Clinical drug trials

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 usually 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 focused 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 primary focus 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, laws and court decisions are examined critically.