Participation Of Minorities In Clinical Research Research Articles

Mexican Americans agree to participate in longitudinal clinical research more than non-Hispanic whites

BackgroundThe National Institutes of Health has advocated for improved minority participation in clinical research, including clinical trials and observational epidemiologic studies since 1993. An understanding of Mexican Americans (MAs) participation in clinical research is important for tailoring recruitment strategies and enrollment techniques for MAs. However, contemporary data on MA participation in observational clinical stroke studies are rare. We examined differences between Mexican Americans (MAs) and non-Hispanic whites (NHWs) participation in a population-based stroke study.MethodsWe included 3,594 first ever stroke patients (57.7% MAs, 48.7% women, median [IQR] age 68 [58–79]) from the Brain Attack Surveillance in Corpus Christi Project, 2009–2020 in Texas, USA, who were approached and invited to participate in a structured baseline interview. We defined participation as completing a baseline interview by patient or proxy. We used log-binomial models adjusting for prespecified potential confounders to estimate prevalence ratios (PR) of participation comparing MAs with NHWs. We tested interactions of ethnicity with age or sex to examine potential effect modification in the ethnic differences in participation. We also included an interaction between year and ethnicity to examine ethnic-specific temporal trends in participation.ResultsBaseline participation was 77.0% in MAs and 64.2% in NHWs (Prevalence Ratio [PR] 1.20; 95% CI, 1.14–1.25). The ethnic difference remained after multivariable adjustment (1.17; 1.12–1.23), with no evidence of significant effect modification by age or sex (Pinteraction by age = 0.68, Pinteraction by sex = 0.83). Participation increased over time for both ethnic groups (Ptrend < 0.0001), but the differences in participation between MAs and NHWs remained significantly different throughout the 11-year time period.ConclusionMAs were persistently more likely to participate in a population-based stroke study in a predominantly MA community despite limited outreach efforts towards MAs during study enrollment. This finding holds hope for future research studies to be inclusive of the MA population.

Participation in phase I oncology trials by minorities: Survival and compliance data.

e18628 Background: Since 1993, the National Institutes of Health requires all clinical trials to include women and minority participation in clinical research. Despite this initiative, Minority (M) participation in Phase I Oncology clinical trials is subpar; historical data indicate a participation of 79% Caucasian (C) versus 21% (M) in Phase I clinical trials. The purpose of this study is to compare demographics, survival, and compliance data between (C) versus (M) patients participating in Phase I Oncology clinical trials in our Cancer Institute. Methods: We performed a retrospective analysis in all patients enrolled in phase I clinical trials in our institution from April 2019 until October 2022. This information was obtained via OnCore. Data was abstracted manually and entered in a spreadsheet (Excel). Data variables include race, gender, withdrawal of consent, and lost follow-up. Statistical plan was determined by our statistical team with data analysis to be performed with statistical software to generate Kaplan Meyer (KM) Survival Curve. Results: A total of 99 patients were identified. 61.5% were (C) and 38.4 % were (M). (M) consisted of Hispanic (81%), African American (18%) and Asian (1%). Female Gender on (C) were 57.4% and 55.3% on (M). Lost follow-up was 2.8% on (C) and 5.9% on (M). Withdrawal of consent was 5.6% on (C) and 0% on M. The (KM) curve revealed non statistically significant difference in survival p = 0.7316. Conclusions: In our analysis, we found statistically similar (KM) survival curves for (C) and (M) participating in Phase I clinical trials (p = 0.7316). We found a significant higher participation of (M) patients in our institute than historical data. There was no significant difference in withdrawal of consent between (C) and (M) and no difference on lost follow-up. We plan to identify patterns of success in enrolling minorities in our site and validate a questionnaire to screen patients for Phase I clinical trials with the goal to minimize perception bias and barriers for enrollment of (M) in Phase I studies.

