The Ethics of Early Stopping Rules: Who Is Protecting Whom?

摘要: Well-conducted clinical investigation, in concert with basic laboratory research, is the cornerstone for progress medicine. Without it, we are forced to depend solely on experience and bias choice of proper treatment, which can sometimes be misleading. Our well-intended predecessors from time Hippocrates would envy our analytic approach releasing them limitations leeches, bad humors, evil spirits inthemanagementofpatientswithlife-threateningdisease. Giventheimportanceoftheclinicaltrialprocess,ourgreatest challenge as investigators ensure that trials yield interpretable results while preserving safety study participants. For phase III randomized trials, these issues typically under purview an independent Data Safety Monitoring Board (DSMB), composed statisticians not directly involved study. The DSMB responsible reviewing data, performing interim analyses when reaches its specified number events, deciding whether or close basis predetermined early stopping rules relate toxicity outcome. If excess harm observed, if a statistically significant benefit stopped patient informed results. treatment ongoing,