The Ethics of Early Stopping Rules: Who Is Protecting Whom?
Stephen A. Cannistra Program in Gynecologic Medical Oncology, Beth Israel Deaconess Medical Center, Boston, MA Well-conducted clinical investigation, in concert with basic laboratory research, is the cornerstone for progress in medicine. Without it, we are forced to depend solely on experience and bias in the choice of proper treatment, which can sometimes be misleading. Our well-intended predecessors from the time of Hippocrates would envy our analytic approach to clinical investigation, releasing them from the limitations of leeches, bad humors, and evil spirits in the management of patients with life-threatening disease. Given the importance of the clinical trial process, our greatest challenge as clinical investigators is to ensure that trials yield interpretable results while preserving the safety of study participants. For phase III randomized trials, these issues are typically under the purview of an independent Data and Safety Monitoring Board (DSMB), composed of statisticians
