ACT Brief: Selective Safety Data and Visit Reduction, Protocol Design Execution Gaps, and China Trial Security Investigation

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• In part two of his interview, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, broke down CTTI research showing 50 to 75% reductions in visits and assessments using selective safety data collection on mature assets. These data-driven reductions maintain safety oversight rigor while meaningfully lowering participant burden and operational complexity.
• In a new contributed article, Elizabeth Walsh examined why protocol design failures emerge not during protocol development but during transition to trial execution, when untested assumptions about patient populations, visit schedules, and vendor scope meet operational reality. Early engagement of interpretive operational expertise during feasibility and study design is required to translate scientific intent into workable procedures before commitments harden into expensive amendments and delays.
• A bipartisan House committee launched national security investigations into Merck, AbbVie, Eli Lilly, Pfizer, and Bristol Myers Squibb over clinical trial operations in China, citing intellectual property exposure risks and military hospital affiliations. The companies must respond by July 17 on due diligence processes and data protection standards.

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