ACT Brief: RWE Refines Trial Design, Oncology CRO Scale Expands, and Feasibility Pressures Persist

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

• In the final part of an Applied Clinical Trials interview, Inovalon’s Jen Lamppa says the growing use of de-identified real-world evidence is making trials smaller, smarter, and more efficient—not obsolete. She points to hybrid designs, smaller control arms supported by external comparators, and fewer large post-market studies, alongside greater reliance on continuous real-world monitoring. Lamppa emphasizes that RWE is augmenting traditional trials, particularly for low-risk or mature products, rather than replacing them.
• Worldwide Clinical Trials has entered a definitive agreement to acquire oncology-focused CRO Catalyst Clinical Research, strengthening its early- and late-phase oncology capabilities and expanding functional service provider offerings. The deal brings together Catalyst’s early phase oncology and biometrics expertise with Worldwide’s global scale and late-phase strengths. The combined organization aims to support larger, global oncology trials while maintaining flexible, high-touch delivery models, with the transaction expected to close in the first quarter of 2026.
• New data highlighted in an article from AJMC show that feasibility, enrollment, and early trial termination remain persistent challenges despite advances in analytics and AI. A Phesi analysis of nearly 66,000 recruiting trials found that Phase II attrition remains elevated, competition for patients continues to intensify in the US, and increasing protocol complexity is narrowing eligible populations. Experts say AI-driven feasibility modeling and real-world data integration are becoming essential to designing trials that can realistically enroll, execute, and generate meaningful evidence.

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