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Alira Health’s Take on the EMA DCT Guidance

Last week the European Medicines Agency (EMA) published their “Recommendation Paper on Decentralised Elements in Clinical Trials”, providing guidance on new virtual methods in clinical trials that are rapidly gaining in popularity. Decentralized clinical trials involve the use of remote or virtual technologies to conduct clinical research and have the potential to increase access to clinical trials for both patients and investigators by reducing cost, increasing convenience, and reaching a more diverse pool of participants.

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Published on:

December 19, 2022

Written by:

Jared Adams, MD, PhD

Above all, the Recommendation Paper advises that the patient perspective should guide decentralized protocol development and the benefit-risk calculation of decentralized elements such that 'the rights, safety, dignity and well-being of the trial participants should be protected and prevail over all other interests.'"

Jared Adams, MD, PhD Senior Vice President, Product Management and Design

Paper Summary – The Patient Perspective is Paramount

The Recommendation Paper provides guidance on the design and conduct of decentralized clinical trials. It covers a range of topics, including the use of electronic informed consent, remote monitoring and data collection, stakeholder responsibilities and risk mitigation strategies. Concerns that must be addressed at the protocol stage include questions of generalizability, validity, and handling of missing data. Utilizing multiple systems and parties adds complexity and requires additional oversight. Overall, the recommendation paper emphasizes the importance of ensuring the quality, integrity, and reliability of decentralized clinical trials and provides guidance on how to achieve these goals through the careful consideration of appropriate technologies and protocols.

Above all, the Recommendation Paper advises that the patient perspective should guide decentralized protocol development and the benefit-risk calculation of decentralized elements such that “the rights, safety, dignity and well-being of the trial participants should be protected and prevail over all other interests.”

Read the Recommendation Paper