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: In your view, how has the clinical research industry responded to the recent regulatory decisions impacted by the federal government?
Lipset: I would say that for the most part, industry has been pretty silent on a lot of these decisions. One could say that industry has its own concerns to have to navigate, whether it’s around regulation and the pathways for demonstrating efficacy and safety of new medicines with FDA, or whether it’s around pricing and reimbursement, including IRA-sparked negotiations with CMS around pricing, so one would say that the industry is maybe deliberately staying somewhat silent out of maybe a perceived need to protect themselves and other interests, so you don’t see a lot of industry muscle being used to speak out or defend funding and resourcing at the FDA or NIH, as an example. I think most of many of these companies have followed the lead of others and started to modify language on their websites around diversity in clinical trials, but not all. I think we’ll start to see some separation in terms of how industry responds with regards to that commitment to representation. It’s still a mandate in Europe around diversity and representation, but the targets are very different than what our targets look like here in the US.