ACT Brief: AI-Enabled COA Migration, Expanding Trial Footprints into Routine Care, and New FDA Approval in Myasthenia Gravis

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

• New research presented at ISPOR shows how AI-assisted migration of translated COAs into eCOA systems can markedly reduce human-introduced errors, shorten review cycles, and accelerate study startup while preserving human linguistic oversight, reinforcing how AI can help sponsors support broader global participation without compromising cultural or clinical accuracy.
• In the third segment of our McKinsey interview series, Gaurav Agrawal outlines why the industry must shift its trial footprint beyond academic medical centers and into the community settings where most patients actually receive care, emphasizing that this evolution will require simpler protocols, better use of data to identify trial-naive sites, and more intentional support to bring routine-care organizations into clinical research.
• And the FDA has approved Amgen’s Uplizna for adults with antibody-positive generalized myasthenia gravis, adding a twice-yearly CD19-targeted therapy supported by Phase III data showing significant improvements in MG-ADL and QMG scores and offering clinicians a new mechanistic option for managing this rare autoimmune condition.

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