ACT Brief: Targeted Trial Growth, Site Startup Strains, and Leadership Shake-Up at FDA

This is the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations. In under three minutes, we’ll recap top stories, highlight expert perspectives, and keep you current on what’s moving the industry.

In a new ACT video interview, Citeline’s Heidi Chen says the rise of biomarker-driven and personalized therapies is reshaping how trial designs are planned—but not replacing traditional large randomized studies. While niche patient populations present logistical hurdles, single-arm trials using historical controls and real-world evidence are helping advance targeted programs. Chen notes that Phase II and III trial starts saw strong growth in 2024, reflecting encouraging progression through early-phase attrition points.

New survey data from ICON shows that clinical trial sites continue to face major bottlenecks during study startup. More than half of sites now wait over five months from selection to activation, driven largely by contract and budget negotiations. Site leaders say communication gaps with sponsors and CROs remain a persistent pain point, underscoring the need for more collaborative, responsive startup models.

And at FDA, CDER director Richard Pazdur, MD is set to retire by the end of the month, leaving vacancies at both the drug center and the Oncology Center of Excellence. Reports suggest frustrations with political interference and concerns around the Commissioner’s National Priority Voucher Program influenced his decision. FDA leadership praised his 26 years of service and longstanding impact on oncology and cross-center regulatory innovation.

That’s all for today’s ACT Brief. Join us next week for more updates shaping clinical operations and drug development. Thanks for listening.