Addressing Current Regulatory Challenges with Diversity in Clinical Trials

In a recent video interview with Applied Clinical Trials, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discussed the impact of recent regulatory decisions on clinical research. Funding cuts by the NIH will affect intramural research and shared infrastructure. Additionally, the politicization of diversity initiatives will affect the enforcement of action plans. Lipset also highlighted the industry’s response to these actions and what it can expect moving forward.

ACT: What was your initial reaction to some of the most recent regulatory decisions impacted by the federal government such as NIH funding cuts and the FDA removing its diversity webpages?

Lipset: I know you're also asking about the impact around clinical trial diversity and as we see websites coming down with certain language, in some ways, maybe it's all of our fault, right? Maybe we shouldn't have been calling this clinical trial diversity in the first place. Maybe over the last year, seeing some of the politics around the term diversity, we should have taken the warning and started to refer to this more around representation and research, because representation in research is more scientific than social and is certainly something that many of us can back and defend. Now, I think for those that follow the confirmation hearings with the likely incoming FDA commissioner, it was nice to see some reassuring messages from him about clinical trial diversity and representation. Now, I have some friends that will say, this is codified, this is law, diversity in clinical trials, so therefore it will persist, but I think for those folks, I would encourage them to read the law and read what the draft guidance has to say. Companies have to create diversity action plans. The FDA doesn't have to take action based on a diversity action plan, so there is discretion within an administration in terms of what kind of action or consequences there would be if a milestone in a diversity action plan is not realized. In some of the draft guidance language, it might mean that one has to do more real-world evidence gathering to understand other populations, but the consequences, at least in the United States, aren't hard coded with drastic penalties, so there is a fair amount of discretion to be had there.

I do fear personally, that without a regulatory mandate, a lot of our investments and commitments related to trial diversity will slide backwards, enrolling representative patients costs money and takes time, and as a shareholder-fueled industry where pharmaceutical and biotech companies have responsibilities to shareholders and how they use their dollars, will that entire community continue to believe that putting dollars into representation and allowing more time for more representative patients to be enrolled is the right way to use their shareholders’ resources, if there is not a regulatory mandate to do so, as compared to allocating those dollars in other places. I think we'll start to see separation out there where some companies, perhaps maybe those more out of Europe or in other pockets, will maintain that commitment, and others will slide back.