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|September 28, 2026
ACT Brief: AI Expands Endpoint Options, CRO Oversight Documentation, and Kidney Cancer Approval
Author(s)Andy Studna, Senior Editor
In today's ACT Brief, we examine how AI is surfacing endpoint options beyond traditional design thinking, why sponsor oversight of outsourced work often fails on inspection despite being robust in practice, and a new combination drug for advanced kidney cancer.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- In
part one of a new interview , Claire Riches, VP of clinical solutions at Citeline, explains how AI is expanding endpoint selection beyond the bounded experience of a single sponsor team. AI surfaces options that traditional design thinking might never have considered, enabling sponsors to evaluate endpoints they might otherwise have overlooked and make more informed decisions about what to measure. - In a
new contributed article , Caroline O'Connor, chief commercial officer of TRI, examined why sponsor oversight of outsourced CRO work is often robust in practice but fails inspection because oversight decisions are fragmented across systems and lack an audit trail. Regulators expect clear documentation of CRO qualification, risk assessment, performance reviews, issue resolution, and escalation pathways from study start to close-out, creating a connected record that is durable and traceable. - The
FDA approved a combination treatment for advanced kidney cancer after patients progress on prior therapies , based on the Phase III Litespark-011 trial showing 747 patients experienced 14.6-month median time before disease progression or worsening compared with 10.6 months on the standard treatment. The study also showed a 53% response rate with the combination versus 40% on the comparison drug, while overall survival, the trial's other main goal, did not reach statistical significance.
That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.
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