.youtube.com/watch?v= 3S_wlotcuF4 ...
This article presents an innovative, video-based approach to the recruitment of research participants. A YouTube video was created and uploaded as part of a doctoral study exploring what it means to be struggling as a teacher. Following a review of the recruitment literature, which highlights a general lack of attention paid to the challenges of recruitment, the author explores the approach she took in planning the video. The video was the main promotional tool for the study and was communicated via Twitter and email. She also presents online survey findings on the perceived impact and influence of the video; the visual format, informal tone and the ability to see the researcher in person were rated very positively. A reflective analysis of the video transcript follows drawing on the literature as well as the survey findings. She concludes that video-based recruitment can be an inexpensive but powerful tool which allows a human connection with the researcher early on in the research process.
... Participant retention is the continuous engagement of the participant in the research study, post enrollment [6]. While achieving the required sample size for recruitment and retention is critical for robust statistical power, and study validity [2,[7][8][9][10], achieving the targeted sample in terms of number or timespan is challenging [2,5,7,[10][11][12][13][14][15][16][17][18][19]. It was reported that only 55% of clinical studies accrue their total targeted sample size, and 78% accrue 80% of their targeted sample size [18]. ...
... Participant retention is the continuous engagement of the participant in the research study, post enrollment [6]. While achieving the required sample size for recruitment and retention is critical for robust statistical power, and study validity [2,[7][8][9][10], achieving the targeted sample in terms of number or timespan is challenging [2,5,7,[10][11][12][13][14][15][16][17][18][19]. It was reported that only 55% of clinical studies accrue their total targeted sample size, and 78% accrue 80% of their targeted sample size [18]. ...
... It was reported that only 55% of clinical studies accrue their total targeted sample size, and 78% accrue 80% of their targeted sample size [18]. Recruitment and retention issues can adversely affect the ability to detect intervention effects and may limit the significance of the research findings [2,5,7,20]. ...
Background:
Recruitment and retention strategies for patient-centered outcomes research are evolving and research on the subject is limited. In this work, we present a conceptual model of patient-centered recruitment and retention, and describe the recruitment and retention activities and related challenges in a patient-centered comparative effectiveness trial.
Methods:
This is a multicenter, longitudinal randomized controlled trial in localized prostate cancer patients.
Results:
We recruited 743 participants from three sites over 15 months period (January 2014 to March 2015), and followed them for 24 months. At site 1, of the 773 eligible participants, 551 (72%) were enrolled. At site 2, 34 participants were eligible and 23 (68%) enrolled. Of the 434 eligible participants at site 3, 169 (39%) enrolled. We observed that strategies related to the concepts of trust (e.g., physician involvement, ensuring protection of information), communication (e.g., brochures and pamphlets in physicians' offices, continued contact during regular clinic visits and calling/emailing assessment), attitude (e.g., emphasizing the altruistic value of research, positive attitude of providers and research staff), and expectations (e.g., full disclosure of study requirements and time commitment, update letters) facilitated successful patient recruitment and retention. A stakeholders' advisory board provided important input for the recruitment and retention activities. Active engagement, reminders at the offices, and personalized update letters helped retention during follow-up. Usefulness of telephone recruitment was site specific and, at one site, the time requirement for telephone recruitment was a challenge.
Conclusions:
We have presented multilevel strategies for successful recruitment and retention in a clinical trial using a patient-centered approach. Our strategies were flexible to accommodate site-level requirements. These strategies as well as the challenges can aid recruitment and retention efforts of future large-scale, patient-centered research studies.
Trial registration:
Clinicaltrials.gov , ID: NCT02032550 . Registered on 22 November 2013.
... 1 One of the three priorities identifi ed was Reengineering the Clinical Research Enterprise to support clinical research and to bring the promise of scientifi c discovery to patients in order to improve health. 1 One problem facing the clinical research enterprise is the frequent failure of clinical studies in academic medical centers (AMC) to meet enrollment goals. 2,3 Under-enrolled studies fails to answer important clinical questions but may also have a signifi cant fi nancial impact on AMC. 2,3 One of the barriers to patient enrollment is a lack of professional and centralized research staff to automate the recruitment process. ...
... 2,3 Under-enrolled studies fails to answer important clinical questions but may also have a signifi cant fi nancial impact on AMC. 2,3 One of the barriers to patient enrollment is a lack of professional and centralized research staff to automate the recruitment process. [2][3][4] In 2010, the NIH site clinical trials.gov ...
... 2,3 One of the barriers to patient enrollment is a lack of professional and centralized research staff to automate the recruitment process. [2][3][4] In 2010, the NIH site clinical trials.gov listed 13,000 open trials. ...
Supporting clinical research is a national priority. Clinician scientists are rare and clinical trials in academic medical centers (AMC) often fail to meet enrollment goals. Undergraduate students interested in biomedical careers often lack opportunities to perform clinical research.
Describe an innovative undergraduate course that supports clinical research in an AMC.
The course, Clinical Research Methods and Practice, offers undergraduate students the opportunity to learn clinical research through didactic and practical experiences. The students in turn support clinician scientists' conduct of clinical studies in an AMC. Clinician scientists receive research support and participate in mentoring sessions for students.
Over seven semesters, 128 students have assisted in 21 clinical studies located in outpatient and inpatient units of two hospitals. Students identified and screened eligible patients, collected clinical data, assisted in obtaining informed consent, and transported specimens. Many of the clinician scientists have met their enrollment goals and several have been top-enrollers in multicenter clinical trials as a result of student support.
The Clinical Research Methods and Practice class addresses barriers to clinical research in AMC. This may be a model for institutions committed to mentoring students early in their career and to developing infrastructures for clinical research. Clin Trans Sci 2013; Volume 6: 94-97.
... Unfortunately, retaining subjects and ensuring adherence to the protocol are major challenges for clinical researchers [8][9][10]. The retention and adherence of subjects is necessary for the credibility, accuracy, and validity of research studies as low retention and adherence can reduce statistical power, lead to selection bias, and influence the significance of a study's findings [8,9,11,12] Additionally, a high number of subjects who withdrew and non-adherences can lead to a waste of resources and funds, create an excess burden on research coordinators, and ultimately lengthen the duration of studies causing delays in advancing medical knowledge and providing better care to patients [11]. ...
