Director, Advanced analytics and Research optimization Advarra, United States
Background: To create safe and effective therapies for all races, ethnicities, and genders, clinical studies must include diverse participants. The U.S. Food and Drug Administration (FDA) released draft guidance to improve clinical research diversity. The Institutional Review Board’s (IRB) role in clinical trial inclusivity and addressing social inequities is equally important.
Methods: Sponsors, clinical research organizations, and site organizations in the United States that follow the April 2022 FDA draft guidance to improve trial enrollment of underrepresented racial and ethnic populations were surveyed about inclusive research practices and clinical trial diversity. This SurveyMonkey survey was created and distributed to social and marketing networks from April 13 to May 19, 2023. RStudio (2022.07.2 Build 576) and R (4.2.1) examined the responses.
Conclusion: The survey, conducted by Advarra and Acclinate from April 23 to May 19, 2023, gathered 335 responses from sponsors, CROs, and site organizations. 57% responded based on their department’s portfolio, and 42% on their organization’s full portfolio. 31% had not submitted diversity plans since 2022, while 26% submitted at least one. Topics included familiarity with diversity efforts, compensation strategies, telemedicine use, site training, and community partnerships. The survey emphasized U.S.-specific efforts, focusing on underrepresented groups such as Black, Hispanic, Indigenous, Asian, and Pacific Islander populations. While 39% believed diversity efforts improved relationships with these groups, 26% were unsure or disagreed, indicating the need for better measurement tools and trust-building. Though organizations are committed to promoting diversity, challenges persist in ensuring equitable representation. Ongoing efforts in engagement, training, and measurement strategies are critical to advancing the impact and inclusivity of clinical trials.
Limitations: Our survey's limitations should be considered when interpreting its findings. It is unknown whether the values in this convenience survey represent the broader clinical research community. In addition, the analysis lacked a long-term assessment of the impact of diversity initiatives on clinical trial outcomes, such as the generalizability of results or the development of tailored interventions for diverse populations. These alternative counterarguments and additional considerations can help clarify clinical research diversity, equity, and inclusion issues.
Discussion: The data highlights incremental progress in clinical trial diversity but emphasizes the need for stronger trust-building and community engagement efforts. While many organizations are committed to diversity, measuring the effectiveness of these efforts remains a challenge. Future initiatives should prioritize long-term investments in training, recruitment, and inclusive trial designs. DE&I offices can partner with IRBs and researchers to reduce bias, develop inclusive consent processes, and monitor diversity metrics. Collaborations will ensure clinical trials align with both ethical standards and community needs, fostering sustainable participation and improving the relevance of clinical research outcomes.
