An Overview Of Ethical Issues In Drug Trials

Abstract

Drug trials date back to antiquity and are necessary aspects of scientific advancement. Many drug trials have been discredited after data publication or even prevented from reaching completion either because of ethical or protocol violation. There is therefore a need to review current issues on ethics in drug trials in an attempt to encourage vigorous research activities on new drugs. A review of literature regarding ethics in drug trials was undertaken with the aid of published materials. The history and phases of drug trials was
surveyed with emphasis on ethical considerations. Ethics in drug trials is grounded on he concepts of GCP which has two basic principles viz: protection of the rights, safety and welfare of trial subjects and the generation of credible data. Although advancement in medical science is desirable the welfare of the subject must prevail over the interest of science/society.

Keywords: Placebo, ethics clinical trial, Good Clinical Practice, Standard Operating Procedure