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Barriers and facilitators to participation of minorities in clinical trials
Abstract
Historically, researchers have experienced difficulties with the recruitment of underrepresented populations, especially for women and minorities to cancer clinical trials. This has lead to marked health disparities among these groups. The purpose of this literature review is to investigate barriers and facilitators that provide explanations for the low participation rate of women and minorities in clinical trials.
A search was conducted for published work in medical and social research from 1995 to 2008 using computerized databases: PubMed, CINAHL, and PsyclNFO. The following MeSH terms were used; clinical trials, minorities, minority groups, participation, recruitment, research subjects, and neoplasm. This netted a total of 43 articles, 22 of which were deemed appropriate for this article.
Most striking throughout the literature was that barriers to trial participation were reported at an appreciably higher rate than facilitators. Health care provider barriers were captured by two themes: physician triage and physician knowledge. Patient barriers to trial participation emerged as reports of fear, mistrust of the medical community and the burden associated with trial participation. Facilitators to trial participation included physician enthusiasm and good communication skills, a good provider-patient relationship, having a perceived benefit, and feelings of altruism.
This review provides a background into women and minorities' participation in clinical research. Patient recruitment into clinical trials is a complex process and there is limited research exploring the optimization of study recruitment.
More information is needed to understand the issues surrounding the decision making process of the potential trial participant.
... There is also evidence that racial and ethnic minority individuals feel inadequately compensated (70). Patients are also reluctant to participate in studies out of fear of losing confidentiality and privacy (74)(75)(76). Despite the process of informed consent, deep-rooted distrust of researchers among racial and ethnic minority individuals persist, as well as a fear of what will happen to their personal information (68). ...
... If providers are unable to articulate the potential benefits of a trial in a way the patient can understand while also being able to answer relevant questions about the trial, it is unlikely Frontiers in Public Health 07 frontiersin.org that they will introduce the patients to research opportunities (69,70,74,(82)(83)(84). Also, the increasing number of expectations and burnout experienced by providers limits their time and willingness to introduce research participation to their patients (85). ...
... Sponsor/system-level barriers include lack of transportation, which precludes the inclusion of potential participants with an inability to reach the health care facilities or research facilities (69,70,74,76,82). Previous studies have shown that Hispanic/Latino patients tend to have less access to transportation compared to non-Hispanic White individuals and often cite it as a barrier to care (86). ...
Type 2 diabetes (T2D) affects millions of individuals worldwide and is a well-documented risk factor for cardiovascular (CV) disease and chronic kidney disease, both of which are leading causes of mortality. Racial and ethnic minority groups in the US, including but not limited to Hispanic/Latino, non-Hispanic Black, and Southeast Asian individuals, are disproportionately burdened by both T2D and its adverse outcomes. In recent years, there have been numerous cardiovascular outcomes trials (CVOTs) on novel antidiabetic therapies, including the dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), and sodium-glucose cotransporter-2 (SGLT2) inhibitors. CVOTs’s initial aim was to demonstrate the cardiovascular safety of these drugs. Unexpected CV and kidney protective effects were found, specifically among the GLP-1 RAs and the SGLT2 inhibitors. These benefits informed the new paradigm of the management of patients with T2D. However, some experts argued that the lack of racial and ethnic minority group representation in these trials represented a challenge. While the downstream effects of this lack of representation must be further elucidated, it is clear and recognized that efforts need to be made to include a more representative sample in future CVOTs, specifically including individuals from those groups most burdened by T2D and its complications, if clinicians are to have an accurate picture of the benefits and potential pitfalls of utilizing these drugs in a real-world setting. In this comprehensive review, we briefly summarize the significant findings from the CVOTs, report the lack of representation of Hispanic/Latino, non-Hispanic Black, and Southeast Asian individuals in the CVOTs, investigate the barriers to recruiting racial and ethnic minority groups into clinical trials, and suggest potential solutions to overcome these obstacles at the patient-, provider-, and sponsor/system-level in future trials.
