Minority Participation In Clinical Trials Research Articles

Addressing the Ethnicity Gap in Catechol O-Methyl Transferase Inhibitor Trials in Parkinson's Disease: A Review of Available Global Data.

Catechol-O-methyltransferase inhibitors (COMT-Is) have significantly improved the quality of life and symptom management for those at advanced stages of Parkinson's Disease (PD). Given that PD is one of the fastest-growing neurodegenerative diseases worldwide, there is a need to establish a clear framework for the systematic distribution of COMT-Is, considering inter-individual and intra-individual variations in patient response. One major barrier to this is the underrepresentation of ethnic minority participants in clinical trials investigating COMT-Is. To investigate this, we performed a narrative review. We searched PubMed for clinical trials investigating COMT-Is in patients with PD and examined the ethnic diversity of cohorts. A total of 63 articles were identified, with 34 trials found to match our inclusion criteria. Among the 34 trials meeting our inclusion criteria, only 8 reported participants' ethnic backgrounds. Our findings reveal a consistent underrepresentation of ethnic minority groups in trials investigating COMT-Is in PD cohorts-a trend that reflects broader concerns across clinical research. In this review, we explore potential reasons for the underrepresentation of ethnic minorities in clinical trials and propose strategies to address this issue.

Overcoming racial and ethnic disparities in clinical trial enrollment real world evidence from an NCI-Designated Cancer Center in a minority majority county.

e13708 Background: Significant racial and ethnic disparities continue to persist in clinical trial enrollment. Specifically, Asian and Hispanic individuals are severely underrepresented compared to their census estimates and make up as little as 1% and 6% respectively of all clinical trial enrollments [PMID: 35875251]. This limits the generalizability of clinical trials and consequently the application of novel therapeutics for diverse populations. This observational study looks at enrollment demographics at the University of California, Irvine (UCI) with an emphasis on minority participation in clinical trials. We hypothesized that minorities would be underrepresented in our enrollment population. Methods: The UCI Chao Family Comprehensive Cancer Center (CFCCC) is located in Orange County (OC), CA, a minority-majority county. Enrollment data from clinical trials was collected from 2015-2023 through the CFCCC clinical research database. Demographics were compared to data provided by the NIH SEER reports in both OC and United States. Results: Between 2015-2023, 2315 individuals across 3 UCI Health facilities were enrolled. Demographics were as follows: White, Asian, Black, American Indian/Alaska Native, mixed/unknown race (66.4%/20.1%/2.4%/0.7%/0.7%/ 9.3%). Non-Hispanic vs Hispanic ethnicity (77.8%/20.6%). Female vs Male sex (47.6%/52.3%). Age <70 vs >70 years (78.6%/21.4%). Low Income/Health Professional Shortage Areas (HPSA) vs non-Low Income/HPSA (44.9%/55.0%). Study Phase: Phase I/II (39.2%), Phase II (28.0%), Phase III (29.3%), Phase II/III (3.0%), and Phase IV (0.3%). Study sponsor: Industry (61.2%), Investigator initiated (23.5), Cooperative group (14.9%), other (0.3%). Most notably, the Asian enrollment (20.1%) and Hispanic enrollment (20.6%) exceeded demographic representation of Asians (15.6%) and Hispanics (17.3%) in OC. Conclusions: Our results demonstrate that accrual of minorities is feasible across all types of clinical trials. These findings suggest that minorities are not inherently less likely to enroll in clinical trials. A clinical trial portfolio mirroring the catchment area might improve accrual of minorities. Enrollment based on race/ethnicity and trial phase/sponsor will be presented at the meeting.

Ethnic Minority Participation in Clinical Trials from Latin America and the Caribbean: A Scoping Review.

We summarize the clinical trials (CTs) main characteristics, including members of ethnic minorities from Latin America. We carried out a systematic search in six databases. We made a descriptive synthesis of CTs, summarizing the characteristics, interventions, main findings, results, and conclusions reported. 4411 studies were acquired in search strategy, leaving 24 CTs in the final selection. Of these, ten were randomized, four were non-randomized, and the remainder had other designs. Most of the studies were carried out in the population of infants and children (08), ten of the studies included only women, and two studies included men. Nine studies were conducted in Mexico, with the Mayan ethnic minority being mostly evaluated (05). In only 15 it was mentioned that their research was approved by a research ethics committee. Finally, half of the CTs reported funding from international agencies and third reported funding from government agencies. Our results show that that CTs in ethnic minorities are limited and reduced to a few native peoples of the continent.

