Ethics in the Design and Conduct of Clinical Trials

The history of medicine reveals the need for clinical research. All too frequently, interventions thought to be safe and effective by clinicians prove to be otherwise. The cur-rent emphasis on “evidence-based medicine ” enunciates the need for carefully obtained data from carefully conducted clinical research; yet the history of medical research in gen-eral, and clinical research in particular, has been an unfortu-nate and littered one in which some physician-scientists have undermined the rights and interests of the participants. While some of the most frequently cited examples of uneth-ical research are clearly egregious, such as the dangerous experimentation on unwilling concentration camp prisoners by Nazi physicians, others are more subtle and involve the misuse of commonly employed, rigorous methods of study design such as randomization and use of placebos. Whil