ACT Brief: Organizational Shifts in Trial Design, Amyloid Antibody Evidence Review, and Compounding's Role in Care Continuity

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

• In part one of a new interview, Mark Freitas, managing director and life sciences practice lead at Alvarez & Marsal, explained why the most consequential shift in clinical trial design is organizational rather than methodological. Analysis of 200 FDA complete response letters reveals where decisions systematically go wrong, pointing to structural misalignments rather than individual protocol flaws.
• A Cochrane systematic review pooling 17 trials of amyloid-targeting antibodies concluded the drug class offers little clinically meaningful benefit, drawing sharp criticism from researchers. Critics argue that combining failed therapies with approved treatments obscures individual drug performance, conflates distinct mechanisms of action, and masks modest but potentially meaningful benefits seen in successful agents now in clinical use.
• In a new Q&A from Pharmaceutical Executive, Dr. Nicole Snow, senior clinical pharmacist at Wesley Pharmaceuticals, discussed how compounding addresses care gaps by enabling precise dose adjustments, alternative dosage forms, and allergen avoidance for patients with swallowing, absorption, or intolerance constraints. Compounding also preserves continuity of care during drug shortages or discontinuations, particularly valuable for pediatric, geriatric, and medically complex populations.

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