Abstract A66: Recommendations to address common barriers to diversity in oncology clinical trials: An industry perspective

Introduction: Racial and ethnic minority enrollment in clinical trials is still a challenge and current recruitment planning has failed to improve diverse representation in clinical trials. The following literature review identified common barriers to diverse trial enrollment resulting in suggested tactics to address these barriers for breast cancer clinical trials. Methods: A literature review was conducted to identify barriers to oncology clinical trial enrollment for African American, Hispanic, Asian American, and Native American populations. A targeted review of barriers for patients in the lower socioeconomic status (SES) bracket was also performed. An advisory board of study coordinators was consulted to assess site–level awareness, barriers, and resources needed from the pharmaceutical industry. Additionally, ongoing initiatives were assessed including use of a Latino toolkit, patient navigators, and community outreach strategies. Results: The number of evidence based recruitment strategies targeting ethnic minorities was found to be lacking. There are four key aspects that influence diverse patients9 decisions to participate in trials: family/friends, finances, faith, and physicians/staff. Barriers identified affected a majority of the analyzed patient populations. These included: protocol inclusion/exclusion criteria; logistical concerns; few incentives for participating; and cultural factors. The informed consent form and process were cumbersome and not patient-centric; costs related to travel and co-pays, and mistrust of medical research and the pharmaceutical industry were also identified as common barriers. The primary barriers were lack of invitations and lack of awareness at multiple levels within medical institutions, health care professionals, communities, and the pharmaceutical industry. Suggestions to address enrollment barriers include education to increase awareness, a patient-centric approach to consent and trial discussions, and tailoring site selection strategies. Other suggestions are immersion into communities, patient reimbursement, cultural competency training, pro-active translations, early recruitment planning, and identifying processes for approaching non-English speaking patients. Epidemiology data should also be incorporated in planning to establish baseline and enrollment goals. Conclusion: Although each of the analyzed populations is unique, common themes emerged. A patient-centric approach to increasing diversity in clinical trials should include considering a patient9s key influences, addressing common concerns, conducting a properly informed consent process, and empowering a patient9s decision making process. Gaps in current recruitment practices do still exist and further research on evidence based diverse recruitment strategies is also needed. Citation Format: Kelly R. Kirsch, Gebra C. Carter, Jacqueline M. Cole, Allicia C. Girvan, Coleman K. Obasaju. Recommendations to address common barriers to diversity in oncology clinical trials: An industry perspective. [abstract]. In: Proceedings of the Sixth AACR Conference: The Science of Cancer Health Disparities; Dec 6–9, 2013; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2014;23(11 Suppl):Abstract nr A66. doi:10.1158/1538-7755.DISP13-A66