Areas of Focus for Clinical Operations Leaders in the Current Research Climate

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: From a clinical operations point of view, what does the industry need to focus on to ensure trials remain efficient and effective in light of some of the recent government actions affecting it?

Lipset: One theme I would say is we do need to save our sites, but in the year 2025 our attention has to be on US academic research. We can't abandon them now. We have to be a little patient with them right now, so we shouldn't start reallocating our research portfolios away from academic sites and shifting studies, in earnest, more towards private, free-standing sites, which are great ways to mix a study, for sure, but our academic sites are going to face a resourcing challenge. Many of them have hiring freezes. They're having to reshuffle a lot of their own budgets right now. It's a challenging time for them, and not a time for industry to turn away. We need them to be sustainable, and we are going to have to be an important part of that sustainability, so be patient and stay by the side of America's academic research infrastructure.

Diversity and representation investments; hopefully we've learned enough and we can continue to share enough in this space that we can be efficient in realizing representation. It still will take extra effort in planning, but hopefully we can sustain our work there, because we could do it in smarter and more efficient ways.

Certainly for clin ops friends, the regulatory environment will remain somewhat unpredictable. There are regular changes happening on websites, on nights and on weekends, and we don't have email communications or newsletters coming out that are summarizing those yet. There is a certain level of unpredictability, and that unpredictability will continue with turnover and leadership. Will turnover in leadership with the inspection community in FDA bring consequences in terms of what inspection readiness looks like? We just we just don't know yet. I would say a last call for folks will be being mindful of possible changes to Medicare and Medicaid coverage, and realizing that that has consequences for research participation. When we do coverage determinations in our protocols, and we have decided that certain procedures in the site's study budget are not going to be paid for by the sponsor, but are expected to be covered by the patient's insurance, we may have more patients who are being exposed to cost sharing or who may have coverage gaps as a result of some policy changes this year, so this is a very important year for us to make sure that we understand ways that we as sponsors can help to cover these costs, so that we are not neglecting uninsured or underinsured patients and preventing them from being able to participate in trials simply because we've done a coverage determination where we thought an expensive CT scan, MRI, or routine care chemo was supposed to be covered. We need to make sure that these patients are being kept whole, and there are some very smart and innovative folks out there that have been figuring out ways to do so.