Content - Guidelines

Rules and regulations

A multi-stage approval process guarantees the best-possible safety for study participants. Every medical study has to go through a strict step-by-step plan, especially studies on new medicines. The rules and regulations stipulate amongst other things the conditions under which the studies must be carried out and the requirements that a study protocol has to meet.

 

International rules

Clinical research is subject to the European Convention on Human Rights and Biomedicine (Biomedicine Convention), which lays down binding requirements for medical research, and adheres to internationally defined rules, such as quality standards for clinical studies (GCP: Good Clinical Practice), and the Declaration of the World Medical Association on ethical principles for medical research in humans (Declaration of Helsinki).

 

National rules

Clinical research is subject to the legal and ethical principles of the Swiss Academy of Medical Sciences (SAMS), the Swiss Agency for Therapeutic Products Swissmedic and Swiss laws. Clinical researchers must comply with the Ordinance on Clinical Tests with Therapeutic Products (ClinO). Studies for the evaluation of new medicines are also subject to the Swiss Therapeutic Products Act. The collection of samples such as tissue, blood or cells and also genetic tests must be in keeping with the biobank guidelines of the SAMS. Data protection laws are also applicable. In addition, cantonal regulations must also be followed.

 

Ethics committees

The ethics committees in Switzerland operate on a cantonal basis and to some extent are also regional linked. They only approve studies if these are ethically acceptable, offer a realistic hope of success and preserve the rights of the persons studied.

 

Swissmedic

Safety measures are not only guaranteed by the doctors concerned, but also promoted and checked by the authorities. Swissmedic, which is part of the Federal Department of Home Affairs (FDHA), is responsible for the quality, safety and efficacy of medicinal products and medical devices and registers, approves and monitors every single clinical study.

 

Registration of clinical studies

Clinical studies should be publicly registered, and are accessible through institutions such as www.clinicaltrials.gov. Study doctors and the public thus have an insight into what clinical studies are being carried out in a given indication and at a given centre.