Some practical aspects of the interim monitoring of clinical trials.
The decision to stop accrual early to a clinical trial is often difficult and multifaceted. Interim monitoring boundaries have been found useful in U.S. oncology trials for such decisions for reasons described here. This paper also discusses rationale that lead to more conservative approaches to early stopping decisions than are currently employed. A recent initiative of the National Cancer Institute to achieve the objectives of independent data monitoring committees in the phase III clinical trials which it sponsors is also described.
National Cancer Institute, Biometric Research Branch, Rockville, MD 20852.
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D015982:Bias; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data*; D003627:Data Interpretation, Statistical; D005500:Follow-Up Studies; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy* / Q000401:mortality; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D016019:Survival Analysis; D016896:Treatment Outcome; D014481:United States