Design and current status of the NSABP breast cancer prevention trial

From its inception the BCPT has been the focus of bitter sustained controversy. In spite of reassessments by numerous advisory groups that have deemed the trial to be scientifically, clinically and ethically sound, its opponents have continued their assaults. That the trial has survived is a tribute to Dr. Fisher's leadership and the dedication of many clinical investigators, who, in spite of the injustice that they have endured, continue to believe in the goals of the NSABP clinical trials. Even greater credit and recognition should be given to the women randomized who have continued their commitment to the study. Their altruism and courage are to be acknowledged. These women undoubtedly understand that the trial affords potential risks, as well as benefits, and that even if the drug is eventually found effective in preventing breast cancer, half of them will have received a placebo in the trial. The ultimate tragedy will be if the study fails to answer definitively the study hypotheses because of what has occurred this past year. We are hopeful that, despite this disruption, the trial will continue to a successful completion. While larger multicenter randomized clinical trials clearly have vulnerabilities and imperfections, we should not lose sight that they are clearly the best mechanism for rigorously testing new therapies in a manner that will provide reliable, generalizable findings.