Emerging International Norms for Clinical Testing: Good Clinical Trial Practice

Abstract

Advances in medicine depend on innovative and bold clinical research. Much of the progress we have seen in the effectiveness and safety of disease treatment, diagnosis, and prevention is the result of intensive research involving human subjects. The pharmaceutical industry has a leading role as a sponsor of clinical research and clinical trials aimed at development of new therapies. There is a consensus that clinical research conducted anywhere in the world should be ethically acceptable as well as scientifically sound. A number of national, regional, interregional, and international ethical documents and norms have been developed during the last five to six years to guide investigators, ethical committees, the pharmaceutical industry, and other sponsors in the ethical conduct of clinical trials. Some of these documents, such as the World Medical Association's Declaration of Helsinki, the World Health Organization's Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products, and the International Ethical Guidelines for Biomedical Research Involving Human Subjects developed by the Council for International Organizations of Medical Sciences (CIOMS), are sets of ethical principles and recommendations, but may become norms if they are included in national regulations and legislation. Others, such as the GCP Guideline of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the EU (European Union) Directive on Clinical Trials, are binding because they have been or will be implemented through national legislation.