Abstract IA028: Achieving health equity: Inclusive participation in clinical trials

Abstract Minority participation in clinical trials is imperative to develop new prevention, detection, and treatment modalities for cancer because study samples must be representative to generalize findings to the disease population. As of 2020, low-SES populations, which have minority race/ethnicity prevalence, saw significantly greater risk from cancer mortality than their White, higher-income counterparts. This population has higher mortality from breast cancer (+10%), prostate cancer (+16%), colorectal cancer (+17%), and liver cancer (+26).1-2 Myriad drivers of health inequities3 act as barriers to clinical trial participation.1 Patient barriers include sociocultural and physical environment factors, while physician’ barriers include perceived loss of control, uncertainty, and lack of time to discuss research options.1 For example, 87% of patients surveyed in 2020 reported never having been invited to participate in a clinical trial with 41% not knowing anything about clinical trials; 9% had been asked, with <5% participating. Disparities were evident by minority race, low education level and income, and rurality.1,4 Retention and compliance barriers included participants’ loss of interest in the study, not having been assigned to a desired treatment, older age, low education, unemployment, and logistical barriers, such as transportation and child-care.4-5 Incorporating patient navigation programs into clinical trials helps correct for misinformation and builds trust between researchers and community members.5-7 The Increasing Minority Participation in Clinical Trials (IMPaCT) study (2007-2014, N=272), trained lay patient navigators (PNs) to guide patients through the eligibility process to enroll in cancer clinical trials at UAB. PNs also provided tailored support, including assistance with transportation and lodging, appointment reminder calls, social service referrals as appropriate, and linking patients with peer support. African American participation in therapeutic cancer clinical trials increased from 9% to 16%.4,6 UAB has had similar success with other patient navigation and health coaching studies, confirming PN benefits.8-10 An often overlooked barrier is researcher or physician implicit bias and the role bias plays in study design, particularly with regard to participant recruitment.11 Although everyone has biases, acknowledging how those biases affect our judgement and behaviors can be uncomfortable to process.12 When we address bias directly and take purposeful actions to mitigate implicit bias, patients benefit, enrollment increases among the populations most at risk, and results become generalizable.13-14 With the increasing amount of readily-available population-level data on incidence and mortality from various types of cancer registries, likely barriers to participation, including both patient-and researcher-centered, can be identified early in a study’s development and addressed during plan development. Finally, incorporating patient navigation into recruitment plans will enhance enrollment in cancer clinical trials. Citation Format: Mona N. Fouad. Achieving health equity: Inclusive participation in clinical trials [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr IA028.

Racial and ethnic minority participants in clinical trials of acute respiratory distress syndrome

PurposeThere is growing interest in improving the inclusiveness of racial and ethnic minority participants in trials of acute respiratory distress syndrome (ARDS). With our study we aimed to examine temporal trends of representation and mortality of racial and ethnic minority participants in randomized controlled trials of ARDS.MethodsWe performed a secondary analysis of eight ARDS Network and PETAL Network therapeutic clinical trials, published between 2000 and 2019. We classified race/ethnicity into “White”, “Black”, “Hispanic”, or “Other” (including Asian, American Indian or Alaskan Native, Native Hawaiian, or other Pacific Islander participants).ResultsOf 5375 participants with ARDS, 1634 (30.4%) were Black, Hispanic, or Other race participants. Representation of racial and ethnic minority participants in trials did not change significantly over time (p = 0.257). However, among participants with moderate to severe ARDS (i.e., partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 150), the difference in mortality between racial and ethnic minority participants and White participants decreased over time. In the five most recent trials, including 2923 participants with ARDS, there were no statistically significant differences in mortality between racial/ethnic groups, even after adjusting for potential confounders. In these five most recent trials, mortality was 31% for White, 31.9% for Black, 30.3% for Hispanic, and 37.1% for Other race participants (p = 0.633).ConclusionRepresentation of racial and ethnic minority participants in ARDS trials from North America, published between 2000 and 2019, did not change over time. Black and Hispanic participants with ARDS may have similar mortality as White participants within trials.

