Clinical Operations Teams Adjust to Evidence and Engagement Gaps

In a recent video interview with Applied Clinical Trials, Charlie Paterson, partner at PA Consulting, discussed how reduced FDA capacity and significant staff turnover in 2025 have reshaped regulatory engagement and operational planning for clinical trials. Paterson explained that sponsors are facing longer timelines for meetings and decisions, prompting greater upfront investment in submissions and more conservative planning. He also outlined how slower FDA guidance is influencing trial design choices, limiting adoption of innovative approaches, and driving sponsors to rely on precedent and non-US regulatory frameworks. The conversation explored where regulatory uncertainty is most acute across the development lifecycle and how evolving risk tolerance at the FDA could further globalize clinical trial strategies.

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

ACT: How should clinical operations teams adjust expectations around scientific advice and agency engagement this year?

Paterson: We’re already seeing a slower pace of guidance issuance at multiple levels. Innovative designs like platform and adaptive trials have been widely discussed, and guidance from other agencies supports their benefits in reducing cost and time.

But without guidance in the market, we’re not seeing the level of adoption many hoped for. The same applies to decentralized and hybrid trials, digital endpoints, and wearables. Technically, we’re ready to deliver trials at scale, reach diverse populations, and lower barriers to entry—but we’re not able to do it at the required pace.

Organizations don’t want to take the risk of designing novel trials if they can’t get feedback during pre-IND development that ensures results will be accepted. That hesitation continues to shape operational decisions.