ACT Brief: Diversity Embedded as Standard Practice, Early Phase Statistician Collaboration, and First HDV Treatment Approved

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

• In a new Q&A, Adrelia Allen discussed how Merck embeds diversity into clinical trial execution as standard practice rather than initiative, with accountability measured through diversity action plan performance and long-term community presence. Allen emphasized site selection intentionality, protocol design that addresses social determinants of health, and partnerships that extend well beyond recruitment—including the Let's Talk Trials campaign, which has generated over 20 million impressions in under a year.
• In part four of her video interview, Sam Hinsley discussed the Early Phase ESIG, a new special interest group bringing together statisticians from academia and industry to share knowledge and raise standards in early phase research design and execution.
• FDA granted accelerated approval to Gilead's Hepcludex for chronic hepatitis delta virus, the first approved therapy for this aggressive liver disease that occurs only with hepatitis B infection. Approval was based on MYR301 showing superior 48-week combined virologic and biochemical responses, with confirmatory data required to maintain approval.

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