Abstract B076: A qualitative exploration of women’s understanding of clinical research and decisions to participate: Improving diversity in clinical research

Abstract BACKGROUND: Twenty-nine years since the National Institutes of Health (NIH) Revitalization Act was passed to encourage minority participation in clinical trials (CTs), and yet there remains a deficit of minorities recruited into CT. This induces the idea that Women-of-Color (WoC) (Blacks, Latinas, Native Americans, Asians) are less likely to participate than their Northern/European White (NE/W) counterparts. Using a mixed methods study that included quantitative surveys and qualitative interviews, we dive into understanding how a diverse group of women understand and perceive CT, along with concerns and attitudes towards clinical research. METHOD: The interview script was designed to capture patients’ understanding and concerns of clinical research, reasons for agreeing or declining participation, and facilitators or barriers to participation. The CRAs were trained in establishing rapport with the patient, clearly communicating the questions, and probing for more elaboration of responses. Interviewees and interviewers were matched based on gender and race. A total of four CRAs conducted the interviews – two Asian CRAs interviewed the Asian participants, one Latina CRA interviewed Latinas and White, non-Hispanics, and one African American CRA who interviewed the African American participants. Structured individual interviews were conducted by trained CRAs. The audio-recordings of all interviews were transcribed word for word and reviewed for accuracy. Two independent coders then read and coded each transcript and extracted a set of quotes (phrases or sentences) that reflected the themes. RESULTS: A total of 44 women were accrued between August 2019 and February 2020. The racial/ethnic makeup include the following: 20 Latinas ([White/Hispanic] - one Salvadorian, one half Mexican/half Armenian, and 18 Mexican), 8 Asian (one half Chinese/half Japanese, one Indian, three Chinese, two Vietnamese, one Thai), 8 African American/non-Hispanic, and 8 White/non-Hispanic (two Iranian and 6 European). Age range of women were 27 to 71 years of age. Seventeen women declined participation. CONCLUSION: The in-person interviews highlighted feelings of cultural mistrust among the WoC participants and not in the NE/W participating in the study. The results highlight the influence of cultural mistrust as a barrier and the importance of diversity of the clinical research team in overcoming this barrier, particularly among WoC clinical trial participants. Of course, there is undeniable heterogeneity within the WoC population; each community is influenced by its own historical and present contexts that influence its relationship with the medical system. Approaches to overcome this barrier must address the specific needs of each community. Diversity of the clinical research team and the ability of the team to address culturally relevant beliefs can increase trial diversity. The generalizability, quality, and effectiveness of healthcare treatment requires diverse representation in all clinical trials. Citation Format: Veronica Jones, Noe Chavez, Vanessa M. Robles, Laura Kruper, Lily Lai, Amy Polverini, Lusine Tumyan, Lesley Taylor, James Waisman, Angelica Sanchez, Christine Thai, Tanya Chavez, Nikita Wright. A qualitative exploration of women’s understanding of clinical research and decisions to participate: Improving diversity in clinical research [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B076.

Enhancing accrual to clinical trials of minority patients with gynecologic malignancy.

e13535 Background: Central to improving survival of patients with gynecologic malignancy is participation in therapeutic, surgical and preventative clinical trials. Minority population accrual is particularly poor representing a disparity in cancer care. We sought to evaluate enrollment of minority populations at an urban NCI-designated Comprehensive Cancer Center before and after the NCI call to action June 2020. Methods: Data on patient enrollment in gynecologic oncology clinical trials (14 therapeutic and 4 non-therapeutic) was obtained from Perlmutter NCI-designated Comprehensive Cancer Center. Primary outcomes were the proportion of newly accrued patients by race participating in trials between January 2019 to September 2021. Results: Over the entire study period 154 total patients were enrolled in therapeutic and non-therapeutic clinical trials. Enrollment by cancer type included 100 (71.4%) ovarian, 16 (7.1%) uterine, 12 (7.9%) cervical and 26 (13.5%) solid tumor trials. White patients comprised 69% (69 of 100) of patients on ovarian cancer trials. Uterine cancer trials by race consisted of 50 % White, 37.5% Black, 6.2% Asian and 6.2% Other race patients. Eighty-eight patients were enrolled into clinical trial prior to the NCI alert. By race these patients were: White, 65.9% (58 of 88); Black, 3.4% (3 of 88); Asian, 11.4% (10 of 88) and Other race, 19.3% (17 of 88). Hispanic patients comprised 13.6% (12 of 88) of the population. Following the call to action an additional 66 patients were enrolled in clinical trial. This included 42 (63.6%) White, 14 (21.2%) Black, 5 (7.57%) Asian, 5 (7.6%) Other race and 8 (12.12%) Hispanic patients. The percentage of Black patients enrolled in clinical trial increased four -fold over the time period (3.4% vs 21.2%, p &lt; 0.05). Conclusions: Overall during this time period we found an increase in number of Black patients accrued to clinical trial. This indicates disparities in clinical trial enrollment can be modified by institutional awareness. The role of patient education, financial and logistical barriers and language discordance to minority participation in clinical trials should be studied further.