232 Trauma-informed, culturally responsive clinical and translational research with African American communities

OBJECTIVES/GOALS: To present a community engaged pilot study of minority participation in clinical research that translates principles of trauma informed care and culturally responsive education into research practices for Investigators that elevate African American patients’ trauma survivorship, and prioritize their values for meaningful research engagement. METHODS/STUDY POPULATION: Data will generated from Phase 1 pilot project research activities including: a) a scoping review of trauma-informed care and culturally responsive education principles, and published recommendations for translating these principles to clinical research practices, b) semi-structured Key Informant interviews (~10) capturing the perceived impact of trauma on Portland-area African Americans’ health, well-being, and clinical research participation, and c) a 2-day stakeholder council meeting with clinicians, patients, community health workers, Investigators, and IRB staff that will prioritize the clinical research principles and practices that matter most to African American patients, from pre-design to dissemination. Data will be collected Fall 2022/Winter 2023, and analyzed in Winter 2023. RESULTS/ANTICIPATED RESULTS: The results will empirically validate published recommendations on how to apply trauma-informed, culturally responsive (TICR) principles to clinical research practices, specifically for African American patients. They will illuminate the sociocultural and historical contexts under which clinical research is conducted with minoritized patients--drawing on the experiences of personnel who intersect at various levels of the clinical research ecosystem, and African American patients with varying experiences with clinical research. Results will illuminate challenges, needs, assets, cultural funds of knowledge, and values for meaningful research engagement, and provide practical, tangible strategies for Investigators to align with equity- and justice-based clinical research practices. DISCUSSION/SIGNIFICANCE: The TICR research approach disrupts the cycle of trauma, health disparities, and low minority research participation through a paradigm shift that equips Investigators to exercise universal precautions to minimize harm, protect African American research participants from retraumatization, prioritize their cultural values, and promote safety.

Development of a web tool to increase research literacy in underserved populations through public library partnerships.

ObjectiveInadequate diversity in clinical trials is widely recognized as a significant contributing factor to health disparities experienced by racial/ethnic minorities and other diverse populations in the US. To address this in a scalable way, we sought to develop a web tool that could help enhance underserved minority participation in clinical research.MethodsWe used our research literacy support flashcard tool as the initial prototype for human-centered design and usability testing of the web tool Health for All in public library settings. After forming partnerships with leadership from Chicago Public Libraries (CPL), local medical libraries, and the Chicago Department of Public Health, we conducted seven iterative design sessions with focus groups of library patrons and library staff from six CPL branches serving underserved communities followed by two rounds of usability testing and website modification.ResultsBased on the qualitative research findings from Design Sessions 1–7, we enacted the design decision of a website that was a hybrid of fact-filled and vignette (personal stories) paper prototypes divided into 4 modules (trust, diversity, healthy volunteers, pros/cons), each with their own outcome metrics. The website was thus constructed, and navigation issues identified in two rounds of usability testing by library patrons were addressed through further website modification, followed by the launch of a beta version of a hybridized single-scrolling and guided module prototype to allow further development with website analytics.ConclusionsWe report the development of Health for All, a website designed to enhance racial/ethnic minority participation in clinical trials by imparting research literacy, mitigating distrust engendered by longstanding racism and discrimination, and providing connections to clinical trials recruiting participants.

From Intention to Action: Operationalizing AGA Diversity Policy to Combat Racism and Health Disparities in Gastroenterology

From Intention to Action: Operationalizing AGA Diversity Policy to Combat Racism and Health Disparities in Gastroenterology

Learning and Action in Community Health: Using the Health Belief Model to Assess and Educate African American Community Residents about Participation in Clinical Research

