ACT Brief: ESG as Commercial Selection Factor, Real-Time Monitoring Scale Readiness, and FDA Cancer Trial Eligibility Expansion

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

• In the pilot episode of a new podcast series, Beyond Compliance, Otis Johnson, founder and principal consultant at Vantix Operations, spoke with Paulo Limgenco, VP of business operations and ESG strategy lead at YPrime, about how sustainability is moving from a reporting exercise into a commercial procurement factor. While a strong ESG position rarely wins business outright, it increasingly disqualifies vendors or opens doors that would otherwise stay closed, making it a meaningful consideration alongside product quality in sponsor decision-making.
• In part three of his interview, Raviv Pryluk, CEO and co-founder of PhaseV, explained why the FDA's real-time clinical trial pilot was promising but not yet scale ready. The enabling technology is LLM-driven automation of data standardization to ADAM and STDM formats, a prerequisite for real-time monitoring to work broadly; scaling the model will require an ecosystem approach involving regulators, sponsors, CROs, and vendors in transparent shared learning rather than siloed company efforts.
• The FDA's Oncology Center of Excellence finalized three guidances designed to expand cancer trial participation by targeting unnecessarily restrictive eligibility criteria around performance status, washout periods, and laboratory values. Despite over 70% of cancer patients reporting willingness to participate in trials, fewer than 5% are actually enrolled, a gap the agency attributes partly to criteria that exclude patients without clear scientific or safety rationale.

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