... Unfortunately, retaining subjects and ensuring adherence to the protocol are major challenges for clinical researchers [8][9][10]. The retention and adherence of subjects is necessary for the credibility, accuracy, and validity of research studies as low retention and adherence can reduce statistical power, lead to selection bias, and influence the significance of a study's findings [8,9,11,12] Additionally, a high number of subjects who withdrew and non-adherences can lead to a waste of resources and funds, create an excess burden on research coordinators, and ultimately lengthen the duration of studies causing delays in advancing medical knowledge and providing better care to patients [11]. ...
Background:
To investigate various patient-level variables, specifically socioeconomic status, as risk factors for withdrawal in a recently completed clinical study. We specifically investigated a non-interventional prospective study assessing the role of novel imaging as a biomarker for cancer upgradation in prostate cancer for this objective.
Methods:
In this retrospective analysis, we assessed the association between various patient-level factors including clinic-demographic factors, socioeconomic status, and the number of non-adherences with the participants' retention or withdrawal from the study. For socioeconomic status (SES), we used the zip code-based Economic Innovation Group Distressed Community Index (DCI) which classifies into five even distress tiers: prosperous, comfortable, mid-tier, at-risk, or distressed. Low SES was defined as those with a DCI Distress tier of at-risk or distressed. We compared values between the two retention and withdrawal groups using t-test, chi-square test, and logistic regression analysis.
Results:
Of 273 men screened, 123 men were enrolled. Among them, 86.2% (106/123) retained through the study whereas 13.8% (17/123) withdrew from the study. The mean (SD) age was 64 (6.4) years. Overall, 31.7% (39/123) were Hispanics and 24.3% (30/123) were African Americans. The median (IQR) DCI score was 34 (10.3, 68.1) and 30.8% (38/123) of patients belonged to low SES. The median DCI score in participants who retained in the study was statistically similar to those who withdrew from the study (p=0.4). Neither the DCI tiers (p=0.7) nor the low SES (p=0.9) were associated with participants' retention or withdrawal of the study. In terms of non-adherence, all participants in the withdrawn group had at least one non-adherent event compared to 48.1% in the retained group (p<0.001). Repetitive non-adherence was significantly higher in participants who withdrew from the study vs those who retained in the study [88.2% vs 16.9%, p <0.001]. On multivariate logistic regression analysis, the number of non-adherences (OR=12.5, p<0.001) and not DCI (OR=0.99, p=0.7) appeared to be an independent predictor for participants' retention or withdrawal from the study.
Conclusions:
Expanding diverse inclusion and limiting withdrawal with real-time non-adherence monitoring will lead to more efficient clinical research and greater generalizability of results.
... Unfortunately, retaining subjects and ensuring adherence to the protocol are major challenges for clinical researchers. 8,9,10 The retention and adherence of subjects is necessary for the credibility, accuracy, and validity of research studies as low retention and adherence can reduce statistical power, lead to selection bias, and in uence the signi cance of a study's ndings 8,9,11,12 Additionally, a high number of withdrawn subjects and non-adherences can lead to a waste of resources and funds, create excess burden on research coordinators, and ultimately lengthen the duration of studies causing delays in advancing medical knowledge and providing better care to patients. 11 While subject retention and protocol adherence are essential for successful research studies, little is known about the speci c factors that in uence subjects to complete a study and adhere to the protocol. ...
... 8,9,10 The retention and adherence of subjects is necessary for the credibility, accuracy, and validity of research studies as low retention and adherence can reduce statistical power, lead to selection bias, and in uence the signi cance of a study's ndings 8,9,11,12 Additionally, a high number of withdrawn subjects and non-adherences can lead to a waste of resources and funds, create excess burden on research coordinators, and ultimately lengthen the duration of studies causing delays in advancing medical knowledge and providing better care to patients. 11 While subject retention and protocol adherence are essential for successful research studies, little is known about the speci c factors that in uence subjects to complete a study and adhere to the protocol. We investigate various patient level variables as risk factors for withdrawal in a recently completed prostate imaging study in men to speci cally explore socioeconomic factors as potential barriers. ...
Background
To investigate various patient level variables, specifically socioeconomic status, as risk factors for withdrawal in a recently completed clinical study. We specifically investigate a recent study in men on adherence to an observational prostate cancer imaging and biomarkers study.
Methods
We performed a retrospective study to investigate risk factors for withdrawal in a prostate cancer imaging study that enrolled men on active surveillance from January 2016 to June 2019. For each subject, we assessed their retention status and collected demographic data. We compared values between the two retention groups using T-test, Chi-Squared, and logistic regression.
Results
Out of 273 men screened, 123 men were enrolled and included in the results of this study. Of those, 106 (86%) were retained in the study and 17 (14%) were withdrawn. While we found no significant relationship between low socioeconomic status and retention, we did find that the number of non-adherences was a significant factor in withdrawal from the study (OR 2.5, 95% CI 3.5–40.5, p < 0.001).
Conclusions
Expanding diverse inclusion and limiting withdrawal with real-time non-adherence monitoring will lead to more efficient clinical research and greater generalizability of results.
... Unfortunately, retaining subjects and ensuring adherence to the protocol are major challenges for clinical researchers. 8,9,10 The retention and adherence of subjects is necessary for the credibility, accuracy, and validity of research studies as low retention and adherence can reduce statistical power, lead to selection bias, and in uence the signi cance of a study's ndings 8,9,11,12 Additionally, a high number of withdrawn subjects and non-adherences can lead to a waste of resources and funds, create excess burden on research coordinators, and ultimately lengthen the duration of studies causing delays in advancing medical knowledge and providing better care to patients. 11 While subject retention and protocol adherence are essential for successful research studies, little is known about the speci c factors that in uence subjects to complete a study and adhere to the protocol. ...
... 8,9,10 The retention and adherence of subjects is necessary for the credibility, accuracy, and validity of research studies as low retention and adherence can reduce statistical power, lead to selection bias, and in uence the signi cance of a study's ndings 8,9,11,12 Additionally, a high number of withdrawn subjects and non-adherences can lead to a waste of resources and funds, create excess burden on research coordinators, and ultimately lengthen the duration of studies causing delays in advancing medical knowledge and providing better care to patients. 11 While subject retention and protocol adherence are essential for successful research studies, little is known about the speci c factors that in uence subjects to complete a study and adhere to the protocol. We investigate various patient level variables as risk factors for withdrawal in a recently completed prostate imaging study in men to speci cally explore socioeconomic factors as potential barriers. ...
