The Importance of Diversity in Clinical Trials and Potential Strategies to Close the Diversity Gap
The US Food and Drug Administration (FDA) on June 6, 2019 issued a draft guidance aimed at increasing diversity in clinical trial populations. Ensuring that clinical trial participants adequately reflect the populations that will ultimately use new therapeutic products once they are approved is of paramount importance. Demographic factors such as age, race, ethnicity, and sex can affect responses to drugs and consequently affect treatment outcomes. Lacking data from diverse populations can potentially lead to overlooked differences in disease biology or impact patient safety.
This session will help identify strategies and specific actions to close any diversity gaps that may exist in the conduct of clinical trials, including:
- Educating clinical research staff on diversity issues
- Partnering with clinical sites that include a diverse mix of investigators
- Develop patient recruitment strategies include outreach to Underrepresented Racial and Ethnic Groups
- Understanding study metrics and clinical trial enrollment data
- Establishing a dedicated team of subject matter experts to promote and communicate diversity best practices