ACT Brief: ESG Moves Into Vendor Oversight, RWE Faces Governance Hurdles, and Roche Advances Obesity Pipeline

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

• In a new ACT contributed article, Otis Johnson argues that ESG initiatives in clinical development often fail when treated as parallel reporting exercises rather than operational signals. He says emissions, patient burden, and supply chain impacts are driven by trial design and vendor delivery models, making vendor oversight the most practical integration point. Johnson outlines how decision-grade ESG metrics can be embedded into existing qualification, governance, and corrective action processes without expanding GCP requirements.
• In part four of an ACT interview, Inovalon’s Jen Lamppa says broader regulatory use of de-identified real-world evidence is still constrained by data quality, linkage, and governance challenges. She notes that regulators expect completeness, traceability, methodological transparency, and auditability even when patient identifiers are removed. Lamppa adds that not all secondary data sources meet these standards, making provenance and normalization critical for submission readiness.
• Roche reported positive topline results from its Phase II CT388-103 trial evaluating CT-388, an investigational dual GLP-1/GIP receptor agonist for obesity. The once-weekly injectable achieved placebo-adjusted mean weight loss of up to 22.5% at 48 weeks, with no plateau observed and a consistent dose-response relationship. Roche said Phase III trials are expected to begin in the first quarter of 2026.

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