Background:
To investigate various patient level variables, specifically socioeconomic status, as risk factors for withdrawal in a recently completed clinical study. We specifically investigate a recent study in men on adherence to an observational prostate cancer imaging and biomarkers study.
Methods:
We performed a retrospective study to investigate risk factors for withdrawal in a prostate cancer imaging study that enrolled men on active surveillance from January 2016 to June 2019. For each subject, we assessed their retention status and collected demographic data. We compared values between the two retention groups using T-test, Chi-Squared, and logistic regression.
Results:
Out of 273 men screened, 123 men were enrolled and included in the results of this study. Of those, 106 (86%) were retained in the study and 17 (14%) were withdrawn. While we found no significant relationship between low socioeconomic status and retention, we did find that the number of non-adherences was a significant factor in withdrawal from the study (OR 2.5, 95% CI 3.5-40.5, p<0.001).
Conclusions:
Expanding diverse inclusion and limiting withdrawal with real-time non-adherence monitoring will lead to more efficient clinical research and greater generalizability of results.
... These include geographical and time constraints, labor to recruit and retain participants, limited financial resources, and logistical difficulties associated with survey administration or intervention conduction [14]. Failure to recruit and retain a sufficient number of eligible participants can be costly [15], threatens internal and external validity of the study [16], and, most importantly, deprives the scientific community of knowledge and potentially useful interventions [15,17]. ...
... These include geographical and time constraints, labor to recruit and retain participants, limited financial resources, and logistical difficulties associated with survey administration or intervention conduction [14]. Failure to recruit and retain a sufficient number of eligible participants can be costly [15], threatens internal and external validity of the study [16], and, most importantly, deprives the scientific community of knowledge and potentially useful interventions [15,17]. ...
There are many challenges in recruiting and engaging participants when conducting research, especially with HIV-positive individuals. Some of these challenges include geographical barriers, insufficient time and financial resources, and perceived HIV-related stigma.
This paper describes the methodology of a recruitment approach that capitalized on existing online social media venues and other Internet resources in an attempt to overcome some of these barriers to research recruitment and retention.
From May through August 2013, a campaign approach using a combination of online social media, non-financial incentives, and Web-based survey software was implemented to advertise, recruit, and retain participants, and collect data for a survey study with a limited budget.
Approximately US 3.56 per survey initiation. A total of 1221 individuals completed the survey, yielding 86.97% retention.
These data indicate that online recruitment is a feasible and efficient tool that can be further enhanced by sophisticated online data collection software and the addition of non-financial incentives.
... A report from Oregon Health and Science University revealed that the university spent nearly $1 million in fiscal year 2009 on studies that terminated early because of low enrollment numbers [2]. Not only do these investments fail to produce any scientific results [3] but they also indirectly prevent other research studies from being conducted that could produce results. For these reasons, research dollars need to be allocated to recruitment activities that yield the greatest return on investment. ...
Introduction:Under enrollment of participants in clinical research is costly and delays study completion to impact public health. Given that research personnel make decisions about which strategies to pursue and participants are the recipients of these efforts, we surveyed research staff (n = 52) and participants (n = 4,144) affiliated with SPARK (Simons Foundation Powering Autism for Knowledge) – the largest study of autism in the U.S. – to understand their perceptions of effective recruitment strategies.
Methods:In Study 1, research personnel were asked to report recruitment strategies that they tried for SPARK and to indicate which ones they would and would not repeat/recommend. In Study 2, SPARK participants were asked to indicate all the ways they heard about the study prior to enrollment and which one was most influential in their decisions to enroll.
Results:Staff rated speaking with a SPARK-study-team member (36.5%), speaking with a medical provider (19.2%), word of mouth (11.5%), and a live TV news story (11.5%) as the most successful strategies. Participants most often heard about SPARK via social media (47.0%), speaking with a medical provider (23.1%), and an online search (20.1%). Research personnel’s and participants’ views on effective recruitment strategies often differed, with the exception of speaking with a medical provider.
Conclusion:Results suggest that a combination of strategies is likely to be most effective in reaching diverse audiences. Findings have implications for the selection of strategies that meet a study’s specific needs, as well as recruitment-strategy “combinations” that may enhance the influence of outreach efforts.
... In the literature, Nasser et al. have commented on the need to professionalize and automate the process of recruitment and provide an infrastructure of experienced professional recruiters in academic medicine. 45 They found that most academic health centers still rely on traditional study staff with little training or experience in recruitment and concluded that a centralized process would benefit both the participants and research organization. This is consistent with our findings, which extend the benefits of the CR model to the research enterprise by demonstrating feasibility in being able to support a large quantity of diverse studies. ...
Context
Insufficient recruitment is a barrier to research and limits statistical power. We describe an initiative aimed to streamline recruitment and consent processes for inpatients with spinal cord injury or disease (SCI/D) via implementation of a Central Recruitment (CR) process. The CR process adhered to ethical standards, reduced participant burden, and maximized research participation.
Methods
In this CR process, the inpatient’s nurse affirmed suitability for research approach based on fluency, cognition and health stability. A patient research liaison (PRL) was the sole contact for information regarding the research process, and introduced ongoing studies, screened for eligibility, and completed the consent process(es).
Results
Over five and a half years, 1,561 inpatients with SCI/D were screened for eligibility upon admission, of whom 80% (1256/1561) were deemed suitable for the PRL approach. Of those suitable for the CR process, 80% (1001/1256) agreed to discuss current research opportunities, 46% (235/516) consented to participate in one or more studies, and 86% (856/1001) agreed to future research contact.
Conclusion
This process adhered to ethical procedures and reduced the burden of having multiple researchers approach each individual inpatient regarding research participation, with high consent rates for low-risk studies. Future evaluation of the process scalability is underway.
... Though we were unable to reach our target sample, our study does not suffer from "low enrollment," which is defined as studies that enroll either zero or one participant (Nasser et al., 2011). We currently have sufficient data to begin understanding the cultural landscape of opioid addiction and the barriers and supportive factors of women's treatment experiences. ...
Opioid use disorder among women of childbearing age has reached epidemic proportions. In rural regions of the United States, recruiting perinatal women who use nonmedical opioids to participate in research is wrought with challenges, including barriers such as community stigma, lack of transportation, and time constraints. The current study describes our process and challenges of recruiting pregnant and postpartum women in rural Indiana consisting of women who misuse opioids and those who do not.