Assessing Multiple Factors Affecting Minority Participation in Clinical Trials: Development of the Clinical Trials Participation Barriers Survey.

The purpose of this review is to analyze factors that influence individuals' decisions to participate in clinical trials focusing on racial and ethnic disparities that exist in clinical trials. These factors are then used to develop a survey that may be used in a clinical setting to further understand specific factors affecting participation. A comprehensive search of electronic databases was carried out for publications from 2010 to 2021 using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. After reviewing the data, the predominant factors that were encountered in the search were then commented upon and reviewed to create an evidence-based questionnaire. ​​​​Using the comprehensive search, factors that affect clinical trial participation were identified. These factors were then used to create a comprehensive, evidence-based questionnaire to be implemented in a clinical setting to conduct and analyze the factors impacting participation in clinical trials. ​​​​​​​Understanding the factors that primarily impact an individual's decisions to participate or not participate in a clinical trial allow researchers to implement changes to decrease the hesitancy regarding participation.

Abstract IA-51: If not now, then when? Tackling barriers to clinical trials to ensure inclusion of underrepresented minorities

Abstract The low representation of underrepresented minorities in clinical trials is well known. Unfortunately, there appears to be modest progress in the inclusion of these groups in the nearly 30 years since the NIH Revitalization Act of 1993. Racial and ethnic diversity in clinical trials is imperative for ensuring that novel cancer therapies, behavioral interventions and other types of scientific advances reach and are relevant to all population segments. It will be impossible to eliminate disparities and achieve health equity without diversity and inclusion in clinical research. Many barriers exist to clinical trials and some may be exacerbated among racial/ethnic minorities. This presentation will discuss multilevel barriers to participation in clinical research, share engagement principles related to partnerships with African American/Black and Latino/Latinx populations, and provide lessons learned from institutional and investigator led-initiatives. Data sources include chart reviews, patient interviews and surveys. Selected clinical studies will be discussed along with qualitative and quantitative data. The overall goal is to identify actionable steps towards a collective path of improving minority participation in clinical trials. Strategies that optimize opportunities for system change may have greater impact than strategies that focus solely on patient and/or community attitudes or behaviors. Given the COVID-19 pandemic, public awareness about clinical trials may be at a record high. Thus, community conversations about science and the clarion call for social justice may be the energy needed for cancer scientists to collaborate and change the narrative regarding participation of underrepresented minorities in research. Citation Format: Vanessa B. Sheppard. If not now, then when? Tackling barriers to clinical trials to ensure inclusion of underrepresented minorities [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr IA-51.

Abstract PO-078: Introduction of implicit bias training to oncology faculty as a quality improvement initiative

