ACT Brief: eSource Data Integration, Direct-to-Patient Site Performance, and Pragmatic Trial Safety Framework

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

• In a new podcast episode, Jonathan Andrus, co-CEO of CRIO, and Samir Jain, vice president of product management at Medidata, discussed their partnership enabling seamless data flow between site-level eSource and enterprise platforms. The "plug-and-play" integration eliminates manual data entry and reduces operational burden, particularly for smaller or resource-constrained sites, while improving data accuracy across global trial networks.
• Tufts CSDD and Science 37 published findings on direct-to-patient clinical trial sites showing significantly higher enrollment per site, 86% completion rates versus 36% benchmark, and shorter cycle times from first patient to database lock. DTP sites enrolled approximately 20-30% of trial participants with six times higher enrollment than traditional sites, though patient representation gains vary by demographic group depending on trial design and population preferences.
• TransCelerate and FDA released a summary report on selective safety data collection for pragmatic trials, based on a tabletop exercise spanning four therapeutic areas. The work translates risk-based safety surveillance concepts into protocol-level decisions while maintaining patient safety and data integrity in naturalistic settings, building sponsor confidence in adopting pragmatic trial elements.

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