The Learning and Action in Community Health project was implemented to gather preliminary data needed to inform community-engaged educational approaches to increase clinical research participation among racial minorities. The Health Belief Model was the theoretical framework utilized to develop the intervention and assessment tools. An educational session about clinical research and biorepository participation was designed using clinicaltrials.gov information and administered to adult, African American community residents (n = 60) in Atlanta, Georgia. Pre- and post-tests were collected and analyzed to assess changes in participants’ knowledge, perceptions, and willingness to participate in clinical studies and biorepositories. There were statistically significant changes in knowledge about joining a clinical study (p < 0.001) and registry or biorepository (p < 0.001). There was no statistically significant change in willingness to participate in clinical research or biorepositories after the educational session. Focus groups were conducted to gather feedback on the educational session and perceived barriers and benefits to participating in clinical research. Perceived benefits were improving health, receiving incentives, early detection of health issues, and access to care. Perceived barriers included fear, lack of knowledge, historical mistrust of research, and time constraints. Results have implications for subsequent community-engaged approaches to increasing minority participation in clinical research.

Improving Research Literacy in Diverse Minority Populations with a Novel Communication Tool.

Racial/ethnic minorities are underrepresented in clinical research in the USA for multifarious reasons, including barriers to effective communication between researchers and potential research participants. To address the communication barriers between researchers and potential participants, we developed a Research Literacy Support (RLS) tool. The focus of this report is to present findings from the second and third phases of development that refined and assessed usability of the RLS tool. We utilized a mixed-methods approach that entailed iterative cognitive testing with participants (N = 52) from diverse racial/ethnic backgrounds and interviews with clinical research recruiters (N = 20) to modify and refine the design and content of the RLS tool (phase 2). This was followed by assessment of the usability of the RLS tool by 100 participants (phase 3). During phase 2, participants provided feedback about layout, word choice, and comprehension of the tool. In phase 3, participants recognized that they had gained knowledge about clinical research from the RLS tool, although they still had a substantial learning gap after using the tool, indicating an opportunity for further refinement. The RLS tool may help advance health equity by addressing communication barriers that may impede minority participation in clinical research.

Abstract A25: Community research navigators: The bridge to increasing ethnic minority participation in clinical research

Abstract The participation of underserved ethnic minorities in clinical research is critical to achieving progress in cancer control. Ethnic minority patient accrual in clinical trials is a formidable challenge that requires patient trust, commitment, and overcoming of barriers. Racial and ethnic minorities make up about 40% of the United States population, yet are not well represented in research studies. Less than 10% of all patients with cancer enrolled in clinical trials are minorities. Diverse participation may lead to more generalizable results for under-represented groups, more best practices for prevention and treatment to specific minority groups, increase in knowledge and awareness of disparities about cancer, and a more accurate reflection of the United States' increasingly diverse population. Although there is a proliferation of patient navigation programs to increase health care among the underserved, there is little known on its potential effects as a strategy to enhance minority clinical trial and biospecimen accrual. City of Hope has built a functional and sustainable program for addressing health inequity, which includes training a network of community research navigators (CRN) to address gaps in knowledge, medical mistrust, and access, and navigate participation and engagement of under-represented groups in research. The research navigator program draws from the patient navigation and promotora model and is a novel and innovative application to this approach. This approach has utility and applicability to address research participation barriers, including trust and referrals. It promises sustainability and cost effectiveness as trained CRNs can deliver the program. The Community Research Navigator (CRN) project enhances community advocates' capacity by training community health leaders/promotoras as community research navigators (CRN) to widen the dissemination of the clinical trial and research participation enrollment for increased ethnic minority participation in clinical trials and health-related research. CRNs attended a 1-day training on clinical trials and research. The training included educating and encouraging individuals to proactively think about and discuss clinical trial participation with their family, friends, and health care providers; disseminating information about specific research studies, targeting the African and Latino communities; and referring individuals to specific biospecimen, clinical trials, and population studies. In total, we trained and mentored a team of 14 CRNs. Participants were 24-66 years old; most were female (86%), Latino (69%), and single (43%). After participating in the training, participants were more likely to correctly define HIPAA (p=.040) and the types of clinical trials (p=.038). In addition, CRNs were more likely to encourage clinical research participation among their family after the training (p=0.034). Further, we measured confidence in various domains, including: increase in confidence in describing the purpose and process of clinical research (p=0.006); educating minority communities about clinical trials (p=0.045); and providing informational workshops/forums on clinical research (p=0.046). Participants had an increase in overall confidence (p=.033). Our findings demonstrate that the CRN strategy holds promise in increasing minority participation in cancer clinical trials. It is an innovative application of the extensively studied patient navigation approach that warrants research. Future research should focus on the CRN project as a cost-effective tool for enrollment and retention of ethnic minorities in cancer clinical trials and the potential of enhancing clinical trial understanding outcomes among participants. Citation Format: Marisela Garcia, Mayra Serrano, Alejandro Fernandez, Katty Nerio, Kimlin Ashing. Community research navigators: The bridge to increasing ethnic minority participation in clinical research [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr A25.