... The CAB, supported by the research team, designed the study, determined the number of participants, contributed to developing the focus group discussion guidelines and vignettes, and led the focus group discussions. The CAB's presence allowed participants to feel comfortable with the researchers given research mistrust within Muslim communities (Killawi et al., 2015;Schmotzer, 2012). ...
This qualitative study examines perceptions of Muslims living in the San Francisco Bay Area, California, United States, regarding the family’s role in mental health help-seeking and well-being. This study employed a community-based participatory research approach through content analysis of three focus group (n = 37) discussions conducted with the help of a community advisory board comprised San Francisco Bay Area Muslim community members. Four main themes were generated. (1) Participants stated that Muslim American families play a unique role, via socioreligious norms and cultural expectations, in mental health quality and help-seeking. (2) The types of familial mental wellness support depend on the capacity of family members relative to their roles and influence in the family. (3) Families are responsible for referring individuals to external support, especially when the problem is beyond familial capacity. (4) The family is a potential source of mental health-related challenges. Participants noted the need for family-wide interventions led by mental health professionals or religious/community leaders. These findings stress the need for increased attention to and engagement of families in providing psychiatric care for Muslim Americans, specifically those living in the Bay Area, California, United States. Special attention should be placed on mental health barriers and challenges the family may create for an individual.
... Socioeconomic status (SES) also influences participation in clinical trials. Individuals with lower SES often have financial barriers, such as the inability to take paid time off from work or lack of childcare, which can impact their ability and willingness to participate [23,24]. Moreover, individuals from lower SES groups may lack health insurance, further restricting their access to healthcare and participation in clinical trials [24]. ...
Background: There is significant underrepresentation in clinical trials across diverse populations. Less is known about how health system-related factors, such as relationships and trust, mediate the motivation for clinical trial participation. We aimed to investigate whether health system-related factors explain the association between sociodemographic factors and motivation for participation. Additionally, we explored whether the mediating effects differ by gender. Methods: We used the Health Information National Trends Survey 2020 cycle-4 data. Motivation for clinical trial participation, assessed through eight items, was the outcome variable (range 1–4). Predictors included age, race, ethnicity, education, general health, and depression. The health system-related explanatory variables were health information distrust, having a regular provider, and the frequency of healthcare visits. Gender was the moderator. A structural equation model (SEM) was used for the overall and gender-stratified analyses. Results: Among the 3865 participants (mean [SE] age of 48.4 [0.53] years, 51.4% women, and 24.3% non-White), older age (β = −0.170; p < 0.001) and non-White race (β = −0.078; p < 0.01) were negatively associated, and higher education (β = 0.117; p < 0.001) was positively associated with motivation. Higher distrust (β = −0.094; p < 0.01) decreased motivation, whereas having a regular provider increased motivation (β = 0.087; p < 0.01). The gender-stratified SEM revealed that women, but not men, with higher distrust showed lower motivation (β = −0.121; p < 0.01), and men, but not women, with a regular healthcare provider showed higher motivation (β = 0.116; p < 0.01). Conclusions: Our study found that women with higher distrust showed lower motivation, while men with a regular healthcare provider demonstrated higher motivation. These gender differences highlight the need for tailored recruitment approaches that account for their distinct relationships with the health system.
... The literature on barriers to minority participation in clinical trials is substantial. These barriers primarily revolve around themes of distrust, lack of interest or awareness in clinical trial participation opportunities, ineffective communication of research findings, and a perceived absence of respect from study team members [10][11][12][13][14][15]. Conversely, a positive relationship with healthcare providers and an altruistic outlook are frequently cited as motivators for participation. ...
Objective
To enhance recruitment and participation rates of non-Hispanic Black (NHB) and Hispanic adult patients in a NIH-funded clinical trial studying an emerging health technology.
Data Sources and Study Setting
This study includes primary data collected in Los Angeles, California from November 2020 through November 2023.
