Medable Inc., a technology provider for patient-centric clinical trials, and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) announced a comprehensive toolkit for Institutional Review Boards (IRBs)/Ethics Committees (ECs) to standardize decentralized clinical trial (DCT) ethics review.

The first-of-its-kind toolkit provides a common framework, tools, and best practices for uniform ethical review and approval and provides a roadmap for the ethical conduct of DCTs. Ultimately, such standardization will simplify, streamline, and speed the IRB/EC process – a key step towards more efficient, patient-centered research execution.

“The new DCT IRB/EC Review Toolkit will ease ethics reviews of decentralized trials by establishing commonality and removing some of the guesswork that has made DCT reviews cumbersome,” said Barbara Bierer, professor of medicine at Harvard Medical School and Faculty Director of the MRCT Center. “The guidelines also clarify what information sponsors and investigators should provide to IRBs on the front end to avoid unnecessary delays.”

The National Institutes of Health (NIH) and other industry groups have repeatedly identified reducing IRB turnaround time as “essential” as delays prevent treatments from getting to patients and slow the improvement of public health outcomes. As DCTs offer potentially faster clinical study execution, disjointed and inconsistent ethics reviews could unintentionally slow the process.

A task force consisting of MRCT Center, Medable, Food and Drug Administration (FDA), Office for Human Research Protection (OHRP), ethics committees, sites, patients, and patient advocates collaborated for more than 18 months to create the new DCT IRB/EC Toolkit. It encompasses 13 guides (organized around three themes of people, data collection, and data oversight) – addressing each common element of a decentralized trial. These range from electronic consent (eConsent), electronic clinical/patient-reported outcomes assessment (eCOA/ePRO), wearable devices, remote telehealth visits, and more.

“Decentralized trials hold tremendous promise but to realize their full potential, we must systematically review every step of the startup process to ensure we are uniformly implementing a DCT startup framework,” said Pamela Tenaerts, chief scientific officer at Medable. “Together, we are working to remove potential hurdles to DCT adoption by harmonizing the ethical review, approval, and conduct of DCTs.”

A 2022 financial modeling of DCTs using industry benchmark and Medable data and conducted by the Tufts Center for the Study of Drug Development shows that, on average, decentralized trials can achieve net financial benefits ranging from five to 13 times for Phase II and Phase III trials, due to reduced trial timelines and other factors.