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: Clearly, this is a very polarizing time politically for a lot of folks, but I think objectively, most would say that efficiencies are needed, and that would be a good thing. We want our public research dollars to make the greatest possible impact, but it does feel like many of the actions to date have been, the visual is more chainsaws than scalpels. We see things being targeted, like the role of overhead with NIH funding of academic research and that seems like an easy target just to go after, but it has tremendous consequences. Overhead in academic research supported by the NIH supports intramural research, those research initiatives that are being funded by the universities themselves, that often provide the seeding of what future research we want to go after, those are often the higher risk, smaller things to go after. Overhead supports our shared infrastructure, our labs, our technical equipment, and other shared resources that you couldn’t put as a line item into just one direct budget, one set of direct costs for a grant, so there’s tremendous consequences, and it is painful for many of us to see that ripple effect in terms of PhD acceptances being rescinded for a next generation of research scientists, and certainly for a lot of the staffing and resourcing, even just within the FDA and the NIH.