Study Design
To improve the representation of NHB and Hispanic patients in a NIH-funded (NCT04409353) trial on virtual reality for chronic lower back pain (cLBP), we conducted a multi-phase study utilizing a mixed-method approach. First, we conducted focus groups with NHB and Hispanic cohorts aged 18 and older; based on the feedback, we culturally adapted recruitment materials and study correspondences concordantly. Additionally, a cohort builder was used to filter the electronic medical record to isolate non-Hispanic Black (NHB) and Hispanic patients with cLBP for micro-targeted recruitment. These changes were collectively integrated when the parent NIH study had recruited 222 of its 385 final samples (57.7%), creating a pre-post comparison timepoint (May 17, 2022). Quantitative analysis was performed to assess the efficacy of the modified recruitment strategies by comparing the number of recruited and randomized NHB and Hispanic patients pre- and post-intervention.
Data Collection/Extraction Methods
Semi-structured focus groups were conducted with NHB and Hispanic patients and community members (age 18 and older). The focus groups were conducted online and recorded with participant consent; transcripts of the recording underwent inductive thematic analysis. Emergent themes directed the modification of study materials, including revised language and imagery, targeted outreach, and incorporation of treating physicians, were implemented in the second half of the study. Quantitative analyses were conducted following parent study completion by comparing records added to the screening database following the implementation of new recruiting methods (5/17/2022) to those added before.
Principal Findings
Thematic analysis of focus groups identified four key themes: mistrust, lack of interest, culture, and communication. Modifications to recruitment methodology resulted in statistically significant increases in the pre- to post-randomization success rate for the overall study population ( p < 0.001), the NHB population ( p = 0.011), and the Hispanic population ( p < 0.015). When looking at each cohort at different points in the recruitment process before and after the intervention, in the Hispanic population, we saw significant increases in the number approached ( p < 0.001) and number randomized ( p < 0.001) and statistically insignificant increases in the NHB population approached ( p = 0.067) and randomized ( p = 0.295). Similarly, we saw that the changes in the recruitment letter led to a statistically significant increase in Hispanic recruitment (7.0 to 39.1%, p < 0.001) but not the NHB cohort (19.6 to 35.8%, p < 0.065).
Conclusion
This study introduces several culturally sensitive considerations and possible approaches for the design of recruitment materials, addressing mistrust, lack of interest, culture, and communication for use in NHB and Hispanic populations. Similarly, the described microtargeting techniques leverage the technological advancements in cohort building to improve the reach and efficiency of the randomization rate of underrepresented groups thereby enhancing clinical trial diversity.
... Our study findings are also consistent with other research highlighting that the potential benefits of participation are less likely to resonate with Black patients, including the notion that participation is a benefit to their community. One factor is a higher level of level of general medical mistrust found in the Black/African American community [75], which is associated with expectations of lower care quality and poorer treatment experiences [76]. ...
Background
Black/African American adults are underrepresented in oncology clinical trials in the United States, despite efforts at narrowing this disparity.
Objective
This study aims to explore differences in how Black/African American oncology patients perceive clinical trials to improve support for the clinical trial participation decision-making process.
Methods
As part of a larger randomized controlled trial, a total of 244 adult oncology patients receiving active treatment or follow-up care completed a cross-sectional baseline survey on sociodemographic characteristics, clinical trial knowledge, health literacy, perceptions of cancer clinical trials, patient activation, patient advocacy, health care self-efficacy, decisional conflict, and clinical trial intentions. Self-reported race was dichotomized into Black/African American and non–Black/African American. As appropriate, 2-tailed t tests and chi-square tests of independence were used to examine differences between groups.
Results
Black/African American participants had lower clinical trial knowledge (P=.006), lower health literacy (P<.001), and more medical mistrust (all P values <.05) than non–Black/African American participants. While intentions to participate in a clinical trial, if offered, did not vary between Black/African American and non–Black/African American participants, Black/African American participants indicated lower awareness of clinical trials, fewer benefits of clinical trials, and more uncertainty around clinical trial decision-making (all P values <.05). There were no differences for other variables.
