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    The FDA Provides New Guidance on Enhancing Diversity in Clinical Trials

    By Daniel Palestrant, MD • December 3, 2020
    FDA Guidance on Diversity

    The FDA has again weighed in on diversity in clinical trials. Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry is a final version of a draft guidance the Agency released in 2019. The most recent guidance, which this article summarizes, was issued last month. Overall, clinical trial sponsors should consider trial design and methodological approaches that will facilitate enrollment of a broader population. These are the recommended approaches:

    • During the study design, consider the recruitment challenges that may occur because of the planned visit schedule and difficulties with accessibility to trial sites: reduce the frequency of study visits to those needed to appropriately monitor safety and efficacy, and consider whether flexibility in visit windows is possible and whether electronic communication (e.g., telephone/mobile telephone, secured electronic mail, social media platforms) or digital health technology tools can be used to replace site visits.
    • Employ mobile medical professionals, such as nurses and phlebotomists, to visit participants at their locations instead of requiring participants to visit distant clinical trial sites. 
    • Implement more inclusive strategies for public outreach and education, such as incorporating patient-focused research into clinical trial design. Industry, patient advocacy groups, medical associations, and other stakeholders can consider collaborating to educate participants about clinical trial participation. 
    • Work directly with communities to address participant needs and involve site coordinators, patients, patient advocates, and caregivers in the design of clinical trial protocols in order to determine which elements of the protocol may discourage participation and how the study can be optimally designed to enhance recruitment
    • Foster community engagement through medical societies, focus groups, community advisory boards, disease registries, and community-based participatory research, the latter of which promotes the design of clinical research with the assistance of community members and leaders to more effectively meet the needs of potential participants.
    • Remain engaged with communities after the conclusion of the trial and share trial updates to continue to strengthen relationships with communities.
    • Provide cultural competency and proficiency training for clinical investigators and research staff to help facilitate trust with participants, provide a helpful resource for investigators and research staff on how to engage with participants with different backgrounds, help decrease biased communication and behavioral practices, and help avoid the use of cultural generalizations and stereotypes in interactions with participants.
    • Include geographic locations with a higher concentration of racial and ethnic minority patients, as well as locations within the neighborhoods where these populations receive their health care, because restricting clinical trial sites to selected geographic locations may limit the ability to enroll a diverse trial population.
    • Consider diversity when selecting health care providers and study coordinators to assist with clinical trial recruitment as participants may prefer a health care provider of the same cultural background.
    • Make recruitment events accessible by holding them often, as well as during evening and weekend hours. Consider holding events in trusted locations such as places of worship or community centers and at social commercial venues such as barbershops and beauty salons. Also consider public events such as cultural festivals, carnivals, and parades as a means of connecting with diverse populations.
    • Provide trial resources and documents in multiple languages and multilingual research staff and/or interpreters in order to encourage the participation and retention of individuals with limited English comprehension.  
    • Consider online/social media recruitment strategies to identify participants for whom a traditional referral center is not accessible.
    • Consider “electronic informed consent” to allow participants to read and sign necessary forms remotely instead of traveling to a clinical trial site, while ensuring that all potential participants, including those with literacy issues, understand all necessary information. 

    FDA Resources to Explore
    Note that the FDA’s Office of Minority Health and Health Equity provides a web page for racial and ethnic minority and underrepresented consumers that contains a clinical trial diversity toolkit, a webinar, multilingual fact sheets, videos, and links to relevant resources. Explore the offerings here.

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