Regulatory Opportunities For Decentralized Clinical Trials: Insights From The SHASTA Project

By Anna Yang, Genentech, a member of the Roche Group

The increasing cost and complexity of traditional brick-and-mortar clinical trials present significant hurdles for the pharmaceutical industry. Decentralized clinical trials (DCTs) offer a compelling path forward, promising faster enrollment, improved participant retention, and greater diversity in trial populations. But how do these novel approaches truly measure up, and what regulatory adaptations are needed to fully realize their potential?

Project SHASTA, a pioneering initiative, sought to answer these critical questions by evaluating the real-world impact of DCT elements. Discover the key regulatory opportunities identified by the SHASTA project that could shape the future of clinical research. Read the full article to learn more.