Conclusions
Despite no significant differences in intent to participate in a clinical trial if offered and high overall trust in individual health care providers among both groups, beliefs persist about barriers to and benefits of clinical trial participation among Black/African American patients. Findings highlight specific ways that education and resources about clinical trials could be tailored to better suit the informational and decision-making needs and preferences of Black/African American oncology patients.
... Studies suggest that the language spoken by patients and research professionals may be more important of a factor in enrollment than race [15][16][17], not only that a patient's primary language influenced enrollment success, but research professionals had more success enrolling subjects who shared their primary language ("language concordance") [15] Further, a majority indicated that the language barrier and time spent arranging for interpreters had prevented them from offering a study to potential candidates [15,16]. While it might be intuitive that a CT investigator being the same race and/or ethnicity as a potential study subject ("racial concordance") might appear to be motivating to minorities' participation studies show that race and ethnicity of potential candidates did not always indicate they were more successful in enrolling subjects of their own race for various reasons [15,[18][19][20][21]. While it is highly unlikely to have research professionals speak every patient language without interpreter services, multicultural research staff may improve representation in CT enrollment by potentially having more positive attitudes related to cultural differences among potential participants. ...
Background
To explore the association between ethnicity, as a proxy for language, and participation in clinical trials (CT) conducted by Principal Investigators (PI) who speak one or more language in addition to English.
Methods
This retrospective, descriptive study utilized CT participant demographic data extracted from the largest Midwestern non-profit healthcare system between January 1, 2019 and 12/31/2021. The CT participant sample (N = 4308) was divided for comparison: CT Participants of Hispanic or Latino Origin (N = 254; 5.90 %) and CT Participants of Non-Hispanic or Latino Origin (N = 4054; 94.10 %). Logistic regressions were performed to generate the crude and adjusted odds of patients of Hispanic or Latino origin participating in CTs conducted by PIs who speak another language in addition to English.
Results
Crude analysis revealed that patients of Hispanic or Latino ethnicity had 2.04 (1.58, 2.64) times greater odds of participating in CTs conducted by PIs who speak another language than English (<0.0001), which increased to 2.67 (1.97, 3.62) times greater odds after adjusting for sex, race, age and insurance (p < 0.0001).
Conclusions
Overall findings indicate that patients of Hispanic or Latino ethnicity, who are more likely to speak Spanish, have greater odds of participating in CTs conducted by PIs who speak another language beyond English. This may imply that cultural sensitivity at the top of a CT study team, as likely to be demonstrated by PIs who speak another language beyond English, may be an important contributor to reducing ethnicity- and language-based barriers to diversity in CTs and a relationship worth exploring further.
... Both AAPI and Black participants stressed the need for research studies to connect families directly to valued local resources, such as intervention and social-skills groups and to provide them with new information relevant to their children with autism, such as a research summary or report. Referrals to community resources from researchers may play a pivotal role in facilitating participation in genetic research among racial minorities, which has been the case in clinical trials (Schmotzer 2012). While genetic research is important to advance our understanding of autism, the implications of such participation may still seem distant to participants. ...
Genetic research can help advance our knowledge of autism and positively impact the progress of care for individuals with autism. Asian American and Pacific Islander (AAPI) and Black participants remain significantly underrepresented in genetic research in autism in the United States, including nationwide, multisite, genetic consortiums like Simons Foundation Powering Autism Research for Knowledge (SPARK). Few studies have explored the unique motivators and barriers that influence participation in genetics research across underrepresented groups with autism and strategies to increase participation. Therefore, the aim of this study was to understand the perspectives of AAPI and Black parents of individuals with autism about participating in genetic research, specifically motivators (e.g., desire to know more about the relationship between autism and genetics) and/or barriers (e.g., mistrust of research staff) that may impact their decision to participate in genetic research. Using a mixed-methods approach, we collected surveys (n = 134) across the United States and conducted three focus groups with parents of individuals with autism (n = 16) who identified as AAPI and Black from two large metropolitan cities. No significant differences were observed in the survey data but findings from the focus groups elucidate shared motivators for participation (e.g., to help advance the autism field for future generations) and nuanced differences in barriers that influence Black and AAPI parents’ decision to participate (e.g., different beliefs about the source of autism). Practical suggestions to improve outreach and study engagement in genetic research in autism were identified and discussed.
