ACT Brief: Enrollment Feasibility Pressure-Testing, RWE Infrastructure Gaps, and Peptide Rulemaking Standstill

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

• In part three of her interview, Claire Riches, VP of clinical solutions at Citeline, explains why combining analog trial performance data with real-world patient data and site-level recruitment history gives sponsors a far more honest picture of whether their enrollment assumptions are actually achievable. Data inputs matter most when they are diverse, independent, and specific to the protocol and population being tested.
• In a new feature article, we examined how real-world evidence is moving upstream into trial design and regulatory submissions faster than sponsors have built the infrastructure to support it. Data quality, integration, and organizational alignment required to make evidence regulatory-grade are still catching up to the ambition, leaving gaps between what organizations want to do and what their systems can actually deliver.
• In a new feature from Pharmaceutical Executive, content associate Nicholas Jacobus described a widening disconnect between the FDA's rulemaking process, which is advancing a narrow regulated path for select compounded therapies, and its enforcement arm, which is already taking action against sellers who did not wait for formal guidance. The advisory process has recommended six therapies for potential inclusion on an approved list, but enforcement has proceeded independently, creating uncertainty about what is and is not permissible in the interim.

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