Switzerland\nhas a long tradition of clinical research and the medical care provided at its\nuniversity hospitals is outstanding. Yet the number of clinical trials\nperformed in Switzerland has been declining for years, due to low patient\nnumbers, decentralised and in some instances time-consuming processes involving\nthe Ethics Committees, and slow recruitment combined with growing international\ncompetition. High costs and the multilingual nature of the country are further\ndisadvantages for organisations working on networked research projects. They\ninhibit investment in the Swiss research landscape. Against this background,\nthe framework conditions for research take on a central role.<\/p>\n\n\n\n
Research\nin humans is indispensable in order to study the causes of diseases and develop\nnew methods for diagnosis, therapy and prevention. New treatment methods, such\nas new medicines or surgical techniques, can only be used for the benefit of\npatients if they have first been tested for efficacy, tolerability and safety.<\/p>\n\n\n\n
Before\na medicinal product is authorised, its efficacy and safety must be demonstrated\nin clinical trials. Globally recognised legal principles exist to protect the\ndignity of humans in research and to safeguard the rights of the individual.\nThe Swiss legislation governing clinical research is based largely on these\nstandards. At the same time, the freedom of research is of central importance\nto progress in medicine. New findings lead to better diagnosis and therapeutic\noutcomes and can help to prevent diseases.<\/p>\n\n\n\n
The\nHuman Research Act uniformly and comprehensively regulates research involving\nhumans in Switzerland. The Constitution regulates fundamental aspects of\ninformation and consent to a research project and the risks and inconveniences\nfor participants. Particular care is taken to protect individuals not capable\nof judgement, such as children or people with disabilities. Finally, the\nConstitution requires every research project to be reviewed to ensure that\nthose participating in it are protected. The Federal Act on Research involving\nHuman Beings (Human Research Act) specifies the article of the Constitution in\nmore detail. It is designed to protect the dignity, identity and health of\nhumans in research. It is also intended to create favourable framework\nconditions for research involving humans, help to ensure the quality of human\nresearch and ensure the transparency of human research.<\/p>\n\n\n\n
In\naddition to the Human Research Act, other legislation governs individual\naspects of research involving humans, e.g. the Therapeutic Products Act (TPA),\nwhich regulates clinical trials with medicinal products and medical devices,\nthe Transplantation Act, and the Stem Cell Research Act (StRA). The Swiss\nAcademy of Medical Sciences (SAMS) has additionally drawn up medical and\nethical guidelines for research involving humans and for biobanks. Finally, the\nlegislation is Switzerland is guided by the internationally recognised\nguidelines for Good Clinical Practice (GCP) based on the Declaration of Helsinki\ndeveloped by the World Medical Association. The Swiss Pharma Cooperation Code\nis also based on these principles.<\/p>\n","protected":false},"excerpt":{"rendered":"
Switzerland has a long tradition of clinical research and the medical care provided at its university hospitals is outstanding. Yet the number of clinical trials performed in Switzerland has been declining for years, due to low patient numbers, decentralised and in some instances time-consuming processes involving the Ethics Committees, and slow recruitment combined with growing […]<\/p>\n","protected":false},"author":1,"featured_media":14776,"parent":4214,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"page-templates\/unterthema.php","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-4040","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"\n