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.

Publications
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.”

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.

Related news

News May 22, 2023
Alira Health Joins France Biotech as an Expert Partner
We are pleased to announce that Alira Health has joined France Biotech, an independent association that brings together healthcare innovation entrepreneurs and their expert partners.
Biotech Clinical Trials France Patient Engagement
Multimedia May 17, 2023
Webinar: How to Increase Patient Engagement in Your Clinical Trials
Engaging with patients, including their caregivers and advocates, is crucial during the planning and execution of clinical trials.
Clinical Trials Patient Engagement
Events April 28, 2023
EWMA 2023
We are pleased to announce that we will join as delegates the 33rd Conference of the EWMA. This year’s theme is “Wound Care - from art to science”, and as always, the conference(...)
Clinical Trials Product Development Wound Healing
News March 27, 2023
Renee Willmon and MG Registry featured in new Rare Disease Article Series
In the article, “Alira Health and the MGFA Partner to Develop a Myasthenia Gravis Registry,” Renee shares how her professional journey has led her to her current involvement in(...)
Clinical Trials Digital Health Patient Advocacy Rare Disease
Blog March 17, 2023
Diversity in Clinical Trials: A Blog Series
How can you successfully engage with patients from diverse populations? To gain the latest insights on the impact, challenges, and strategies, we are pleased to bring you a new series(...)
Clinical Trials Patient Advocacy Patient Engagement
Blog March 16, 2023
How Can Clinical Trials be More Inclusive?
Working with patients and patient leaders early and often can help life science companies to advance the mission of diversifying clinical trials and ultimately, bringing products to(...)
Clinical Trials Patient Advocacy Patient Engagement
Blog March 9, 2023
Challenges to Creating Diversity in Clinical Trials
Now that the FDA has a mandate requiring trial sponsors to include a diversity action plan in their clinical trials, it’s vital that companies comply. What challenges do pharmaceutical(...)
Clinical Trials Patient Advocacy Patient Engagement
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.