Exploring Willingness of Elder Chinese in Houston to Participate in Clinical Research.

Background and objectivesInadequate minority participation in clinical research can threaten the applicability and strength of scientific findings. Previous research suggests that trial participation rates are lowest among Asian Americans, compared to other groups. This study explored barriers to clinical research participation among elder Chinese living in Houston, Texas. Additionally we administered the Trust in Medical Researchers Scale (TIMRS), used previously in researching trust in medical researchers as related to research participation.DesignIn this mixed methods study, a semi-structured interview, including the TIMRS were administered to 30 adults of Chinese ancestry aged 50 years or older recruited from a Chinese community center. Interviews were conducted in English, Mandarin and Cantonese and independently coded and analyzed using thematic content analysis. TIMRS scores were calculated for participants.ResultsParticipants were 70% female, 70% were 60 or elder, all were foreign born and on average lived in the US for 21.8 years. Participants perceived risks to research participation and preferred language concordant research staff. Interviewees were more willing to participate if they perceived personal and community health-related benefits. The overall TIMRS score was 23.9 (±5.0), lower than the overall TIMRS for Whites in a previous study (P < 0.001).ConclusionsThe barriers and facilitators to research participation confirmed previous research among Asians. Our participant TIMRS scores were consistent with decreased levels of trust observed in the original TIMRS study for African Americans as compared and lower than Whites. Employing strategies that utilize language concordant staff who build trust with participants may aid in recruiting elder Chinese, especially if the research is personally relevant to those being recruited.

Abstract B02: Promotores advancing knowledge and participation in cancer research studies.

Abstract Background and Purpose: Less than three percent of all adult cancer patients participate in cancer research studies. Participation is even lower for patients from underserved Latino populations. Community Health Workers (Promotores de Salud) have been shown to improve minority participation in clinical research and access to care. The objective is to describe the development and implementation of a theory-based, language and literacy appropriate training program to advance awareness and interest in cancer research studies among Latinos. Our central hypothesis is that a culturally sensitive, language and literacy appropriate program will improve a) knowledge about cancer research studies and b) attitudes regarding participation. Study Design: The study was carried out in three phases: 1) Building an infrastructure for a commu nity based participatory research program; 2) Training promotores utilizing a community-based curriculum; and 3) Using Paulo Freire's education model, we designed and implemented a cancer 101 and a cancer research studies training program. Prior to the training, Latino community members completed a pre-assessment that included demographic, socio-economic information, and open ended questions about cancer topics and cancer research studies. Results: A total of 27 Promotores enrolled in the training program and 22 (81.48%) completed the three sessions. At the end of the training session, 92% believed that it was very important for community members to learn about cancer research studies and 85% felt comfortable talking about cancer research studies in their communities. Impact: Our study demonstrated the feasibility of recruiting and engaging promotores to improve community knowledge of cancer research studies and attitudes regarding participation in cancer research studies. This initial step will inform the development of future community-based interventions. Citation Format: Ana Paula Cupertino, Johana Bravo De los Rios, Mercedes Saint-Elin. Promotores advancing knowledge and participation in cancer research studies. [abstract]. In: Proceedings of the Fifth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2012 Oct 27-30; San Diego, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2012;21(10 Suppl):Abstract nr B02.