We employed multiple strategies to recruit participants. Methods included (1) sampling from healthcare facilities based on referrals from front-desk staff and frontline healthcare workers; (2) dissemination of flyers and brochures within healthcare facilities and the community, supported with onsite research assistant presence; (3) digital methods coupled with snowball sampling; and (4) local community talks that provided information about the study. Our multiple recruitment efforts revealed that building relationships with community stakeholders was key in recruiting women who use nonmedical opioids, but that digital methods were more effective in recruiting a larger sample of pregnant and postpartum women in a short amount of time. We conclude by making several recommendations to enhance academic-community partnerships in order to bolster sample sizes for prolonged research studies. Furthermore, we highlight the need to destigmatize addiction in order to better serve hard-to-reach populations through research and practice.
... The recruitment of research participants is critical to conducting clinical and translational research. Failure in recruiting research participants has a negative financial impact, but, more importantly, under-enrolled studies do not contribute to scientific or clinical knowledge (Nasser et al. 2011). A large number of trials are dependent on the willingness of patients and professionals to give their time and effort to participate. ...
The issue of globalization of research is receiving considerable attention due to the increasing number of offshored R&D activities from the United States, Europe, and Japan. This paper explores this phenomenon and provides a model to analyze the factors that will likely contribute to a global transformation of clinical trials. By identifying the main characteristics of clinical trials, I aim to clarify the main driver of the relocation process of clinical research. I reviewed the relevant published articles to address the research questions. The results of this study challenge the traditional thinking of cost-related factors as the major reason for offshoring cilinical trials and show the importance of the recruitment of human subjects in trials. Consequently, this paper suggests that "recruitment crisis" in home country as the main contribution and a key driver to offshore R&D activities, has been underestimated by previous studies. In particular, this study provides policy-decision makers with a new insight into the development issue surrounding the pharmaceutical industry.
... Recruiting a large enough pool of participants to validate the statistical result of medical research has always been a difficult task for healthcare researchers. More than 81% of clinical trials are delayed because researchers cannot recruit enough participants for the studies (Nasser et al., 2011). In particular, when analyzing 374 cases at Oregon Health & Science University, 31% of clinical research studies enrolled 0-1 subject before being terminated, which creates a waste of over $1 million per year (Kitterman et al., 2011). ...
Significant effort is required to recruit and validate patients for research studies. Researchers are typically limited to patients that they have a physical touchpoint with (e.g., patients at VUMC). This physical access limitation reduces the research attention that patients with rare diseases with little geographic concentration and patients with disadvantaged background in rural areas receive. This paper explores the use of mobile computing and blockchain technology to provide validation of research studies and their data usage, advertisement of research studies, collection of research data, and sharing of data across studies. The paper presents key challenges of using blockchains and mobile computing to solve these issues, competing architectural approaches, and the benefits/trade-offs of each approach.
... Further, they may lack the statistical power necessary to uncover meaningful results and support the conclusions of the study [5]. Thus, understanding how to recruit participants effectively and efficiently is of the utmost importance to ensure successful completion of studies and to advance scientific knowledge [6]. ...
Background:
Ongoing research is necessary to better understand the causes of autism spectrum disorder (ASD), the developmental outcomes for individuals diagnosed with ASD, and the efficacy of the interventions. However, it is often difficult to recruit sufficient numbers of participants for studies, and despite the prevalence of ASD (currently estimated to affect 1 in 54 children), little research has focused on how to efficiently recruit participants with ASD.
Objective:
The aim of this study was to determine the efficacy of two different paid advertisements-social media and radio advertising-in recruiting participants for a study enrolling people with ASD and their family members by examining the number of participants enrolled, the cost per participant, and the geographic reach of each type of advertising.
Methods:
We examined participant enrollment in a study following nonoverlapping paid advertisements on a popular FM radio station (aired in three cities across two states) and Facebook (six advertisements that ran in five cities across two states). The total paid investment in the radio campaign was 2950. Following the advertising campaigns, 1391 participants in the study who were affiliated with the Houston, Texas, site received email invitations to participate in a brief survey about the ways in which they learned about the study (eg, social media, medical provider, website) and which of these were most influential in their decisions to participate; 374 (26.8%) of the participants completed this survey.
Results:
Social media advertising outperformed radio in all three parameters examined by enrolling more participants (338 vs 149), with a lower average cost per participant (80.74) and a wider geographic reach, based on a comparison of the number of zip codes within and outside of Texas for questionnaire respondents who rated social media as the most influential method of contact (n=367, χ21=5.85, P=.02). Of the 374 survey participants, 139 (37.2%) reported that they had seen the study on social media prior to enrollment, while only 9 (2.4%) said they heard about it via radio.
Conclusions:
Our findings suggest that advertising on social media can efficiently reach a large pool of potential participants with ASD, increasing the likelihood of meeting study enrollment goals. Researchers should consider allocating at least some portion of recruitment dollars to social media platforms as a means of quickly and inexpensively reaching out to their target populations, including for studies with in-person procedures.
... As a result of underrecruitment, many studies suffer from a lack of statistical power [6]. This has potential risks: if researchers cannot make their study worthwhile, they waste participants' time and expose them to unnecessary risks without the promise of improvements in clinical care, which is both unproductive and unethical [6,7]. Recruitment challenges also result in considerable additional costs to extend study recruitment periods [8], which may deter funding institutions from supporting clinical trials [6]. ...
Objective:
One of the most challenging parts of running clinical trials is recruiting enough participants. Our objective was to determine which recruitment strategies were effective in reaching specific subgroups.
Study design and setting:
We assessed the efficacy and costs of the recruitment strategies used in the Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study (ACCESS) in Alberta, Canada.
Results:
Twenty percent of the study budget (88 CAD. Pharmacies recruited the most participants (n = 1217), at a cost of 806/enrolled), whereas "word of mouth" and "unpaid media" had the lowest (~$3/enrolled). Participants enrolled from "seniors outreach" had the lowest baseline quality of life and income, while participants from "word of mouth" had the lowest educational attainment.
Conclusion:
The "health care providers" strategies were especially successful - at a moderate cost per enrolled. The "media" strategies were less effective, short lasting, and more costly. No strategy was singularly effective in recruiting our targeted groups, emphasizing the importance of utilizing a variety of strategies to reach recruitment goals.
Trial registration:
ClinicalTrials.gov, NCT02579655 . Registered on 19 October 2015.