Abstract Background: In a review, Hall (2015) found that implicit bias was significantly related to patient-provider interactions and health outcomes. Implicit Bias Training is a tool to help individuals understand and take corrective action for unfair behaviors. Purpose: Our goal was to assess physician attitudes towards Implicit Bias Training and to measure physician participation in the training when implemented as an NCCN quality measure. Methodology: Implicit Bias Training was offered by the DEI Office at Yale-New Haven Health. This incentivized quality initiative was required for all practicing oncologists. Of 109 physicians, 45 (41.3%) completed this training. The anonymous survey, which included a link to the Harvard Implicit Project's Implicit Association Test (IAT), was emailed to the 45 oncologists prior to participation in the session. There were 21 respondents (46.7% response rate). Results: The self-reported results of the IAT are as follows: 9.5% (n=2) report a strong automatic preference for European Americans (EA) vs. African Americans (AA). 23.8% (n=5) report a moderate automatic preference for EAs vs. AAs 42.9% (n=9) reported little to no automatic preference between AAs vs. EAs. 4.8% (n=1) report a slight automatic preference for AAs vs. EAs. 19% (n=4) did not participate in the IAT. 33.3% (n=7) of physicians report being either extremely or moderately surprised by the result of their IAT, while 33.3% (n=7) report being neither surprised nor unsurprised. 14.3% (n=3) report being moderately unsurprised, and the remainder did not respond. Physicians were asked to report their enthusiasm about Implicit Bias Training on a scale of 0 to 10. The Mean was 6. While physician enthusiasm reports show polarization not apparent by the mean, 57.1% (n=12) of physicians report being hopeful or very hopeful that training would help to improve both collegial and patient-physician relationships. Conclusion: Though this was a mandatory quality initiative that was incentivized, participation was less than 50%. Explanations for the observed participation rate are multifactorial and nuanced. Of the 17 respondents who completed the IAT, nearly one-half (n=7) reported strong or moderate bias for one racial group, and 41% report being surprised by their result. Our findings suggest that unconscious bias was demonstrated in a significant percentage of participants, many of whom were surprised by their results. The results support the need for Implicit Bias Training as part of ongoing oncology quality improvement. 57% of participating physicians were optimistic that the initiative would lead to positive changes. Future Work: We postulate that bias training could increase awareness and result in improved communication with minority patients. Our next project will evaluate the effect of Implicit Bias Training on minority participation in clinical trials. Inclusivity and representation in clinical trials is paramount in efforts to democratize cancer care and our study suggests that bias training could be a valuable tool to achieve this goal. Citation Format: Renee C. Taylor, Andrea Silber. Introduction of implicit bias training to oncology faculty as a quality improvement initiative [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-078.

Understanding Factors That Determine Clinical Trial Enrollment for African American Patients with Lymphoma

Background: Although the incidence of non-Hodgkin lymphoma (NHL) is lower in minority populations, there is a difference in presentation, survivorship and participation in clinical trials (Becnel et al., 2017). African American patients with diffuse large B-cell lymphoma (DLBCL) present with more aggressive features including higher lactate dehydrogenase, increased frequency of B-symptoms, and higher rate of HIV co-infection, while also presenting at a younger age than other patients. (Tiu et al., 2020). Given the association of race with lymphoma presentation and outcomes, minority participation in clinical trials is of vital importance when developing novel therapies. There have been efforts to increase participation of African Americans in cancer clinical trials including patient navigation outreach which resulted in improvement of 9% to 16% of patients approached (Fouad et al., 2016). However, a recent study illustrated that for DLBCL, acute myeloid leukemia, and acute lymphoblastic leukemia, individuals of African descent represented 1.5%, 2.3%, and 6.7% of clinical trial participants, respectively (Gopishetty et al., 2020). We are conducting the current study to identify factors that influence decisions regarding clinical trial participation in African American patients with NHL.Methods: We are identifying African American patients with diffuse large B cell lymphoma and follicular lymphoma who enrolled in a therapeutic clinical trial at Emory University between 2010-2020. We will utilize the electronic medical record to identify patient characteristics such as distance from medical facility, insurance status, type of insurance, comorbidities, education status, type of diagnosis, and race of diagnosing physician. This data will compare African American patients who participated in clinical trials to those who did not participate as part of their initial treatment, specifically comparing baseline characteristics of interest between the groups. Furthermore, the data mention above will be compared between African American and white patients. We are also conducting interviews with a selected group of African American patients that have opted to participate in therapeutic clinical trials to gain a thorough understanding of the barriers and benefits they endured during their experience. The interview questions are based on prior knowledge of clinical trials, distance to facility, religious/ spiritual belief, trust of the physician, additional expenses, and time corresponded to treatment. Patients are asked to rate the importance each factor in their decision to participate and elaborate on points most specific to them. In addition, the interview allows for discussion of possible factors that challenged their participation in clinical trials which may allow for insight on low participation levels nationally. Furthermore, we are going to target patients who enrolled on clinical trials and will subsequently identify patients who did not participate in studies to identify differences in perception of treatment and clinical investigation. This project is partnered with Accounting for the High Enrollment of African Americans in Winship Cancer Institute's Clinical Trials, at Emory University.Conclusions:This study is currently enrolling patients and will answer key questions related to clinical trial participation in African American patients with lymphoma. We aim for the data collected from this study to assist in creating lymphoma clinical trials that better cater to the unique needs and considerations of African Americans. DisclosuresCohen: Genentech, Takeda, BMS/Celgene, BioInvent, LAM, Astra Zeneca, Novartis, Loxo/Lilly: Research Funding; Janssen, Adaptive, Aptitude Health, BeiGene, Cellectar, Adicet, Loxo/Lilly, AStra ZenecaKite/Gilead: Consultancy.

