Is there really an ethical conflict in clinical trials?

Abstract

Statistical concerns and considerations have an impact on the conduct and assessment of meaningful clinical trials, but the ethical principles are of foremost concern to all of us who are involved as physician investigators. Potential participants and their physicians often find clinical trial participation problematic, and the educa- tion of both groups regarding the logic and the ethics of such investigations remains crucial.' Progress in this educational process has occurred during recent years, and the importance of clinical trial participation is being accepted and appreciated more. There is increasing rec- ognition that improvements in therapy depend on the conduct of appropriate prospective clinical trials, and participants in such trials, particularly Phase Ill clinical trials such as those of the National Surgical Adjuvant Breast Project (NSABP), also will receive the optimal treatment of the day. We completely agree with Dr. Mueller's final statement in his commentary that Clin- ical research is essential in our sophisticated statistical society if medicine is to advance, but unethical research is unacceptable.2 Adverse publicity regarding what is perceived to be a major ethical problem in the conduct of trials within the highly respected cooperative group, the NSABP, clearly has been a setback in this extremely important process for improving cancer patient care. Dr. Mueller thoughtfully has addressed this recent problem of fraud on the part of one of the participating investigators. As past