... While community collaboration has been high, there are several ways that the academic partners could improve their efforts to ensure successful academic-community collaboration in subsequent scale-up phases. First, the academic partners can play a larger role in educating their community partners about the research process in depth, but in laymen's terms in order to foster understanding of the reasoning for the study design, short and long-term impact, and the vital need for research participants [29]. While the academic partners discussed clinical impact in the 90-minute training sessions, this training may not be adequate when working with EI programs that have little to no prior research experience. ...
Background
Electronic data capture is essential to advancing family-centered coordinated care in early intervention (EI). The purpose of this paper is to report on EI service coordinator response to piloting an electronic parent-reported outcome (e-PRO) assessment as part of their routine workflow, including lessons learned that may inform future phases of e-PRO implementation.
Methods
This second pilot study involved families enrolled in a large EI program (n=1040 families) in concert with their implementation of a statewide quality improvement initiative for care plan development and outcomes reporting. A total of 22 EI service coordinators and supervisors were engaged in 3 phases: initial e-PRO intervention, peer-mentor enhancement, and standard recruitment protocol.
Results
Implementation of the e-PRO intervention and peer-mentoring enhancement yielded low enrollment rates over the first 6 months (n=17). A standard recruitment protocol has resulted in enrollment growth (n=83) towards the targeted enrollment rate (n=832).
Conclusions
This study reports on early insights for building and sustaining a productive academic-community partnership for e-PRO implementation to support family-centered coordinated care. Lessons learned from this academic-community partnership with respect to strategies for enhancing community significance, collaboration, return, and control are discussed as they inform further development of this intervention before scale-up.
... To ensure the success of clinical studies, adequate planning and resources must be invested to determine the feasibility of participant recruitment. 14 We completed this step but underestimated the impact of not having proxies available. Based on this analysis, it may be unrealistic to expect a higher percentage of enrollment within a short window in critical care studies. ...
Background:
Enrollment challenges for critical care research are common. Contributing factors include short enrollment windows, the crisis nature of critical illness, lack of research staff, unavailable legal proxy, family dynamics, and language barriers.
Objective:
To describe enrollment statistics for an ongoing critical care nursing trial, barriers to recruitment, and strategies to enhance enrollment.
Methods:
Two years' worth of recruitment and enrollment data from an oral care intervention trial in critically ill adults receiving mechanical ventilation at 1 hospital were analyzed. Recruitment logs include number of patients screened, eligible, enrolled, and declined and patients' sex, race, and ethnicity.
Results:
Target enrollment (15.5 patients per month) was based on experience and historical data. Strategies implemented to promote enrollment included providing study personnel at least 18 hours per day for 7 days per week, regular rounds, communication with direct care staff, and Spanish consent processes. In 2 years, 6963 patients were screened; 1551 (22%) were eligible. Consent was sought from 366 (24% of eligible patients). Enrollment averaged 13.3 patients per month (86% of projected target). The main factor impeding enrollment was unavailability of a legal proxy to provide consent (88%). The refusal rates of white (11%), black (13%), and Hispanic (16%) patients did not differ significantly. However, those classified as Asian or as more than 1 race declined significantly more often (35%) than did white or black patients (P = .02).
Conclusions:
Unavailability of a legal proxy within a short enrollment window was the major challenge to enrollment. Various factors influenced consent decisions. Clinical study design requires more conservative estimates.
... Participant accrual into research studies is critical to advancing clinical and translational research to clinical care. 1 Clinical research cannot be successful without adequate recruitment and enrollment of human participants. 2 This dilemma is not unique to any one study-type, nor is it confined to academic institutions and/or health centers. 3 More than 80% of clinical trials are delayed as a result of low participant recruitment, and some studies are prematurely terminated. ...
Participant accrual into research studies is critical to advancing clinical and translational research to clinical care. Without sufficient recruitment, the purpose of any research study cannot be realized; yet, low recruitment and enrollment of participants persist. StudySearch is a web-based application designed to provide an easily readable, publicly accessible, and searchable listing of IRB-approved protocols that are accruing study participants. The Regulatory, Recruitment and Biomedical Informatics Cores of the Center for Clinical and Translational Science (CCTS) at The Ohio State University developed this research study posting platform. Postings include basic descriptive information: study title, purpose of the study, eligibility criteria and study personnel contact information. Language concerning benefits and/or inducements is not included; therefore, while IRB approval for a study to be listed on StudySearch is required, IRB approval of the posted language is not. Studies are listed by one of two methods; one automated and one manual: (1). Studies registered on ClinicalTrials.gov are automatically downloaded once a month; or (2). Studies are submitted directly by researchers to the CCTS Regulatory Core staff. In either case, final language is a result of an iterative process between researchers and CCTS staff. Deployed in January 2011 at OSU, this application has grown to approximately 200 studies currently posted and 1500 unique visitors per month. Locally, StudySearch is part of the CCTS recruitment toolkit. Features continue to be modified to better accommodate user behaviors. Nationally, this open source application is available for use.
... In addition, under-enrolled studies waste scarce resources and do not contribute to scientific or clinical knowledge. An analysis conducted at Oregon Health & Science University (OHSU) found that one-third of all studies terminated between 2005 and 2009 at OHSU had low enrollment and these low-enrolling studies cost the institution almost $1 million annually [64]. We found that an intensive population-based approach to recruitment using the California Cancer Registry was the most successful approach, largely because the study team is able to control the pace of recruitment efforts and is not dependent on physician referrals or personnel-intensive in-person recruitment strategies, such attending support groups and community events. ...
Weight loss and metformin are hypothesized to improve breast cancer outcomes; however the joint impacts of these treatments have not been investigated. Reach for Health is a randomized trial using a 2×2 factorial design to investigate the effects of weight loss and metformin on biomarkers associated with breast cancer prognosis among overweight/obese postmenopausal breast cancer survivors. This paper describes the trial recruitment strategies, design, and baseline sample characteristics. Participants were randomized in equal numbers to (1) placebo, (2) metformin, (3) weight loss intervention and placebo, or (4) weight-loss intervention and metformin. The lifestyle intervention was a personalized, telephone-based program targeting a 7% weight-loss in the intervention arm. The metformin dose was 1500 mg/day. The duration of the intervention was 6 months. Main outcomes were biomarkers representing 3 metabolic systems putatively related to breast cancer mortality: glucoregulation, inflammation, and sex hormones. Between August 2011 and May 2015, we randomized 333 breast cancer survivors. Mass mailings from the California Cancer Registry were the most successful recruitment strategy with over 25000 letters sent at a cost of $191 per randomized participant. At baseline, higher levels of obesity were significantly associated with worse sleep disturbance and impairment scores, lower levels of physical activity and higher levels of sedentary behavior, hypertension, hypercholesterolemia, and lower quality of life (p <0.05 for all). These results illustrate the health burden of obesity. Results of this trial will provide mechanistic data on biological pathways and circulating biomarkers associated with lifestyle and pharmacologic interventions to improve breast cancer prognosis.