Diversity and Inclusion in Pancreatic Cancer Clinical Trials

Diversity and Inclusion in Pancreatic Cancer Clinical Trials

Participation of Black and Hispanic women in clinical trial evidence for NCCN preferred systemic therapies in advanced ovarian cancer

<h3>Objectives:</h3> Minority participation in clinical trials is important for expanding opportunities in access to cancer therapies and may aid in understanding racial disparities in oncology care. Prior studies have identified underrepresentation in gynecologic oncology phase I recruitment and large group trials in the United States, but minority participation specific to trials that drive current treatment recommendations remains unclear. We sought to evaluate minority participation as described in publications of curated, high quality clinical evidence for ovarian cancer therapies as identified by the National Comprehensive Cancer Network (NCCN). <h3>Methods:</h3> NCCN Clinical Practice Guidelines for Ovarian Cancer, Version 1.2020, was accessed in order to identify evidence provided for ‘preferred' primary and recurrent systemic therapies and dosing regimens in advanced epithelial ovarian cancer using explicitly listed citations. Race and ethnicity data of trial enrollment provided in publications listed as references was manually abstracted. <h3>Results:</h3> We identified 26 prospective trials including 13,887 participants, published across 5 journals: <i>New England Journal of Medicine, Lancet, Lancet Oncology, Gynecologic Oncology,</i> and <i>Journal of the National Cancer Institute.</i> All were phase II or III trials and 96% of trials were published in or more recently than 2003. Of these trials, race or ethnicity was reported in only 9 publications (35%). Of these 9 publications, there was marked language variation between trials in reporting race and ethnicity. There were 7 trials that included a description of participants as Black or African American. Of the 4,701 women who participated in these trials, 206 were Black or African American, representing approximately 4% of trial participants. There were 4 trials that included a description of participants as Hispanic. Of the 3,436 women who participated in these trials, 152 were Hispanic, representing approximately 4% of trial participants. <h3>Conclusions:</h3> Of the clinical trial evidence for preferred systemic therapies identified in the NCCN clinical practice guidelines for advanced ovarian cancer, minority participation was reported in less than half of publications and description of race and ethnicity varied between trials. Of trials that reported minority participation, Black and hispanic women represented <5% of trial participants, respectively.

Using increased trust in medical researchers to increase minority recruitment: The RECRUIT cluster randomized clinical trial

While extensive literature exists on barriers and strategies to increase minority participation in clinical trials, progress is limited. Few strategies were evaluated in randomized trials. We studied the impact of RECRUIT, a trust-based, cluster randomized minority recruitment trial layered on top of four traditional NIH-funded parent trials (BMT CTN, CABANA, PACES, STEADY-PD III; fifty specialty sites).RECRUIT was conducted from July 2013 through April 2017. Intervention sites implemented trust-based approaches customized to individual sites, promoting relationships between physician-investigators and minority-serving physicians and their minority patients. Control sites implemented only parent trials' recruitment procedures. Adjusting for within-site clustering, we detected no overall intervention effect, odds ratio 1.3 (95% confidence limits 0.7,2.4). Heterogeneity among parent trials may have obscured the effect. Of the four parent trials, three enrolled more minorities in intervention versus control sites. CABANA odds ratio = 4.2 (adjusted 95%CL 1.5,11.3). PACES intervention sites enrolled 63% (10/16) minorities; control sites enrolled one participant in total, a minority, yielding an incalculable odds ratio. STEADY-PD III odds ratio = 2.2 (adjusted 95%CL 0.6,8.5). BMT CTN odds ratio < 1, 0.8 (adjusted 95%CL 0.4,1.8).In conclusion, RECRUIT findings suggest the unique trust-based intervention increased minority recruitment to intervention trials in ¾ of studied trials. Physician-investigators' participation was critical to recruitment success. Lack of commitment to minority recruitment remained a barrier for some physician-investigators, especially in control sites. We recommend prospective physician investigators commit to minority recruitment activities prior to selection as site investigators and trial funding include some compensation for minority recruitment efforts.TRIAL REGISTRATIONClinicalTrials.govNCT01911208

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.

