ACT Brief: Who Sets Trial Endpoints, Human-Centered Trial Execution, and Bladder Cancer Approval Expansion

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

• In Episode 3 of The Human Side of Clinical Trials, Brian S. McGowan, PhD, and Kelly Ritch of ArcheMedX speak with Jason Riis, PhD, CEO of Behavioralize, about why a well-written protocol doesn’t always translate into consistent execution. Designing for how people actually think and learn can reduce site burden and the need for costly unlearning. The discussion recommends testing protocols under realistic distraction and uncovering misperceptions early.
• A new ACT FAQ article examines who decides what clinical trials measure. Endpoints are shaped mainly by expert clinical teams, regulatory precedent, and analytical convention, while patients and caregivers are rarely the ones defining success. That gap is now showing up in post-approval evidence, regulatory submissions, and protocol design.
• The FDA expanded approval of ImmunityBio’s Anktiva plus BCG to a specific bladder cancer subtype that no longer responds to BCG, nearly three months ahead of its target date. Rather than new trial results, the agency extrapolated efficacy from a related patient group in the QUILT-3.032 trial, where 62% of 77 patients achieved a complete response. The company’s announcement does not present separate efficacy data for the newly added subtype, which ImmunityBio says accounts for about 85% of non-invasive bladder cancer cases.

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