Resource Reallocation in Clinical Research

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: How are the recent regulatory decisions impacted by the federal government impacting the clinical research industry?

Lipset: I think when we think about how these decisions are impacting the clinical research industry today, I think we already see a number of companies that are reallocating resources away from vaccine and vaccine drug development. Some are reporting delays and review times with staffing implications at FDA. We're seeing that FDA leadership in domestic as well as international collaborations, is becoming absent because those leaders aren't able to go and participate, so some of those initiatives will have leadership voids filled by representatives from Europe, Japan, and China, bringing their perspectives to leadership and setting those future strategies. I think, though, there is this consequence for us around which of our research sites need saving, right? We see a lot of rhetoric on social media of saving sites, but very often, the sites that are most prominent in those conversations are private, standalone sites, I would argue, in 2025 the sites that need saving will be the academic research sites who are struggling the most as a consequence of some of the policies.