Objectives
To explore the perspectives of Māori and Pacific women who participated in the Fish Oil study to ascertain what barriers and facilitators may exist for successfully recruiting Māori and Pacific women into clinical trials.
Design
A Kaupapa Māori qualitative study.
Setting
Auckland, New Zealand.
Participants
16 Māori and Pacific women who participated in the fish oil supplementation during pregnancy study (ACTRN12617001078347p) between 1 January 2017 and 31 December 2020.
Main outcome measures
Semistructured in-depth interviews were conducted, recorded and transcribed and then subjected to inductive thematic analysis to identify key themes related to barriers and facilitators of successful Māori and Pacific women recruitment into a clinical trial.
Results
Of 37 eligible Māori and Pacific women who participated in the original Fish Oil study, 16 women consented to participate in this study. Three key themes were identified: (1) relationships matter, (2) privileges and barriers and (3) the study experience. Key facilitators for recruitment included having solid relationships with research team members, practising exemplary professionalism, having clear communication and having the ability to establish rapport and research team flexibility. The desire to create a better future for participants’ babies and to give back to Māori and Pacific communities through participating in a clinical trial were also key drivers of successful recruitment. In contrast, the major barriers described were time pressures and the distance to the research facility.
Conclusions
Sixteen Māori and Pacific women who participated in a double-blinded randomised controlled trial shared that successful recruitment of Māori and Pacific women into clinical trials can be promoted by research flexibility participants’ whānau/family responsibilities, effective and culturally safe communication, and research teams striving to build and maintain relationships with participants throughout the trial.
Trial registeration number
Australian New Zealand Clinical Trials Registry, ACTRN12617001078347p. Universal Trial Number (U1111-1199-5860).
Background
Racial and ethnic minorities remain underrepresented in gynecologic cancer clinical trials despite disproportionately worse oncologic outcomes. Research shows differential racial enrollment patterns due to comorbidity-based exclusion criteria (CEC). Our objective was to evaluate contemporary trends in CECs among NCI-sponsored gynecologic cancer clinical trials and protocol adherence to broadened eligibility criteria guidelines as an assessment of equitable enrollment access.
Methods
The ClinicalTrials.gov registry was queried for NCI-sponsored gynecologic cancer clinical trials (1994-2021). Study characteristics and CECs were abstracted from protocols. Descriptive statistics and temporal trends were calculated using chi-square testing with STATA v17 software.
Results
Among 279 clinical trials identified, 65% completed enrollment, 53% were Phase II, and 48% focused on ovarian cancer. Pharmaceutical agents (85%) were the primary therapeutic interventions.
Several inequitably restrictive exclusion criteria increased over time such as hepatitis infection (17% in 1994-2000 vs 49% in 2015-2021, p < .001) and cardiovascular disease (47% in 1994-2000 vs 66% in 2015-2021, p = .002). A previously rare exclusion, “mental illness/social situations,” dramatically increased from 5% to 51% (p < .001) over three decades.
Adherence to broadened eligibility criteria recommendations was mixed. Renal function, cardiovascular disease, and performance status criteria were not broadened but HIV, prior/concurrent malignancies, and brain metastasis criteria were.
Conclusions
Some, but not all, of the known restrictive CECs have increased in gynecologic cancer clinical trial design, despite calls for improving racial and ethnic minority representation. While exclusion criteria are critical for trial safety, they must be carefully considered given the differential racial impact on eligibility.
