Switzerland – Update of the position paper of Swissmedic and swissethics on decentralised clinical trials (DCTs) of medicinal products
The position paper has been comprehensively amended and updated (new version 3.1). New features include a comparison of Switzerland with European member states in terms of the feasibility of various DCT elements.
This position paper reflects the current state of thinking of swissethics and Swissmedic on decentralised clinical trials (DCTs) with medicinal products in Switzerland interpreting their respective areas of responsibility. The aim is to encourage and invite stakeholders to intensify the dialogue on this innovative way in conducting clinical trials and to find relevant information on the interpretation of the current legal situation in Switzerland. This paper describes a broad variety of topics starting from the recruitment, trail conduct, sponsor- and investigator responsibilities and how oversight should be ensured in decentralised clinical trials. Guidance is also provided on content requirements for drafting the trial protocol, conduct of monitoring visits and task delegation. As this type of clinical trial is relatively new, changes to existing laws and regulations may be required over time and will be included in this guidance on an ongoing basis.
More information on the Swissmedic Website.
OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (26 mars 2025). Switzerland – Update of the position paper of Swissmedic and swissethics on decentralised clinical trials (DCTs) of medicinal products. ELSIBI. Consulté le 5 mars 2026 à l’adresse https://doi.org/10.58079/13knk





