Strength of accumulating evidence and data monitoring committee decision making.
The data monitoring committee (DMC) is a vital component of a randomized clinical trial. Its responsibilities include stopping the trial early for extreme results. The decision to stop the trial must be based on a careful synthesis of statistical methodology and clinical judgment. It is critical to ensure the validity of this complex process. In this paper we present results of a survey of 21 DMC members conducted to investigate how they evaluate accumulating evidence. The results indicate that some DMC members may be over-interpreting developing trends in the data.
George
Stephen L
SL
Department of Biostatistics and Bioinformatics, Box 3958, Duke University Medical Center, Durham, NC 27710, USA. stephen.george@duke.edu
Freidlin
Boris
B
Korn
Edward L
EL
D000970:Antineoplastic Agents / Q000627:therapeutic use; D026661:Clinical Trials Data Monitoring Committees; D003627:Data Interpretation, Statistical; D003657:Decision Making; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy / Q000401:mortality; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D011795:Surveys and Questionnaires; D016019:Survival Analysis
D000970:Antineoplastic Agents