This book describes how clinical trials of pharmaceuticals are conducted and regulated. Clinical trials on human volunteers are necessary to test the safety and efficacy of pharmaceuticals (drugs) before the latter can be authorized and released on the market. The
entire clinical development of a pharmaceutical lasts several years and involves thousands of volunteers. From a financial perspective, this development is both expensive and risky. Clinical trials are situated at the intersection of science, law and economics. This book weaves together these various aspects. It is divided in three main sections, the first focuses on historical and economic issues, the second on scientific concepts, the third on the key legal provisions. Laws taken into consideration include those of Switzerland, the United States and the European Union. Although the emphasis is on Switzerland and its recently (2002) enacted legislation, comparisons are systematically made with E.U. and U.S. regulations and case law.Whenever reasonable, these texts are examined critically.
This book is not exclusively aimed at the legal profession. Although it makes extensive reference to laws, regulations, guidelines, and case law, it is accessible to all persons curious to know more about clinical trials. Physicians participating as investigators in clinical trials and regulatory departments of pharmaceutical companies should find it particularly helpful.