The Impact Of ADAPTABLE: The Industry's First And Largest Fully Decentralized Clinical Megatrial

For more than half a century, millions of Americans living with heart disease have relied on a daily dose of aspirin to reduce the risk of heart attack or stroke. Despite its widespread use, uncertainty remained around the optimal dosage—most commonly 81 mg or 325 mg—to balance efficacy with safety. The ADAPTABLE study was designed to address this question at unprecedented scale, and Medidata was selected to provide eClinical solution support based on its deep industry expertise and comprehensive technology capabilities. The study was conducted between 2016 and 2021.

A traditional clinical trial of this size and scope would have cost more than $100 million. By adopting a decentralized model, ADAPTABLE reduced total costs to less than $20 million, while enabling rapid enrollment and execution. This approach established ADAPTABLE as the industry’s first—and largest—fully decentralized clinical megatrial.

The study team leveraged innovative decentralized clinical trial (DCT) methodologies to enroll a large, geographically diverse patient population. The protocol was intentionally designed to engage patients who might not otherwise participate due to distance, mobility constraints, or reluctance to travel to centralized trial sites. To support this model, robust clinical technology and professional services were deployed across patient, site, and sponsor workflows. While decentralized trial components were still emerging when ADAPTABLE launched in 2016, their successful application in this study helped accelerate broader industry adoption and set a new benchmark for clinical trial design.