Ethnic minority participation in Community Clinical Oncology Program (CCOP) research studies

1550 Background: Low minority participation in clinical research is concerning for both research and for the public health. Objective: The aim of this project was to investigate barriers and successes in minority participation in cancer medical research and cancer clinical trials. More specifically to: (1) determine major environmental, cultural, and economic barriers confronted by minority patients with cancer; and (2) determine the components of an environment that supports greater recruitment and retention of minorities to Clinical Community Oncology Practice (CCOP) cancer studies. Methods: Six focus groups consisting of 8 to 12 current or former minority cancer patients and 18 health care practitioners, from geographically diverse areas, were recruited to participate in this qualitative study. Focus group participants were asked questions about their attitudes and beliefs concerning their cancer and medical research. Health care practitioners were questioned on site recruitment and retention practices. Results: Two major thematic areas emerged for providers: barriers minority recommendation to trials and reasons for why minorities are underrepresented in trials. The three thematic areas for focus group participants were perceptions of medical research, reasons for participation or nonparticipation, and effects of Tuskegee Syphilis Study on participation. Conclusions: The Tuskegee Syphilis Study may have been a major impetus for why many Blacks and other minorities in this sample do not participate in medical research. Providers seem to state what was obviously important in connecting with the community, however, their actions in the community varied. This qualitative study gives voice to communities which mistrust the medical community in general and medical research in particular, and highlights the need for interventions bridging the community and research. No significant financial relationships to disclose.

Comparison of Electronic Physician Prompts versus Waitroom Case-Finding on Clinical Trial Enrollment

BackgroundRecruiting patients into clinical research protocols is challenging. Electronic medical record (EMR) systems capable of prompting clinicians may facilitate enrollment.ObjectiveTo compare an EMR-based clinician prompt versus a wait-room-based case-finding strategy at enrolling patients into a clinical trial.DesignCross-sectional comparison of recruitment data from two trials to treat anxiety disorders in primary care. Both studies utilized similar enrollment criteria, intervention strategies, and the same four practice sites and EMR system.ParticipantsPatients referred by their (primary care physicians) PCPs in response to an EMR prompt (recruited 1/2005–10/2006), and patients enrolled by research assistants stationed in practice waiting rooms (7/2000–4/2002).MeasurementsReferral counts, patients’ baseline sociodemographic and clinical characteristics.ResultsOver a 22-month period, EMR-prompted PCPs referred 794 patients and 176 (22%) met study inclusion criteria and enrolled, compared to 8,095 patients approached by wait room-based recruiters of whom 193 (2.4%) enrolled. Subjects enrolled by EMR-prompted PCPs were more likely to be non-white (23% vs 5%; P < 0.001), male (28% vs 18%; P = 0.03), and have higher anxiety levels than those recruited by wait-room recruiters (P < 0.0001).ConclusionsEMR systems prompting clinicians to refer patients with specific characteristics are an efficient recruitment tool with critical implications for increasing minority participation in clinical research.

Commentary on “Increasing Minority Participation in Clinical Research”: A White Paper from The Endocrine Society

Underrepresentation of racial and ethnic minorities in clinical research limits the applicability of trial results to diverse subpopulations. Recognizing an ongoing need to increase participation by minorities, The Endocrine Society established a task force of thought leaders from all stakeholder groups—the pharmaceutical industry, federal agencies, academia, and community groups—to develop a white paper outlining recommendations for meeting this need. The primary goal is to ensure that clinical research supporting the safety and efficacy of pharmaceutical products and the validity of biomarkers used to design therapeutic strategies is based on statistically powered data derived from minority subpopulations. To realize…

APA `Tour' Spreads Word On MH Disparities

APA `Tour' Spreads Word On MH Disparities