P106: Exploring the Role of Federal and Sponsor Expectations in Diverse Recruitment Practices: Implications for Stakeholders
Director, Clinical Trial Recruitment
Sun Pharma Advanced Research Company (SPARC) United States
The purpose of the study was to understand the federal and sponsor policy elements that are involved in the active implementation of racially and ethnically diverse recruitment practices for biopharmaceutical-funded trials in the United States.
The research design was a descriptive, exploratory qualitative study utilizing in-depth interviews conducted Nov‘18–Mar‘19. Purposeful sampling was used to recruit research staff to provide their experiences with recruiting diverse trial participants in relation to federal and sponsor expectations.
For this study, policy was defined as national, state or local laws as well as clinical trial policies. This included items such as government regulations on clinical trials; federal guidance and expectations related to clinical trial conduct; policies or expectations set forth by the trial funder; and the healthcare system. Participants in this study discussed the following related to policy:
•Sponsors or governing bodies are not setting expectations to enroll specific subpopulations or emphasizing inclusive enrollment in practice, demonstrated by a lack of diversity focus during site selection; lack of diversity in site staff on study teams; lack of appropriate recruitment support; and lack of centralized educational efforts to raise awareness of clinical trials
•Research sites are not held accountable to enroll representative trial populations
•Sponsor focus is on general recruitment and not specific goals by subpopulation
•Participants were motivated to meet the enrollment goal commitment made to the study sponsor
•Nearly half of the participating organizations did not set recruitment goals for racial and ethnic groups (47%)
•Over half of the participating organizations (53%) did not require staff to take cultural competency training
•Participants discussed a recent shift in the trial landscape, suggesting a trend toward more emphasis being placed on the importance of having meaningful representation. This was also discussed in relation to failed attempts to meet diversity goals in clinical trials and sponsors demonstrating a lack of understanding of effective recruitment practices and tactics
•On occasions when expectations related to diversity were put in place, research sites were influenced to focus on diverse recruitment
•Healthcare system structure related to lack of diverse Investigators and lack of diverse healthcare workers were reported as barriers
•Participants offered clinical trials as a care option to patients without health insurance
Participants in this study were less influenced by expectations of pharmaceutical sponsors or the FDA and were more focused on fulfilling contractual agreements and overall recruitment goals. Support provided by sponsors was often inadequate and provided on a study-by-study basis. Participants discussed broader site-initiated efforts to engage with diverse communities related to research, likely fueled by the scarcity of centralized approaches. Yet, participants displayed a strong sense of obligation to deploy inclusive recruitment practices when diversity expectations were put in place. Findings suggest that if trial sponsors expand expectations for enrollment to reflect disease prevalence, research site staff may be motivated to enhance inclusive recruitment efforts.
Implications: Racially and ethnically diverse populations have historically been underrepresented in clinical trials, despite being recognized by the NIH and FDA as critical for ensuring approved products are safe and effective in all treatment populations. Guidance set forth by the FDA to enroll clinically relevant trial populations could be addressed by initiating action across stakeholders who drive expectations and policy related to trial conduct. Rather than enact federal mandates for industry-funded trials, a call to action is recommended for clinical research stakeholders including:
•Federal Organizations (e.g. FDA OMH): Deploy programs to generate awareness among healthcare professionals on the importance of ensuring representative trial populations •Trade Associations (e.g. PhRMA): Generate funding from member organizations to deploy a national clinical trial public awareness campaign to reach diverse communities •Biopharmaceutical Sponsors: Hold research sites accountable for meeting demographic subgroup enrollment goals by incorporating into contracts •Contract Research Organizations: Embed site feedback mechanisms regarding effective engagement practices for diverse communities