The breast cancer research scandal: addressing the issues.

The three claims put forward by Dr. Roger Poisson to rationalize his enrollment of ineligible subjects in clinical trials do not justify research fraud. None the less, certain lessons for the conduct of clinical research can be learned from the affair: experimental therapies should be made available to technically ineligible subjects when no effective therapy exists for their disease; further research must investigate the possible benefits of clinical-trial participation; broadly based, pragmatic trials must be regarded as the ideal model; and each eligibility criterion in a clinical-trial protocol should be justified.