In today's ACT Brief, we examine practical guidance for clinical operations teams beginning AI adoption, how hierarchical endpoints better reflect treatment benefit, and why early-stage program failures signal smarter pipeline management.
News|Podcasts|May 11, 2026
ACT Brief: eSource Data Integration, Direct-to-Patient Site Performance, and Pragmatic Trial Safety Framework
Author(s)Andy Studna, Senior Editor
In today's ACT Brief, we examine CRIO and Medidata's partnership on seamless clinical trial data flow, Tufts CSDD findings on direct-to-patient site enrollment and diversity outcomes, and TransCelerate's work with FDA on selective safety data collection for pragmatic trials.
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.
Related to this article
In today's ACT Brief, we examine how AI enables sponsors to pressure-test protocols before enrollment, HHS's multi-initiative effort to accelerate trial design and execution, and FDA approval expanding heart disease therapy to adolescents.
In today's ACT Brief, we examine AI's role as trial design advisor with human leadership, how to govern autonomous agents in regulated operations, and real-world outcomes from switching to oral weight-loss therapy.
In today's ACT Brief, we examine how data drives honest enrollment assumptions, why RWE infrastructure lags ambition, and the disconnect between FDA rulemaking and enforcement on compounded therapies.
In today's ACT Brief, we examine what AI simulations surface in trial design, how RBQM delivers measurable financial returns, and three new FDA-approved treatments across hair loss, movement disorder, and bone disease.
In today's ACT Brief, we examine how AI is surfacing endpoint options beyond traditional design thinking, why sponsor oversight of outsourced work often fails on inspection despite being robust in practice, and a new combination drug for advanced kidney cancer.
In today's ACT Brief, we examine what patient-site relationships need beyond easier technology, how to build defensible rare disease evidence from scratch, and how real-world data and AI improve enrollment screening accuracy.
In today's ACT Brief, we examine why defensible trial data depends on traceability and platform ownership, what CGT site readiness requires as therapy moves to community care, and why data harmonization is AI's primary bottleneck.
Trending on Applied Clinical Trials Online
1
The Control Plane for Agentic Clinical Operations: Governing Autonomous Digital Actors in Regulated Trials
2
Hierarchical Endpoints in Cardiology: How Much Treatment Benefit, and From Where
3
HHS Launches SURPASS Program and Three Complementary Initiatives to Transform Clinical Trial Design and Infrastructure
4
What ClinOps Professionals Just Starting With AI Should Keep Top of Mind
5