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 The U.S. Food and Drug Administration (FDA) released draft guidance to improve clinical research diversity.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Sponsors, clinical research organizations, and site organizations in the United States that follow the April 2022 FDA draft guidance to improve trial enrollment of underrepresented racial and ethnic populations were surveyed about inclusive research practices and clinical trial diversity.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.
Results: The findings suggest a recognition of the importance of diversity in clinical research, with varying degrees of implementation and perceived effectiveness of diversity initiatives across different organizations. Most respondents reported being familiar or somewhat familiar with their organization's diversity initiatives. However, respondents showed less confidence in the effectiveness of these efforts in building stronger relationships with historically excluded and underrepresented populations. This indicates that while there is notable commitment within the clinical research community to promoting diversity, there is a growing recognition of the importance of ongoing engagement and fostering trust among community members, patients, healthcare providers, and research sponsors. Measuring and conveying the impact of diversity efforts in clinical trials on enhancing relationships with historically underrepresented populations can be particularly complex. When questioned about whether organizational initiatives have positively influenced relationships, less than half of respondents agreed to any degree (39%), while 26% expressed disagreement or uncertainty. These responses suggest the possibility that effective tools for measuring impact may be underused or not fully developed. In conclusion, while there is clear progress in recognizing and addressing DE&I issues within clinical research, there remain opportunities for further enhancement of diversity initiatives, training programs, and engagement strategies to ensure equitable representation and participation across all demographic groups. Continued efforts and investment in fostering diversity and inclusion are essential for advancing the integrity, relevance, and impact of clinical research endeavors.
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: Diversity, equity, and inclusion (DE&I) in clinical research is a broad topic that requires formal investigation. Most clinical research organizations have provided training or education to their staff members regarding the importance of diversity in clinical trials however, it may be necessary to explore new approaches for evaluating the impact of diversity initiatives, as well as identifying innovative strategies for enhancing relationships with underrepresented populations in clinical research. Organizations should prioritize diversity training and education relevant to clinical trials for all personnel involved. Commitment to continuous improvement and adjusting strategies can help enhance the representation of diverse populations.
