ETHICS AND STATISTICS IN CLINICAL RESEARCH - TOWARDS A MORE COMPREHENSIVE EXAMINATION

The ethical analysis of research with human subjects has been greatly developed over the last 20 years, with input from researchers and statisticians as well as philosophers. That all such research must satisfy ethical norms, what those ethical norms are, and how these norms should be applied to clinical research, are all now matters of common agreement. Certain critical questions, such as informed consent to research and the risk-benefit ratio associated with trial participation, have been carefully parsed in the literature. However, it remains the case that major aspects of clinical trials are rarely subjected to ethical scrutiny, particularly those of most concern to stastisticians. By specific reference to two such questions - the size of the clinical study, and the patient population eligible for the trial - and their numerous ethical as well as scientific implications, we argue for an approach to clinical trial ethics that comprehensively subjects each aspect of a trial to ethical analysis.