In today's ACT Brief, we examine what patient-site relationships need beyond easier technology, how to build defensible rare disease evidence from scratch, and how real-world data and AI improve enrollment screening accuracy.
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.
Related to this article
In today's ACT Brief, we examine why defensible trial data depends on traceability and platform ownership, what CGT site readiness requires as therapy moves to community care, and why data harmonization is AI's primary bottleneck.
In this episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Cecilia Xi, PhD, VP of clinical and scientific affairs at Vivalink, about why defensible trial data depends on traceability, platform ownership, and device strategy long after a study ends.
In today's ACT Brief, we examine understanding the patient journey from end to end, whether decentralization reduces site burden or just shifts it, and why nine European drugmakers are sounding urgent alarms.
In today's ACT Brief, we examine technology's real role in patient-site collaboration, why AI pilot failures stem from organization not innovation, and Novo's weight-loss drug results in competitive comparison.
In today's ACT Brief, we examine what patient-site relationships need most at DPHARM, how platform-based AI scales across workflows, and FDA's approval of a gene therapy for a rare childhood syndrome.
In today's ACT Brief, we examine what genuine patient voice requires beyond buzzwords, why AI's next bottleneck is system integration not models, and how regulators across three jurisdictions are formalizing patient input requirements.
In today's ACT Brief, we examine FDA's expedited pathway for first-in-human trials, why operating model design matters more than sourcing strategy, and how early readiness signals predict trial risk.
Trending on Applied Clinical Trials Online
1
When There’s No Registry: Building Rare Disease Evidence That Supports Regulatory Scrutiny
2
How AI Is Changing Endpoint Selection Before a Trial Even Starts
3
Sponsor Oversight in an Outsourced Trial: What Good Looks Like and How to Evidence It
4
ACT Brief: AI Expands Endpoint Options, CRO Oversight Documentation, and Kidney Cancer Approval
5