ACT Brief: eCOA Costs and Paper Persistence, Early Phase Statistical Foundations, and DEI Progress in Trials

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

• In a new column, EAB member Scottie Kern of the eCOA Consortium explored why paper-based clinical outcome assessments remain in use despite ALCOA++ advantages with eCOA. Cost visibility creates asymmetry—eCOA fees are explicit while paper's hidden costs in monitoring, SDV, transcription, and regulatory risk remain diffuse. Small studies, rapid country activation, and regional infrastructure gaps create genuine exceptions where paper economics are hard to justify, though panelists agreed eCOA is preferable in most circumstances.
• In the fifth and final part of her video interview, Sam Hinsley of Phastar explained why early phase statistical decisions form the foundation of entire development pathways and what is at stake when those critical choices are made on limited data.
• In our latest FAQ article, despite political headwinds, life sciences leaders are maintaining DEI commitments but translating that into representative enrollment requires structural changes to protocol design, site selection, and community engagement that most of the industry has yet to fully implement.

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