ACT Brief: APAC Trial Advantages, Learning From Setbacks, and Sunharbo Stroke Prevention Approval

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

• In part four of a video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, outlines why faster recruitment, local data requirements for registration, and lower costs make APAC attractive for global Phase III programs. His argument centers on those three advantages for sponsors running Phase III trials in the region.
• In a new contributed article, Eyal Shoshani, vice president of clinical affairs at PolyPid, argues that setbacks can strengthen development when teams interrogate the evidence rather than abandon it. He describes a pivotal surgical infection prevention study that missed its primary endpoint, then was redesigned around the high-risk patients most likely to benefit and met its goals. The article concludes that clinical research professionals increasingly need to act as strategic leaders who can navigate scientific uncertainty.
• The FDA approved Bayer’s Sunharbo in combination with antiplatelet therapy to reduce stroke risk in adults after a recent non-cardioembolic ischemic stroke or a high-risk transient ischemic attack. In its Phase III trial, Sunharbo reduced ischemic stroke by 26% compared with antiplatelet therapy alone, with a similar rate of major bleeding to placebo. It is the first approved Factor Xla inhibitor worldwide.

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