Clinical trials with medical devices: Expected changes in the legal requirements and BASEC
Position paper by Swissmedic and swissethics on decentralized clinical trials (DCTs) with medicinal products
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.
swissethics publishes the updated templates of the protocols for research projects of further use
The further use of data and samples for research purposes accounts for an increasingly growing proportion of all research projects conducted in Switzerland. Questions on Big Data and data sharing, e.g. also in the context of large national projects such as SPHN, are often in the foreground.Read more
In memoriam Professor Dr. med. Peter Meier-Abt
Peter Meier Abt passed away on May 27, 2021. He was a lifelong advocate for medicine in Switzerland and far beyond at universities, at the Swiss Academy of Medical Sciences, and other institutions.Read more
Federal Council breaks off negotiations on the institutional agreement with the EU: Consequences for the clinical research of medical devices in Switzerland
On May 26, the Medical Device Regulation (MDR) at EU level and in Switzerland the ordinance for clinical trials of medical devices (ClinO-MD) came into force. At the same time, Switzerland broke off the negotiations on the framework agreement with the EU.Read more
swissethics publishes a new template of the patient information for the “Re-Consent”
In clinical trials, sometimes fundamental conditions change in the course of the study, for example when new safety data are available or it is clear that the participants are exposed to a (new) risk. In this case, an amendment is submitted to the ethics committee and the participants must be informed accordingly and give their consent in writing (so-called "re-consent").Read more