Ethical aspects of drug development

Abstract

In order for an active substance to get registration as a drug, preclinical development should be followed by three phases of clinical trials. Clinical phase I recruits healthy volunteers or patients in certain conditions, whereas later phases recruit well defined patient populations. All clinical studies have to be authorized by the competent authority and evaluated by an independent ethics committee. No clinical trial can be initiated in the absence of a supportive opinion from the responsible ethics committee of the country where the study will be conducted. The ‘ethics committee’ is an independent body in a EU member state, consisting of healthcare professionals and non-medical members, whose responsibility it is to protect the rights, safety and wellbeing of human subjects involved in a trial. Each and every protocol should be individually evaluated. All that evaluation is based on the Good Clinical Practice (GCP) and on the World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects. The Declaration is reduced to practical approach by EU regulation and national laws. The Hungarian experience of the Ethics Committee for Clinical Pharmacology, Medical Research Council, is highlighted.