Swiss Medicines Regulator Issues Position Paper on Decentralised Clinical Trials
- 17/02/2025
- News
On 10 February 2025, the Swiss medicines agency, Swissmedic, and the Swiss Association of Research Ethics Committees, Swissethics, issued an updated version of their position paper on decentralised clinical trials with medicinal products (DCTs) (see, attached copy; the Position Paper). DCTs are clinical trials that rely on procedures conducted outside the traditional clinical trial site. In practice this often means the trial subject’s home.
While focused on Switzerland, the Position Paper provides an interesting overview of the key regulatory and ethical considerations for conducting DCTs, with references to internationally applicable guidance such as the Good Clinical Practice Guideline of the International Council for Harmonisation. Furthermore, the Position Paper takes account of recommendations issued by the European Commission and European health bodies and, more recently, the US Food and Drugs Administration. Consequently, it serves as a useful reference document to clinical trial sponsors and other stakeholders involved in DCTs, irrespective of whether these trials are conducted in Switzerland.
Topics discussed in the Position Paper include:
- recruitment of potential trial subjects through digital channels;
- performance of trial-related interventions outside the trial site;
- trial oversight and responsibilities;
- dispensing and administering the investigational medicinal product outside the trial site;
- data capture outside the trial site using mobile devices;
- whether the mobile devices used qualify as medical devices and the consequences resulting therefrom;
- remote source data verification; and
- organisational aspects for regulatory GCP inspections.
The Position Paper is accompanied by an annotated table which compares the feasibility of various DCT elements in the individual EU Member States and Switzerland (see, appendices 1-3). The table is identical to that included in the European recommendation paper on decentralised elements in clinical trials of December 2022, but was supplemented by references to relevant provisions of Swiss law. The table shows that there remain many regulatory hurdles to conducting DCTs due to diverging national rules and regulations across the EU and Switzerland.
