International Guiding Principles for Ethical Conduct of Clinical Trials: Implications for Generics

Abstract

As a result of intensive international debate, consultations and collaboration, a number of ethical documents and guidelines have been developed by the World Medical Association (Declaration of Helsinki), Council for International Organizations of Medical Sciences (CIOMS), World Health Organization (WHO Guidelines for Good Clinical Practice) and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Good Clinical Practice Guideline). From May 2004, all 25 EU member states will be required to implement the legally binding EU Directive on clinical trials. In general, the ethical principles regarding clinical research are consistent in these documents; however, some have been developed more for regulatory purposes whereas others are recommendations and guiding principles. Some documents focus particularly on ethical guidance for clinical trials conducted in developing countries. Taken literally, the Declaration of Helsinki and the CIOMS Guidelines do not indisputably support the ethics of pharmacokinetic studies in which the aim is solely to demonstrate bioequivalence for commercial purposes in non-therapeutic trials. This paper reviews the evolution of ethical guidance in clinical research and discusses how the current international ethical documents advise on drug development research in the generic pharmaceuticals industry.