MRCT Center and Medable Collaborate to Launch Comprehensive Toolkit for IRB/EC Review in Decentralized Clinical Trials

Wednesday, June 21, 2023

Medable Inc. and the MRCT Center (Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard) have collaborated to launch a comprehensive toolkit for Institutional Review Boards (IRBs) and Ethics Committees (ECs) in the context of decentralized clinical trials (DCTs). This toolkit, the first of its kind, aims to standardize the ethics review process for DCTs and provide a roadmap for conducting these trials ethically.

The DCT IRB/EC Review Toolkit offers a common framework, tools, and best practices to facilitate uniform ethical review and approval. By establishing standardization, the toolkit aims to simplify and expedite the IRB/EC process, contributing to more efficient and patient-centered research execution.

The development of this toolkit is a response to the challenges posed by DCTs, such as varying technologies, risks, benefits, and ethical considerations. The involvement of stakeholders, including Advarra, MRCT Center, Medable, the FDA, the OHRP, ethics committees, research sites, patients, and patient advocates, has ensured comprehensive insights and guidance for the ethical conduct of DCTs.

The DCT IRB/EC Review Toolkit consists of 13 guides organized around three themes: people, data collection, and data oversight. It covers essential elements of decentralized trials, such as electronic consent (eConsent), electronic clinical/patient-reported outcomes assessment (eCOA/ePRO), wearable devices, and remote telehealth visits.

By harmonizing the ethical review, approval, and conduct of DCTs, the toolkit aims to remove barriers to adoption and facilitate the realization of the full potential of decentralized clinical trials.



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