Early detection of Alzheimer’s disease (AD) is crucial to maximize clinical outcomes. Most disease progression analyses include people with diagnoses of cognitive impairment, limiting understanding of AD risk among those with normal cognition. The objective was to establish AD progression models through a deep learning approach to analyze heterogeneous, multi-modal datasets, including clustering analyses of population subsets. A multi-head deep-learning architecture was built to process and learn from biomedical and imaging data from the National Alzheimer’s Coordinating Center. Shapley additive explanation algorithms for feature importance ranking and pairwise correlation analysis were used to identify predictors of disease progression. Four primary disease progression clusters (slow, moderate and rapid converters or non-converters) were subdivided into groups by race and sex, yielding 16 sub-clusters of participants with distinct progression patterns. A multi-head and early-fusion convolutional neural network achieved the most competitive performance and demonstrated superiority over a single-head deep learning architecture and conventional tree-based machine-learning methods, with 97% test accuracy, 96% F1 score and 0.19 root mean square error. From 447 features, 2 sets of 100 predictors of disease progression were extracted. Feature importance ranking, correlation analysis and descriptive statistics further enriched cluster analysis and validation of the heterogeneity of risk factors.
Supplementary Information
The online version contains supplementary material available at 10.1038/s41598-024-77829-1.
Few interventions have been designed and tested to improve recruitment to clinical trials in oncology. The multiple factors influencing patients' decisions have made the prioritization of specific interventions challenging. The present study was undertaken to identify the independent predictors of a cancer patient's decision to enter a randomized clinical trial.
A list of factors from the medical literature was augmented with a series of focus groups involving cancer patients, physicians, and clinical research associates (CRAs). A series of questionnaires was developed with items based on these factors and were administered concurrently to 189 cancer patients, their physicians, and CRAs following the patient's decision regarding trial entry. Forward logistic regression modeling was performed using the items significantly correlated (by univariate analysis) with the decision to enter a clinical trial.
A number of items were significantly correlated with the patient's decision. In the multivariate logistic regression model, the patient's perception of personal benefit was the most important, with an odds ratio (OR) of 3.08 (P < .05). CRA-related items involving supportive aspects of the decision-making process were also important. These included whether the CRA helped with the decision (OR = 1.71; P < .05), and whether the decision was hard for the patient to make (OR = 0.52; P < .05).
Strategies that better address the potential benefits of trial entry may result in improved accrual. Interventions or aids that focus on the supportive aspects of the decision-making process while respecting the need for information and patient autonomy may also lead to meaningful improvements in accrual.
This paper reports on the reasons why patients agreed to or declined entry into randomized trials of cancer following discussions conducted by clinicians in both District General and University Hospitals. Two hundred and four patients completed a 16-item questionnaire following the consultation, of these 112 (55%) were women with breast cancer. Overall results showed that 147 (72.1%) patients accepted entry to a randomized clinical trial (RCT). The main reasons nominated for participating in a trial were that 'others will benefit' (23.1%) and 'trust in the doctor' (21.1%). One of the main reasons for declining trial entry was that patients were 'worried about randomization' (19.6%). There was a significantly higher acceptance rate for trials providing active treatment in every arm 98 (80.6%) compared with those trials with a no treatment arm 46 (60.5%), chi2 test P= 0.003. The study outlines a number of factors that appear to influence a patient's decision to accept or decline entry into an RCT of cancer therapy. An important factor is whether or not the trial offers active treatment in all arms of the study. Communication that promotes trust and confidence in the doctor is also a powerful motivating influence.
PURPOSE: This article describes the planning, implementation, and evaluation of a 2-day conference designed to examine the factors related to the participation of African Americans in cancer clinical trials.METHODS: Pre-conference formative evaluations (e.g., focus group discussions and key informant interviews with community leaders and health providers) were conducted in several rural and urban counties in the state of Alabama to determine African Americans' perceptions of participation in clinical research. The findings from these evaluations were used to develop a conference format and agenda. The 2-day conference included: (i) a pretest of African Americans' perceptions of cancer research, participation factors, and communication and recruitment issues; (ii) individual presentations highlighting community leaders, church leaders, and researchers' perspectives regarding minority participation in research; (iii) working group discussions regarding the barriers and solutions to minority participation in research; and (iv) a posttest evaluation to measure changes in African Americans' perceptions of research.RESULTS: Several recruitment barriers and solutions were identified and reported by the working groups. Comparisons of the pretest and posttest measures showed significant (p > .05) and favorable shifts in the areas of perceptions of cancer research, participation factors, communication issues, and recruitment issues. Participation in the conference reflected a positive change in attitudes on these measures. However, the theme, “barriers that contributed to nonparticipation,” did not show any significant changes during the two testing periods. The most critical lesson that resulted from this conference was the need for researchers and community members to have open dialogue about participation in research.CONCLUSIONS: This conference demonstrated that progress can be made when all parties are at the “table” and can be heard. In this model, community members proved to be valuable resources in providing researchers with information that was vital to the success of recruitment and retention studies and trials.
