Clinical Trial Site Perspectives and Practices on Study Participant Diversity and Inclusion

Abstract

Clinical trial participant populations fail to adequately represent target populations that drugs are intended to serve. Improving racial and ethnic diversity of clinical trial participants is essential for generalizable, quality clinical research results and ensuring social and medical equity. Site-level clinical research professionals (CRPs) have unique insights on diversity improvement strategies for clinical trial enrollment. A survey was distributed to current CRPs working at clinical research sites in the United States to describe current practices and perceptions of the impact these practices have on participant diversity. Subsequently, descriptive quantitative analysis and inductive content analysis were performed. For the practices surveyed, there are discrepancies between frequency of use and perceived impact on diversity enrollment. Common current practices include phone-based or telemedicine study visits, electronic/digital data collection, and participant compensation. However, we report travel reimbursement and services, translated documents and translator services, and adequate participant compensation as most impactful on diverse enrollment. A multistakeholder approach is necessary to enhance diversity and inclusion (D&I) of study participants. Besides large-scale solutions such as countering community distrust, actionable steps are needed by sponsors and study sites to improve D&I of trial participants. Study leadership at the sponsor, contract research organization (CRO), and site-level should create diversity plans prior to study start, and CRO and sponsor budgets should consider D&I strategies during study planning. Planning should incorporate strategies to improve D&I including adequate participant compensation, translated documents and translator services, and travel reimbursements.

A Primer for Culturally Attuned Psychedelic Research

“…To improve the retention of such individuals in psychedelic clinical trials, study team members need to provide and communicate detailed study policies regarding the non-reporting of undocumented status, and may need to enlist the aid of community-based groups or language brokers (i.e., first-generation children of migrants) trusted by the migrant communities to help guide these conversations (Hussain-Gambles et al, 2004;Morales & Hanson, 2005). A detailed review of how to bridge the language gap is beyond the scope of this paper; interested readers are advised to consult MacLennan et al (2023).…”

“…As mentioned, transportation is a major barrier to accessing healthcare, particularly among members of marginalized and low-socioeconomic status communities (Syed et al, 2013), many of whom tend to be Black, Brown, and/or queer. A direct solution is to utilize convenience-enhancing technologysuch as ride share app creditsto improve transportationrelated accessibility (Hussain-Gambles et al, 2004;MacLennan et al, 2023). Equitable monetary compensation for participation in general, on top of reimbursing transportation, is also an attractive, non-coercive, and most importantly, sensitive and respectful answer to competing responsibilities (e.g., part-time jobs, shift work) that may detract from participating in and fully benefiting from clinical research (Hussain-Gambles et al, 2004;MacLennan et al, 2023).…”

“…A direct solution is to utilize convenience-enhancing technologysuch as ride share app creditsto improve transportationrelated accessibility (Hussain-Gambles et al, 2004;MacLennan et al, 2023). Equitable monetary compensation for participation in general, on top of reimbursing transportation, is also an attractive, non-coercive, and most importantly, sensitive and respectful answer to competing responsibilities (e.g., part-time jobs, shift work) that may detract from participating in and fully benefiting from clinical research (Hussain-Gambles et al, 2004;MacLennan et al, 2023). Equitable compensation can also be helpful to offset some of the costs that may be associated with negotiating child care as participants consider taking time off work or finding external assistance to take care of their children as they attempt to attend study visits.…”

Diversity, Equity, and Inclusion: Translating Clinical Pharmacology for All

“…The authors discuss community engagement, site selection strategy, patient‐centered approaches to communication, and breaking barriers to participation as key enablers, in resonance with several of the recommendations offered through insights from CTTI's qualitative research, 22 the roadmap presented by Washington et al ., 23 and MacLennan et al . 's 25 survey of site‐level clinical research professionals. Regulatory frameworks that nurture DEI are the subject of two mini‐reviews in this issue of CPT .…”

Simplifying informed consent as a universal precaution

“…Although anyone can have low health literacy at any time depending on the situation (e.g., are afraid, anxious, fatigued, sick, or have just gotten a new diagnosis) 23 the high prevalence of disadvantaged populations who have low health literacy may mean that people who are representative of those populations may not sign up for clinical trials 20 , 22 . Thus, improving understandability of ICD may improve participant accrual and facilitate inclusivity of diverse research populations with health literacy challenges 4 , 5 , 7 , 12 , 16 , 17 , 24 , 25 .…”