... Recruitment into clinical and community trials remains a significant challenge for the advancement of cancer research (1)(2)(3). The numbers of racial/ethnic minorities recruited into cancer clinical trials have been, and continue to be, a concern (4-6). ...
Background: Community-based participatory research (CBPR) approaches that involve community and academic partners in activities ranging from protocol design through dissemination of study findings can increase recruitment of medically underserved and underrepresented racial/ethnic minority populations into biomedical research.
Methods: Five cancer screening and prevention trials in three National Cancer Institute (Bethesda, MD)–funded Community Networks Program Centers (CNPC), in Florida, Kansas, and South Carolina, were conducted across diverse populations. Data were collected on total time period of recruitment, ratios of participants enrolled over potential participants approached, selected CBPR strategies, capacity-building development, and systematic procedures for community stakeholder involvement.
Results: Community-engaged approaches used included establishing colearning opportunities, participatory procedures for community–academic involvement, and community and clinical capacity building. A relatively large proportion of individuals identified for recruitment was actually approached (between 50% and 100%). The proportion of subjects who were eligible among all those approached ranged from 25% to more than 70% (in the community setting). Recruitment rates were very high (78%–100% of eligible individuals approached) and the proportion who refused or who were not interested among those approached was very low (5%–11%).
Conclusions: Recruitment strategies used by the CNPCs were associated with low refusal and high enrollment ratios of potential subjects. Adherence to CBPR principles in the spectrum of research activities, from strategic planning to project implementation, has significant potential to increase involvement in biomedical research and improve our ability to make appropriate recommendations for cancer prevention and control programming in underrepresented diverse populations.
Impact: CBPR strategies should be more widely implemented to enhance study recruitment.
See all articles in this CEBP Focus section, “Community Network Program Centers.”
Cancer Epidemiol Biomarkers Prev; 23(3); 416–23. ©2014 AACR.
... However, informed consents are fraught with readability and comprehension issues (
1
–
3
) and recruitment of adequate numbers of research participants is often problematic. Failure to recruit an adequate number in a reasonable time frame increases the cost of studies (
4
) and reduces statistical power due to smaller sample size. One mechanism to increase participation in research is to solicit patients’ general willingness to participate in clinical research. ...
Informed consents are a critical and essential component of the clinical research process. Currently, most consents and research privacy authorizations are being captured on paper. In this paper we describe a novel method of capturing this information electronically. The objective is to allow easier tracking of research participants' intent for current and future research involvement, enhance consent comprehension and facilitate the research workflow. After multidisciplinary analysis in key hospital registration areas and research participant enrollment, an open source software product was designed to capture this data through a user-friendly touch screen interface. The data may then be fed into a clinical data warehouse for use in cohort discovery or consent tracking. Despite ethical, legal and informatics challenges in clinical and research environments, we propose that this technology opens new avenues for significantly enhancing the consent process and positively impacting recruitment.
... Recruitment of research participants is critical to the conduct of clinical and translational research; however , clinical research often is hindered by difficulties in recruiting adequate numbers of participants. Failure to recruit an adequate number of participants in a reasonable time frame increases the cost of studies [1], can reduce the power of the study to find important effects of interventions [2], and may reduce the usefulness of the study findings if standards of care change during conduct of the study or may lead to failure to complete the study [3,4]. There are a number of potential reasons for poor research recruitment. ...
Background:
One mechanism to increase participation in research is to solicit potential research participants' general willingness to be recruited into clinical trials. Such research permissions and consents typically are collected on paper upon patient registration. We describe a novel method of capturing this information electronically.
Purpose:
The objective is to enable the collection of research permissions and informed consent data electronically to permit tracking of potential research participants' interest in current and future research involvement and to provide a foundation for facilitating the research workflow.
Methods:
The project involved systematic analysis focused on key areas, including existing business practices, registration processes, and permission collection workflows, and ascertaining best practices for presenting consent information to users via tablet technology and capturing permissions data. Analysis was followed by an iterative software development cycle with feedback from subject matter experts and users.
Results:
An initial version of the software was piloted at one institution in South Carolina for a period of 1 year, during which consents and permission were collected during 2524 registrations of patients. The captured research permission data were transmitted to a clinical data warehouse. The software was later released as an open-source package that can be adopted for use by other institutions.
Limitations:
There are significant ethical, legal, and informatics challenges that must be addressed at an institution to deploy such a system. We have not yet assessed the long-term impact of the system on recruitment of patients to clinical trials.
Conclusions:
We propose that by improving the ability to track willing potential research participants, we can improve recruitment into clinical trials and, in the process, improve patient education by introducing multimedia to informed consent documents.
... Galbreath et al. 7 described factors for successful recruitment of subjects: securing key study personnel in charge of the research; provision of an educational program to increase understanding of the clinical trial process; and allocating sufficient time. Nasser et al. 10 stated that access to an adequate number of persons who fit the study inclusion criteria and professional and intensive recruitment process are two key factors to improve subject participation. UyBico et al. 8 reported that although promotion is effective in recruiting subjects, efficiency is questionable due to the cost and low enrollment rate. ...
The purpose of this study was to evaluate the effectiveness of a promotion campaign for subject recruitment and selection, and reasons of withdrawal from a prospective clinical trial of mandibular two-implant supported overdenture.
The subjects of this study were participants in a randomized controlled clinical trial for investigating prognosis of implants and overdentures with attachments. Recruited subjects were classified by gender, age, and participation motives. Withdrawal rate of the participants before and after enrollment were evaluated.
177 patients were recruited and 51 patients were enrolled for the trial. Among them, 40 participants eventually took part in the trial. 116 subjects (65.5%) were recruited by advertisement and 61 (34.5%) were referred by patients of the hospital or local clinics. Regarding recruitment effectiveness, newspaper recruited the largest number of participants. With respect to referral patients, the proportion of our hospital patients was higher (37/61). Subjects in their 70s comprised the largest proportion (22/51). The male to female ratio was similar (25:26). Final withdrawal rate of all subjects were 74.0%. Among the reasons for withdrawal from enrollment (n=126) presence of remaining teeth and lack of motivation were the most common reasons.
