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.
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.”
Alira Health’s Health Storylines – Putting Patients at the Center
At Alira Health, we offer a single patient driven “product lifecycle research platform” in Health Storylines that follows the product from early phase clinical trials to post-marketing and the patient along the entire patient journey until there is patient impact. As a leader in decentralized clinical trials, Alira Health can help stakeholders carefully evaluate the feasibility and suitability of decentralized approaches for a specific trial, and to ensure that appropriate safeguards are in place to mitigate any potential risks.