ACT Brief: Life Sciences Hold the Line on DEI, Startup Timelines Stretch Further, and Regulators Align on AI Governance

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

• A new Applied Clinical Trials contributed article from EAB member Becky Johnson reports that corporate DEI efforts in life sciences remain largely intact despite intensifying political and legal scrutiny. Analysis of 2025 shareholder meetings shows all anti-DEI proposals were rejected, with boards and executives increasingly reframing inclusion as a driver of innovation, performance, and representative clinical research rather than a standalone initiative.
• In part 4 of a video interview with Applied Clinical Trials, Brian Mallon of ICON says site activation timelines are lengthening due to rising protocol complexity, tighter eligibility criteria, and increased site burden. He notes that earlier, more flexible engagement during feasibility and site identification can help preserve startup momentum. Mallon adds that operating model decisions and clear communication play a critical role in improving activation performance.
• FDA and EMA have jointly released ten guiding principles for the ethical and safe use of AI across the drug development lifecycle. The framework emphasizes human-centric design, risk-based validation, strong data governance, and lifecycle quality management. Regulators say the alignment is intended to support innovation while ensuring AI-generated evidence meets regulatory and patient safety expectations.

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