Race and ethnicity reporting for clinical trials in ClinicalTrials.gov and publications

Inclusion and subsequent reporting of minority participants in clinical trials are critical for ensuring external validity and detecting differences among subgroups, however reports suggest that ongoing gaps persist. ClinicalTrials.gov began requiring the reporting of race/ethnicity information (if collected) during results submission for trials in April 2017. For this study, we downloaded and compared trial race/ethnicity information from ClinicalTrials.gov submitted before (N = 3540) and after (N = 3542) the requirement date. We found that 42.0% of pre-requirement trials compared to 91.4% of post-requirement trials reported race/ethnicity information in ClinicalTrials.gov; 8.6% of post-requirement trials indicated race/ethnicity information was not collected. Use of NIH/U.S. Office of Management and Budget (OMB) classification categories was slightly higher in the post-requirement (77.1%) compared to pre-requirement (72.8%) samples. Additionally, we examined two 10% random samples of post-requirement trials – one with customized race/ethnicity reporting in ClinicalTrials.gov and the other with corresponding results publications available in PubMed. In the first random sample, 95.9% of customized categories included race information and 52.7% included ethnicity information. In the other random sample, 33.1% had a corresponding results publication, of which 62.4% reported race/ethnicity information in the publication. Among trials without published race/ethnicity information, 90.0% reported race/ethnicity information on ClinicalTrials.gov. This analysis demonstrates that the requirement has advanced public availability of information on the inclusion of minorities in research, but that further work remains to systematically ensure collection and complete reporting of race/ethnicity information.

Abstract IA01: Clinical Trial Diversity: A Perspective from the FDA Office of Minority Health and Health Equity

Abstract The U.S. Food and Drug Administration’s Office of Minority Health and Health Equity (OMHHE) aims to protect and promote the health of diverse populations though research, outreach, and communication that addresses health disparities. A key priority area for FDA OMHHE is advancing racial and ethnic minority participation in clinical trials. This presentation will provide an overview of FDA OMHHE’s efforts to advance diverse participation in clinical trials and highlight FDA policy strategies that support clinical trial diversity. Citation Format: Richardae Araojo. Clinical Trial Diversity: A Perspective from the FDA Office of Minority Health and Health Equity [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr IA01.

Not immune from disparity: Two decades of racial minority participation in immunotherapy trials for breast and gynecologic cancers

Objective: It is well established that cancer health disparities exist among minority women. While the causes are multifaceted, one theory focuses on lack of minority participation in clinical trials. Although prior studies have suggested that differences in tumor biology do exist in minority women, current enrollment protocols do not take this into consideration. Our objective is to evaluate minority participation in immunotherapy trials for gynecologic and breast cancers.

Abstract CT158: Addressing the clinical trial participation of underrepresented minorities at the USC Norris Comprehensive Cancer Center (NCCC) through the National Outreach Network Community Health Educator (NON-CHE) Program

