Position Paper by Swissmedic and Swissethics on Decentralized Clinical Trials (DCTs) with Medicinal Products

On 1 November 2021 the Swissmedic issued the updated guidance on DCTs.

The development of novel technologies and digitalization in the field of therapeutic products offers new opportunities. Through the use of these technologies in clinical trials, it is possible that study visits do not always have to be carried out in the hospital, but can also take place at home. In this context, innovative technologies allow health-related data to be digitally recorded and transmitted via devices worn on the body. These special features and other aspects play an essential role in so-called decentralized clinical trials (DCTs).

This development poses new challenges for all those involved. In a position paper, Swissmedic and Swissethics have summarized the main current challenges of DCTs with medicinal products and show under which conditions such clinical trials could be conducted in Switzerland. The paper is addressed to researchers and sponsors as well as all those interested in clinical research.

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