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The Clinical Trials Industry’s Weekly News Update

EC moves to bolster decentralized trials in EU

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The European Commission (EC) has moved to support remote studies with recommendations that encourage firms to consider decentralized trials.

The recommendations are designed to “facilitate the conduct of decentralized clinical trials (DCTs) while safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected,” according to the EC.

The Commission cited faster recruitment, the potential for greater ethnic diversity and reduced withdrawal rates among the potential benefits, pointing out that allowing people to take part in drug research without having to travel is a major advantage.

The EC also acknowledged the role technology plays in remote trials, writing “decentralization is enabled by the advancement of digital tools, telemedicine, and more mobile and local healthcare. It includes aspects such as home health visits, remote monitoring and diagnostics, direct-to-patient shipment of study drugs and electronic informed consent.”

In addition to some general considerations, the EC recommends that sponsors that opt for decentralized trials – or those that use remote elements – ensure staff working on the study fully understand their patient care responsibilities.

“When parts of the clinical trial are conducted off-site, and when additional service providers such as home nurses or providers of technology become involved, it is essential that the specific roles and responsibilities of the sponsor, investigator, and any additional parties are clearly defined and understood prior to the start of the trial.”

Accelerating trials

The recommendations were developed by the EC, the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) as part of a wider joint initiative to Accelerate Clinical Trials in the European Union (ACT EU).

The initiative was launched in January 2022 and aims to further develop the EU as a focal point for clinical research, to promote the development of high-quality, safe, and effective medicines and to better integrate clinical research in the European health system.

Unsplash/ShubhamDhage

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