ACT Brief: AI Governance Lag, Site Payment Experience, and Schizophrenia Relapse Prevention

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

• In part five of his interview, Mark Freitas, managing director and life sciences practice lead at Alvarez & Marsal, identified governance inertia and review cycle lag as underappreciated risks when AI speeds up protocol development faster than organizations can act on the insights it generates. Structural misalignment between technology capability and decision-making capacity creates bottlenecks that offset efficiency gains.
• In a new contributed article, payment experience—including timeliness, transparency, and consistency—is emerging as a key operational factor influencing site retention and trial outcomes. Over 70% of sites experience financial stress while waiting for reimbursement, and inconsistent payment structures across studies force sites to navigate unclear terms repeatedly. Sponsors prioritizing transparent, responsive payment processes are gaining competitive advantage in a constrained site environment.
• Johnson & Johnson received FDA approval for Caplyta for relapse prevention in schizophrenia based on Phase III data showing 63% reduction in relapse risk and 84% remaining relapse-free at six months. The label expansion reflects industry efforts to differentiate antipsychotics on long-term outcomes including relapse prevention and tolerability alongside efficacy.

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