Purpose:
The goal of this study was to examine the effect of a rural community clinical oncology program-based cancer-care intervention program that was launched to increase the number of rural patients with cancer enrolled in clinical trials.
Description of study:
Five rural counties in eastern North Carolina served as intervention communities, and five rural counties in South Carolina served as the comparison region. The intervention counties used a rapid tumor-reporting system, a nurse facilitator who identified and prompted oncologists to enter patients into clinical trials, a quarterly newsletter to primary-care physicians about cancer treatment and clinical trials, and a health educator who focused on community-wide education regarding cancer prevention, treatment, and clinical trial information. Outcomes included changes in knowledge and attitudes about clinical trials among the primary-care providers who were surveyed and enrollment in clinical treatment trials for breast and colorectal cancer, as analyzed by comparing practice pattern data from before and after the intervention.
Results:
The results indicate that the intervention was not effective. The proportion of primary-care physicians who were aware of clinical trials for their patients with cancer rose slightly in comparison counties (26% to 34%) but remained constant (41% to 43%) in intervention counties. Perceived patient and actual physician barriers toward clinical trial participation were reported by the physicians. A minority of potentially eligible patients with breast or colon cancer in both North Carolina and South Carolina were enrolled in clinical trials.
Clinical implications:
These data suggest that different types of interventions may be needed to improve accrual to cancer treatment trials in rural communities. In addition, the role that primary-care providers play in encouraging patients with cancer to participate in clinical treatment trials needs further exploration.
The participation of African Americans in clinical and public health research is essential. However, for a multitude of reasons, participation is low in many research studies. This article reviews the literature that substantiates barriers to participation and the legacy of past abuses of human subjects through research. The article then reports the results of seven focus groups with 60 African Americans in Los Angeles, Chicago, Washington, DC, and Atlanta during the winter of 1997. In order to improve recruitment and retention in research, the focus group study examined knowledge of and attitudes toward medical research, knowledge of the Tuskegee Syphilis Study, and reactions to the Home Box Office production, Miss Evers’ Boys, a fictionalized version of the Tuskegee Study, that premiered in February, 1997. The study found that accurate knowledge about research was limited; lack of understanding and trust of informed consent procedures was problematic; and distrust of researchers posed a substantial barrier to recruitment. Additionally, the study found that, in general, participants believed that research was important, but they clearly distinguished between types of research they would be willing to consider participating in and their motivations for doing so.
To assess attitudes of patients about participation in clinical trials.
This is a self-report survey of 400 patients who underwent general medical evaluations between September and November 2006 at a tertiary care academic medical center in Rochester, MN. We measured knowledge of access to clinical trials, attitudes toward participation, recruitment preferences, and beliefs about research integrity.
Of 485 consecutive patients, 400 (82%) completed the survey. Previous participation in clinical trials was reported by 112 patients (28%). Most were unaware of online information about clinical trials (330 [82%]), were satisfied with their current knowledge (233 [58%]), expected their treating physician to inform them about current trials (304 [76%]), and showed equal interest in participating in conventional or complementary intervention trials (174 [44%]). Of the 400 respondents, 321 (80%) found it appropriate to be contacted by mail and 253 (63%) by telephone regarding study participation. Most patients (364 [91%]) wanted to be informed about research findings or else would not participate in future clinical trials (272 [68%]). The most frequently expected compensation was free parking (234 [58%]). Most thought that their safety (373 [93%]) and privacy (376 [94%]) would be guarded.
