Clinical trials regulation

Clinical trials regulation protects participants while enabling reliable medical evidence. In Switzerland, human research rules require scientific validity, favourable risk-benefit assessment, informed consent, special protection for vulnerable persons, ethics committee approval and regulatory authorisations where relevant. Trials involving therapeutic products are also subject to medicinal product or medical device oversight and good clinical practice standards. Sponsors and investigators must document protocols, report safety events and ensure data integrity. Comparative differences arise in approval timelines, insurance, transparency, use of data and cross-border multicentre studies.