In today’s ACT Brief, we examine who decides what trials measure, how designing for human thinking improves site execution, and how the FDA extended an immunotherapy to a new bladder cancer population.
News|Podcasts|July 2, 2026
ACT Brief: Selective Safety Data and Visit Reduction, Protocol Design Execution Gaps, and China Trial Security Investigation
Author(s)Andy Studna, Senior Editor
In today's ACT Brief, we examine quantified reductions in trial visits through selective safety data collection, why protocol failures occur during operational transition, and congressional investigation into pharmaceutical company trials in China.
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.
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