Data monitoring committees and capturing relevant information of high quality.
The integrity and credibility of randomized clinical trials, designed to provide a definitive evaluation of therapeutic interventions, can be substantially enhanced if periodic review of results on the relative efficacy of treatments is conducted by a data monitoring committee (DMC). The role of the DMC can include some important activities which promote obtaining relevant information of high quality. In the final stage of study development, these include review of protocol-specified study objectives and design, and review of procedures planned for capturing high-quality data and for reporting to the DMC. At analyses during the trial, these include careful review of data completeness and accuracy to assist in early detection and resolution of evolving problems.
Fleming
T R
TR
Department of Biostatistics, University of Washington, Seattle 98195.
D002986:Clinical Trials as Topic / Q000592:standards*; D004989:Ethics; D006801:Humans; D011367:Professional Staff Committees; D016032:Randomized Controlled Trials as Topic / Q000592:standards; D012107:Research Design / Q000592:standards; D013223:Statistics as Topic; D014481:United States