Speaker
Adrian F. Hernandez, MD, MHS
Vice Dean and Executive Director
Duke Clinical Research Institute
Duke University School of Medicine
Keywords
Early-Phase Research; Clinical Trials; Competition; Operation TrialBlazer; First-in-Patient Trials
Key Points
- U.S. trial efficiency is declining. The country’s share of industry-sponsored early-phase research fell 9% from 2017 to 2025, and a 2025 analysis showed that cardiovascular clinical trials in the U.S. had the most sites but enrolled significantly fewer patients than those in other parts of the world. These trends suggest underlying legal, regulatory, and cost-related barriers, highlighting the need for improved clinical trial infrastructure.
- The Reagan Udall Report and Operation TrialBlazer offer hope for reforms. Academic centers need predictable activation without duplicate reviews; potential safe harbor or pooled insurance; sufficient study volume for dedicated teams and infrastructure; and performance metrics with recognition and rewards.
- Under the proposed model, serial handoffs and repeated site-by-site setup would be replaced by parallel workstreams with 1 coordinated readiness check. Successful reforms could extend to later-phase trials.
Discussion Themes
Past initiatives have cautioned that multi-component reforms risk failing if all key institutional pieces and stakeholders are not fully aligned simultaneously.
Voluntary academic cooperation may not succeed against centralized international efforts in other countries. One attendee argued for a national policy backed by government authority, central leadership, and financial incentives such as tax credit.
Transparent tracking tools and process reporting could drive friendly institutional competition and continuous quality improvement across academic medical centers.