Case Study: Duke University Medical Center achieves a cost-effective, patient-centric, fully decentralized clinical megatrial with Medidata Solutions

The Impact of ADAPTABLE The Industry’s First and Largest Fully Decentralized Clinical Megatrial

Medidata partnered with the Duke Clinical Research Institute on ADAPTABLE, a Patient-Centered Outcomes Research Institute–funded study designed to determine whether 81 mg or 325 mg of aspirin is optimal for heart disease patients. The challenge was running a megatrial that would be representative, cost-effective, and accessible to geographically dispersed or homebound patients while maintaining regulatory compliance and data quality.

Medidata provided a suite of decentralized trial technologies and services—myMedidata/Mytrus portal, EHR‑based “golden ticket” recruitment, remote eConsent and eSource, dosing and safety tracking, reminders and call‑center support—enabling fully virtual enrollment and follow‑up. The approach engaged tens of thousands via access codes, enrolled 15,000+ participants across ~40 centers, cut projected costs from over $100M to under $20M (~5x savings), improved patient engagement and diversity, supported the finding that low‑dose (81 mg) aspirin is preferable for most patients, and earned top industry recognition.

Duke University Medical Center

Schuyler Jones

Associate Professor of Medicine