Some of the biggest players in the drug development space worked to assure the U.S. Food and Drug Administration (FDA) they remain committed to improving diversity in clinical trial patient populations – even as they pushed back gently on a few FDA ideas on how best to proceed.
In recent comments to the agency on the FDA guidance “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs,” Novartis, Pfizer, Regeneron, PhRMA, Hoffmann-LaRoche and Genentech offered their viewpoints designed to advance the shared goal of better representing minority populations in clinical trials.
Lauding the positive impacts of mobile tools and real-time data capture, PhRMA noted it also “strongly believes that the use of real-world data/real world evidence may be a more effective and efficient means to enhance understanding of drug effects in diverse populations beyond clinical trials.”
“We’re firm believers in the power of clinical trials and the importance of bringing them to as wide an audience as possible,” said Jim Kremidas, executive director, Association of Clinical Research Professionals. “We also believe it is important to expand the actual clinical trial workforce by bringing in a more diverse talent pool as we work together to further professionalize the entire industry.”
Noting it commended FDA efforts to broaden the reach of clinical trials, Regeneron reminded the agency that recruitment “can present multiple challenges, including but not limited to:
- The identification of specific demographic or more diverse demographic populations for appropriate representation
- Identifying qualified participants for more targeted therapeutics with more precise inclusion and exclusion criteria (IC/EC)
- Determining specific target ranges of clinically relevant populations
- Limitations on the generalizability and applications of results to larger populations
While the general thrust of the comments was supportive, industry did ask FDA to provide more information or clarity in some instances regarding its expectations. For example, Novartis asked the agency to “include a list of specific diseases which are prone to underrepresentation” in clinical trials.
Author: Michael Causey