PhRMA Supports Diversity in Trials, Balks at Mandates
Diversity is a critical area in clinical research that desperately needs to be improved, the pharma industry agrees, but policies that would require sponsors to enroll more diverse populations will only backfire, contends industry trade group PhRMA.
The House Energy and Commerce Committee’s Health Subcommittee met Thursday to discuss several bills aimed at spurring trial innovation and improving oversight, some of which call on the FDA to set specific requirements for the racial, ethnic and gender makeup of trials.
Lucy Vereshchagina, vice president of science and regulatory advocacy at PhRMA, testified that while the trade group is supportive of improving diversity in trials and is taking action itself, it’s unwise to enact diversity policies that would burden sponsors with more requirements. Doing this would have repercussions on clinical research and innovation, PhRMA claims.
Rather than imposing requirements on sponsors, PhRMA believes that all stakeholders should come to the table to discuss the lack of diversity in trials and push for a community-based solution that helps bring underserved patients into trials.
A recent analysis done by researchers at the Memorial Sloan Kettering Cancer Center found that a five-year diversity action plan run by the FDA had made little difference for Black patients (CenterWatch Weekly, March 14). With the strategy not achieving its desired results, the researchers believe the FDA should think about implementing “representational requirements” that go beyond trial reporting and transparency measures.