ACT Brief: Wearable Data in Clinical Care, Generalized Pairwise Comparisons, and Vaccine Policy Litigation

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 video interview with Mohammed Saeed, MD, PhD, chief medical officer of Solera Health, he discussed the significance of wearable data in routine clinical practice. Wearables provide clinicians insight into patient health outside the clinic setting, revealing how patients manage real-world stresses and identifying those needing earlier intervention — a unique perspective unavailable through traditional office visits alone.
• In part five of his video interview, Marc Buyse, founder and CEO of IDDI, highlighted generalized pairwise comparisons as an emerging method with potential to transform trial design and analysis. Rather than analyzing a single primary outcome, this approach — including the win ratio used in cardiovascular disease — incorporates multiple hierarchical outcomes simultaneously, increasing statistical power and aligning analysis with what patients actually care about across multiple clinical events.
• A federal judge ruled that HHS Secretary Kennedy improperly replaced the CDC's vaccine advisory committee, placing a hold on decisions made by the current committee including revised vaccine schedules and COVID-19 and Hepatitis B vaccine recommendations. The ruling agreed that the secretary's actions violated the Federal Advisory Committee Act, with plaintiffs including the American Academy of Pediatrics and other medical professional organizations arguing that decisions must be grounded in science rather than policy preferences.

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