Abstract Introduction: Certain cancer rates disproportionately affects Hispanic/Latinas, indigenous women from Latin America (Amerindians, Mayans, Mixtecs, Zapotecs, Nahua-Pipil), African Americans, and other underrepresented minorities (URMs) in Los Angeles County (LAC). Some of the barriers these minorities face such as socioeconomic status, language, and other systemic barriers cause greater disparities among them which contributes to a tendency of lower participation rates in Clinical Trials (CTs). Partnerships with the Lazarex Cancer Foundation through Project IMPACT - Improving Patient Access to Cancer Clinical Trials- were created to support the financial and patient navigation for underrepresented minority participation in CTs at USC NCCC. Currently, 68% percent of overall patients enrolled in clinical trials at USC Norris are URMs which is reflective of the USC Norris catchment area. Also, 74% percent of participants in Project IMPACT are URMs which shows the benefits of a culturally responsive approach to patient engagement. The NON-CHE program at USC NCCC focuses on a culturally and language specific based approach to increase CTs awareness and enrollment in underrepresented minorities. Methods: To foster CTs participation and to address these disparities, the NON-CHE conducts outreach, education, and engagement efforts in LAC, the catchment area of the USC Norris. Health education interventions are delivered in interactive community research meetings and their effectiveness assessed through CTs related pre-and post-test surveys and at 3-months and 6-months following attendance. Partnerships with the Lazarex Cancer Foundation/Project IMPACT will be used to recruit and refer patients to existing CTs at USC Norris. Education materials developed and culturally adapted will help convey messages in Spanish and indigenous language and in culturally appropriate ways using infographics, presentations, and focus groups to test educational/outreach materials for cultural appropriateness, literacy, and numeracy levels. Results: A total of 28 monthly outreach activities have been conducted since the beginning of the program (November 2019) with Latinx and other minority groups sharing information on cancer related programs and clinical trials at USC Norris. Conclusion: Improving access to information on CTs participation may be more effective if culture, language, and systemic barriers affecting the underrepresented minorities in the catchment area of the USC Norris are taken into account. Citation Format: Lourdes Baezconde, Juan Carmen, Carolina Aristizabal. Addressing the clinical trial participation of underrepresented minorities at the USC Norris Comprehensive Cancer Center (NCCC) through the National Outreach Network Community Health Educator (NON-CHE) Program [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr CT158.

Abstract A089: Addressing both community and institutional barriers increases accrual of minority patients in breast cancer clinical trials

Abstract Background: Clinical trials (CT) allow new treatments to become standard practice. Diversity in CT benefits both participating and future patients, but traditionally underserved ethnic/racial minorities participate in CT at lower rates than Whites. Previous studies have claimed that personal and community barriers prevent participation, but the intersection of community and institutional factors has been understudied. For the past two years, the Oncology Welcomes New Haven into Trials (OWN IT) initiative at the Yale Cancer Center has taken a multitiered approach to breast cancer minority CT accrual. Methods: Focus groups at community centers were held to better understand community perspectives on CT. Ongoing outreach was performed by physicians and community health workers at local events. Institutional barriers were addressed through executive council representation, grand rounds presentations, and didactic lectures with health care providers at multiple federally qualified health centers. Studies with eligibility criteria favorable to minority patients were opened. An anonymous, 5-minute survey was conducted at regular visits with Smilow Breast Center patients to gauge awareness of and access to CT. The survey was performed on iPads with the Qualtrics application in English or Spanish. Survey data were compared to the Yale Cancer Center Clinical Trials Office, Connecticut Tumor Registry, and U.S. Census records. Two-tailed Fisher's exact tests were used for all analysis. Results: In Sept. 2015, only 11% of 98 CT participants were minorities even though minorities accounted for 17% of breast cancer incidence in New Haven County and 16% in Connecticut. By Sept. 2017, 22% of 89 were minorities, p=0.049. Survey results confirmed a reduction in the disparity: 162 patients were asked to take the survey—12 declined, and 150 completed it. The ethnic/racial breakdown of the participants was as follows: 69% White, 10% Black, 9% Hispanic/ Latino, 3% Asian, and 9% unknown; this is in line with both the Connecticut Tumor Registry data and expected incidence based on the 2010 U.S. census. The percentage of patients invited to participate in CT and the percentage of offers declined were as follows: invited 41%, declined 19% (White); 60%, 33% (Black); 29%, 0% (Hispanic/ Latino); 25%, 0% (Asian); and 36%, 0% (unknown). There were no significant differences in invitation or decline rates between White and minority patients or between individual racial/ethnic groups. Black and Hispanic/Latino patients were significantly less likely than White patients to be aware of CT prior to the survey with only 58% confirming prior knowledge compared to 95% of white patients, p &amp;lt;.01. Conclusions: Efforts to increase minority participation in CT through institutional and community engagement were successful. Patient education regarding CT should be increased for minority patients. This approach will be used with other disease types at the Yale Cancer Center. Citation Format: Amelia A. Trant, Lucas Walz, Whitney Allen, Hannah Verma, Mindy Le, Jose DeJesus, Christos Hatzis, Andrea Silber. Addressing both community and institutional barriers increases accrual of minority patients in breast cancer clinical trials [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr A089.