Patients are interested in participating in clinical trials but commonly lack adequate information. If patients received more information (through their treating physicians), enrollment might improve. This single-site study has limited generalizability. Future studies involving a diverse group of patients from a broader geographic distribution will help provide more definitive results.
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.
Minority accrual onto clinical trials is of significant interest to cooperative oncology study groups. The Eastern Cooperative Oncology Group (ECOG) conducted a study to identify barriers and solutions to African American accrual onto clinical trials.
We hypothesize that the National Medical Association (NMA) might provide insight into ways to increase minority participation and that ECOG might facilitate that participation. Four sites were selected in which NMA chapters existed and ECOG main institutions with less than half of the corresponding percentage of minorities in their communities entered trials for 1992. Fifteen workshops were conducted using discussions and open-ended, self-administered questionnaires.
Seventy percent of NMA physicians cited mistrust of the research centers, fear of losing patients, and a lack of respect from ECOG institutions as the most important barriers to minority cancer patient referrals, compared with 30% for ECOG physicians. Sixty-nine percent of NMA and 43% of ECOG physicians cited a lack of information about specific trials. Nearly half of NMA physicians (47%) cited a lack of minority investigators as a barrier, compared with 4% of ECOG physicians. Solutions by both groups were improved communication (73%) and culturally relevant educational materials (40%). ECOG physicians cited more minority outreach staff as a potential solution (22% v 6%). NMA physicians cited increased involvement of referring physicians (44% v4%).
NMA physicians who serve a significant sector of the African American population demonstrated a willingness to participate and work with a cooperative group effort to increase participation of minority patients and investigators.
Clinical trials are the principal means by which new treatment approaches are evaluated in medicine. It has been argued that randomised clinical trials provide the highest standard of care and at the same time help to contribute to scientific knowledge. However, only a relatively small proportion of cancer patients receive treatment as part of a formal clinical trial. This article provides a broad review of the issues pertinent to physician and patient participation in randomised clinical trials.
Search of computerised electronic databases (Medline, Psychlit, Cinhail, Embase).
There are a variety of physician and patient characteristics which have previously been shown to influence participation in randomised clinical trials. Additionally, ethical concerns about randomised trials in general and the additional requirements of informed consent for clinical trials, may impact on recruitment. Whilst there is some research examining strategies to improve patient understanding about clinical trials and promote patient involvement in clinical decision-making, there are deficiencies in these areas. In particular there is a paucity of research examining the association between knowledge about clinical trials, anxiety associated with a new cancer diagnosis and willingness to participate in randomised clinical trials.
Further research also is needed to evaluate strategies to better inform patients about clinical trials.
The African American Hereditary Prostate Cancer (AAHPC) Study is an ongoing multicenter genetic linkage study organized by Howard University and the National Human Genome Research Institute (NHGRI), with support from the Office for Research on Minority Health and the National Cancer Institute. The goals of the study are to: (i) look for evidence of involvement of chromosome 1q24-25 (HPC1) in African American men with hereditary prostate cancer (HPC) and (ii) conduct a genome-wide search for other loci associated with HPC in African American men. To accomplish these goals, a network has been established including Howard University, the NHGRI, and six Collaborative Recruitment Centers (CRCs). The CRCs are responsible for the identification and enrollment of 100 African American families. To date, 43 families have been enrolled. Recruitment strategies have included mass media campaigns, physician referrals, community health-fairs/prostate cancer screenings, support groups, tumor registries, as well as visits to churches, barber shops, and universities. By far, the most productive recruitment mechanisms have been physician referrals and tumor registries, yielding a total of 35 (81%) families. Approximately 41% (n = 3400) of probands initially contacted by phone or mail expressed interest in participating; the families of 2% of these met the eligibility criteria, and 75% of those families have been enrolled in the study, indicating a 0.5% recruitment yield (ratio of participants to contacts). As the first large-scale genetic linkage study of African Americans, on a common disease, the challenges and successes of the recruitment process for the AAHPC Study should serve to inform future efforts to involve this population in similar studies.