Filling the Void for Clinical Research Leadership Amidst Political Headwinds

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: Outside of organized companies responding, we are seeing how people are responding, how they're self-organizing to fill some of these gaps, and I think that's been something really exciting to see. When ARPA-H, which is a very innovative part of HHS, started to cancel what they were calling Proposers’ Days for some of their initiatives, one in particular for an initiative called RAPID, which focuses on using artificial intelligence to improve diagnostics and rare diseases, a great use case for AI, but where there are Proposers’ Days for new work was suddenly canceled because of the communications hiatus that was put out across HHS, the people that were planning to attend the meeting met themselves and rapidly self-organized their own meeting. When the NIH and FDA had to quickly cancel their Rare Disease Day on short notice because of this communications hiatus right now, communities started to form their own rare disease events on that day in Washington with 24, 48, 72-hours’ notice. We see the same thing happening again and again. When the CDC had canceled with short notice the February ACIP meeting, which is where experts in infectious disease determine what's trained to target for the next year's flu vaccine manufacturers, experts in the infectious disease community, together through their society, the Infectious Disease Society of America, they convene their own mini ACIP meeting, so it's interesting to watch communities start to self-form, to fill some of these gaps where typically we've had great leadership and convening power from the federal government. It will be great to see that restored. Hopefully we'll start to see communications open up again with our colleagues in Washington, but in the absence it's fabulous to see how communities can self-organize.