To facilitate recruitment of clinical trial subjects and improve enrollment rate, it is important to obtain a sufficient number of researchers, perform promotion activity with diverse strategies, cooperate with local dentists, increase the research funding, and alleviate subjects' fear against clinical trials by thorough consultation.
Empirische klinische Studien stellen die Grundlage der evidenzbasierten Medizin dar. Ihre erfolgreiche Durchführung hängt dabei auch von der Rekrutierung einer passenden Anzahl von Probanden ab, denn nur so können statistisch haltbare Aussagen über die untersuchte Behandlung getroffen werden. Dennoch stellen nicht oder nur durch Verlängerung der Laufzeit erreichte Probandenzahlen ein oft-berichtetes Problem dar. Sowohl die Anzahl als auch die inhaltliche und regulatorische Komplexität klinischer Studien wächst kontinuierlich. Entsprechend ist es notwendig zu prüfen ob und in welchem Maße Aspekte ihrer Durchführung dabei durch IT-Systeme optimiert und unterstützt werden können. Dies wurde im Rahmen der dieser Dissertation zugrunde liegenden Teilprojekte getan. Eine wichtige Grundlage sind dabei die Ergebnisse einer Stakeholderanalyse, in welcher der Status Quo der IT-Unterstützung im Rahmen der Patientenrekrutierung an deutschen Universitätskliniken sowie Anforderungen an diese erfasst wurden. Studienregister bieten sowohl für Patienten als auch für medizinisches Personal einen wichtigen Anlaufpunkt, um sich über aktuelle klinische Studien zu informieren. Ein Teilergebnis dieser Arbeit ist die neuartige Nutzung von Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) um den Austausch und das Aktuell-halten von Daten in diesen Registern zu standardisieren. Eine weitere Arbeit beschreibt, wie Informationen über klinische Studien kompakt dargestellt werden können: verschiedene Verfahren der automatischen Text-Zusammenfassung wurden verglichen um ohne Informationsverlust lange Studienbeschreibungen zu kürzen. Ziel ist es die Zeit zu reduzieren die eine interessierte Person investieren muss um sich mit den Kerninformationen einer klinischen Studie vertraut zu machen. Einer der wichtigsten Inhalte eines Studienprotokolls sind die Ein- und Ausschlusskriterien: sie beschreiben die Patientenkohorte, die für eine Teilnahme geeignet ist. Sie stellen also die Grundlage für eine automatisierte Suche nach passenden Probanden auf Basis der Patientendaten dar. Um zu identifizieren, welche Datenelemente typischerweise in diesen Kriterien abgefragt werden, wurden in einem Teilprojekt aus den Ein- und Ausschlusskriterien von 50 Studienprotokollen strukturierte Datenelemente extrahiert und deren Häufigkeiten analysiert. Darauf aufbauend wurde das Vorhandensein dieser Datenelemente in elektronischen Patientenakten im Rahmen einer Datenqualitätsstudie an 10 Universitätskliniken in Deutschland geprüft. Eine weitere Teilarbeit beschäftigt sich damit, wie solche Ein- und Ausschlusskriterien als FHIR Suchabfragen formalisiert werden können, um in strukturierten Patientendaten geeignete Studienkandidaten zu identifizieren. Damit diese Daten möglichst vollständig sind, wurde in einer weiteren Arbeit ein Werkzeug umgesetzt, das aus Freitext-Informationen wie Arztbriefen strukturierte klinische Merkmale repräsentiert als FHIR-Format extrahiert.
Introduction:
The rising burden of liver disease requires new treatment approaches. Clinical trials are one way forward. However, many patients are unaware that they may be eligible to enter a clinical trial.
Methods:
A survey was designed to determine if patients with liver disease were aware of opportunities to partake in trials. It was distributed to patients attending the University Hospitals Birmingham liver outpatient department over a 2-week period and to patients who had viral hepatitis. The data were collected and analysed.
Results:
The majority of respondents were White, male, and aged 45–64 years. A number of demographic trends in the frequency of invitations to, requests for and awareness of clinical trials were reported. Patients reported that health professionals were their predominant source of information about clinical trials.
Discussion:
While some patients expressed an interest in trials, a significant proportion had not been asked to take part, and a more detailed project is needed to determine why this is.
Objectives:
Recruitment strategies usually focused on a single International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code and rarely included exclusion criteria. The purpose of this study was to validate a claims-based algorithm to identify, from Veterans Affairs administrative data, eligible participants to be recruited into a hypertension trial.
Study design:
Cross-sectional.
Methods:
Subjects were labeled as eligible if they were 75 years or older, had a hypertension ICD-9-CM code (401.x-405.x, 437.2) and did not have a diabetes (250.xx) or stroke (430.x-436.x, 437.1, 437.9, 438.x) ICD-9-CM code. We compared the eligible subjects with the medical record-which was considered the gold standard-and we calculated the positive predictive value (PPV) of identifying a subject in the medical record.
Results:
The algorithm identified 3591 elderly veterans with hypertension with no diabetes or stroke, and we reviewed the medical records of 76 randomly selected patients. In the sample of medical record review, the mean age in years was 83 ± 5.3, 48% had coronary artery disease, and the mean systolic blood pressure was 134 mm Hg ± 15.5. When compared with the medical record, the PPV for any hypertension code was 93% (95% CI, 85%-98%), and for the entire algorithm, including 75 years or older and the absence of both diabetes and stroke, the PPV was 83% (95% CI, 73%-91%).
Conclusions:
The use of any ICD-9-CM code for hypertension is useful to identify elderly patients with hypertension. The algorithm to identify elderly patients with hypertension and without diabetes or stroke is a useful tool to also identify eligible patients for clinical trial participation.
AimThe aim of this study was to describe nurse leaders’ perceptions of ethical recruitment in clinical research.Background
Nurse leaders are expected to get involved in clinical research, but there are few studies that focus on their role, particularly the ethical issues.Method
Qualitative data were collected from ten nurse leaders using thematic one-to-one interviews and analysed with content analysis.ResultsNurse leaders considered clinical research at their workplace in relation to the key issues that enabled ethical recruitment of study subjects in clinical research. These were: early information and collaboration for incorporating clinical research in everyday work, an opportune and peaceful recruitment moment and positive research culture.Conclusion
Getting involved in clinical research is part of the nurse leader's professional responsibility in current health care. They have an essential role to play in ensuring that recruitment is ethical and that the dignity of study subjects is maintained.Implications for nursing managementThe duty of nurse leaders is to maintain good contact with other collaborators and to ensure good conditions for implementing clinical research at their site. This requires a comprehensive understanding of the overall situation on their wards. Implementing clinical research requires careful planning, together with educating, supporting and motivating nursing staff.
