Ethical problems in clinical research: the need for empirical studies of the clinical trials process.

Society's demand for progress in medicine is expressed in the form of large sums of money poured into medical research by national governments and voluntary agencies. It is widely accepted within the medical profession that society has a right to expect continuing progress in medical practice and it has been argued that the doctor must therefore sometimes weigh society's interests against those of his individual patient. This essay discusses the origin of the concept of the societal obligation of the physician and the difficult position of the clinician-scientist who attempts to meet society's demands for progress while maintaining his traditional loyalty to the individual patient. Empirical studies which describe the impact of the clinical trials process on the practice of medicine are discussed and it is shown that the large scale clinical trials of today may influence aspects of medical practice far removed from the immediate problems which they are designed to study. It is concluded that further research is needed to study the process of clinical experimentation and its societal implications and that the debate must extend beyond the medical profession to involve the general public.