s the number of decentralized clinical trials (DCTs) continues to grow, the US FDA, the US Office for Human Research Protections, Harvard’s Multi-Regional Clinical Trials (MRCT) Center, Medable, and other industry stakeholders have collaboratively developed a new toolkit to streamline and accelerate IRB/Ethics Committee review of DCT applications. Medable Chief Science Officer Pam Tenaerts and Harvard MRCT Director Barbara Bierer explore the strategic and practical benefits of this new toolkit with DIA Head of Science and Scientific Strategy Courtney Granville in this DIA Global Annual Meeting 2023 interview.

“While the adoption curve is definitely up, it’s still very nascent. There’s not much experience for IRBs or ethics committees to understand how to best review them without overreaching, making sure that they address all the topics that they need to be addressing, which are not completely different but slightly different than in regular clinical trials,” Tenaerts explains.

“We always worry about security and privacy and quality of the data. But it’s different when everything is, or when many things are, mobile versus in a structured site, a physical location,” says Bierer. “We’ve seen a lot of increase in the adoption of DCTs, particularly since we became reliant on technologies during COVID, and we learned a lot about how different people were using DCT elements.

“In consent, how do you verify identity? How do you make sure you have a signed document that you can track and trace? It’s different than when you’re sitting in front of somebody, and they have a chance to ask their questions. We went through each piece of the journey that a participant may go through on a DCT and asked: What’s different, and what are the issues, both ethical and practical?”