Unlabelled:
Improving patient recruitment and consent to participate in clinical studies is an important issue. The process of consent involves three steps: patient referral for contact, the preliminary interview to determine patient interest, and the informed consent discussion. We hypothesized that putting the first step of the consent process into a 'Permission to Contact' (PTC) platform would improve patient engagement, would improve the efficiency of the other steps of the process, and would be acceptable to diverse patient groups.
Methods:
To test this hypothesis, four PTC platforms were established in three types of outpatient health clinics (cancer, cardiac, maternal health) in different British Columbia health centers. Each began as a research project where clinic personnel were engaged, clinic flow processes were mapped, and a design for each PTC was derived by consensus. All patients at these clinics were asked for 'permission to be contacted for future research purposes.' Patient approach and permission response rates were assessed and operational costs were estimated.
Results:
Overall permission rates were high for all projects, but ranged from 94% of 'cancer' patients to 80% of 'congenital heart' patients who were approached (p<0.0001). Sustainability was demonstrated by stable enrollment levels after several years, and ongoing costs averaged 12-$39) for each 'permission' across all four platforms.
Conclusions:
A PTC platform is a feasible mechanism to engage patients in research programs such as biobanking. It is well supported by clinic staff and receives high engagement and acceptance from patients. Patient-approach rates vary in different clinics, likely due to both clinic and PTC process factors, but this strategy provides an efficient means of engaging patients in research and sets the stage for enhanced enrollment into translational research programs.
Objective:
A pilot study to examine accrual rates, efficiency of data capture approaches, study design and genotyping capacity for a future genetic validation study was undertaken.
Design:
The process pilot evaluated feasibility of applying a matched case-control design to validate association of two candidate estrogen receptor (ER) single nucleotide polymorphisms (SNPs) with incidence of venothromboembolic events (VTE) in breast cancer patients treated with tamoxifen where criteria included frequency matching by age, number of years diagnosed with breast cancer within 4-year intervals, and geographic residency.
Setting:
The study was conducted at Marshfield Clinic, in central Wisconsin.
Participants:
Study-eligible cases with a breast cancer diagnosis between 1994 and 2006 who experienced a VTE within 5 years of last tamoxifen exposure were matched at a ratio of 1:4 to controls with a breast cancer diagnosed between 1994 and 2006 with no VTE history following tamoxifen exposure for ≥2 years.
Methods:
Feasibility of enrolling, phenotyping, and genotyping 20% of the total number of validated eligible cases and controls was tested in order to project enrollment rates and assess probability of enrolling the projected sample size for the prospective validation study and adequacy of planned data capture. Conditional logistic regression analysis was conducted for the matched case-control study design.
Results:
Enrollment accruals included 19 of 24 targeted cases (79%), and 74 of 96 (77%) targeted controls. Electronic data capture for most variables was nearly 100%. No unexpected statistically significant differences were observed between cases and controls. Capacity to conduct in-house screening for rs2234689 (ER1 PvuII), rs9340799 (ER1 XbaI), rs13146272 (CYP4V2), rs2227589 (SERPINC 1) and rs1613662 (GP6) was successfully established. Association of GP6 with VTE was further validated (P=0.0403; OR, 0.19).
Conclusion:
Accrual rates to the larger prospective study will require a multi-center design to ensure enrollment of adequate numbers of cases and controls for achieving the projected sample size required to validate association of the ER SNPs. To prevent study failure due to poor accrual, the importance of conducting feasibility studies before launching large scale validation studies of genetic association and adverse drug events, is discussed.
The authors assessed the prevalence and associated economic impact of low-enrolling clinical studies at a single academic medical center.
The authors examined all clinical studies receiving institutional review board (IRB) review between FY2006 and FY2009 at Oregon Health & Science University (OHSU) for recruitment performance and analyzed them by type of IRB review (full-board, exempt, expedited), funding mechanism, and academic unit. A low-enrolling study included those with zero or one participant at the time of study termination. The authors calculated the costs associated with IRB review, financial setup, contract negotiation, and department study start-up activities and the total economic impact on OHSU of low-enrolling studies for FY2009.
A total of 837 clinical studies were terminated during the study period, 260 (31.1%) of which were low-enrolling. A greater proportion of low-enrolling studies were government funded than industry funded (P=.006). The authors found significant differences among the various academic units with respect to percentages of low-enrolling studies (from 10% to 67%). The uncompensated economic impact of low-enrolling studies was conservatively estimated to be nearly $1 million for FY2009.
A substantial proportion of clinical studies incurred high institutional and departmental expense but resulted in little scientific benefit. Although a certain percentage of low-enrolling studies can be expected in any research organization, the overall number of such studies must be managed to reduce the aggregate costs of conducting research and to maximize research opportunities. Effective, proactive interventions are needed to address the prevalence and impact of low enrollment.
The Gift of Participation: A Guide to Making Informed Decisions About Volunteering for a Clinical Trial Bar Harbor, ME: Jerian Publishing Nasser et al. Page 3
- K Getz
Getz, K. The Gift of Participation: A Guide to Making Informed Decisions About Volunteering for a Clinical Trial. Bar Harbor, ME: Jerian Publishing; 2007. Nasser et al. Page 3 Acad Med. Author manuscript; available in PMC 2012 November 1. NIH-PA Author Manuscript NIH-PA Author Manuscript NIH-PA Author Manuscript
Accessed April 27 Accelerating clinical trials: Budgets, patient recruitment, and productivity. Cutting Edge Information
- J Hess
Hess, J. [Accessed April 27, 2011] Accelerating clinical trials: Budgets, patient recruitment, and productivity. Cutting Edge Information. Research Report. November 21. 2004 Available at: www.AcceleratedClinicalTrials.co
Recruitment and retention in clinical trials: What works, what doesn't and why. Presented at: 2006 Drug Information Association Annual Summit
- C Pierre
Pierre, C. Recruitment and retention in clinical trials: What works, what doesn't and why. Presented
at: 2006 Drug Information Association Annual Summit; June 2006; Philadelphia, PA.