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Independent data monitoring committees (IDMCs) were introduced to monitor patient safety and study conduct in randomized clinical trials (RCTs), but certain challenges regarding the utilization of IDMCs have developed. First, the roles and responsibilities of IDMCs are expanding, perhaps due to increasing trial complexity and heterogeneity regarding medical, ethical, legal, regulatory, and financial issues. Second, no standard for IDMC operating procedures exists, and there is uncertainty about who should determine standards and whether standards should vary with trial size and design. Third, considerable variability in communication pathways exist across IDMC interfaces with regulatory agencies, academic coordinating centers, and sponsors. Finally, there has been a substantial increase in the number of RCTs using IDMCs, yet there is no set of qualifications to help guide the training and development of the next generation of IDMC members. Recently, an expert panel of representatives from government, industry, and academia assembled at the Duke Clinical Research Institute to address these challenges and to develop recommendations for the future utilization of IDMCs in RCTs.

Background We describe a review of published main reports of randomized controlled trials (RCTs), in order to measure the frequency of reported use of data monitoring committees (DMCs) and factors associated with reported DMC use. Methods Twenty-four higher impact general and specialist medical journals were handsearched for main reports of RCTs in order to provide a cross-sectional sample of trials published in the year 2000. Additionally, the same general medical journals were handsearched for 1990 to allow a comparison across time. Results Of 662 RCTs published in 2000, 120 (18%) explicitly reported using a DMC, while 107 (16%) reported planned interim analyses. Overall, about a quarter (24%) reported at least one of these. A higher proportion of trials reported using a DMC in 2000 than 1990 (70/282, 25% versus 21/204, 10%) in the general medical journals. Logistic regression models suggested the more important variables associated with increased reported DMC use were: later year of publication, publication in general medical journal, survival-based endpoint, multicentre trial, increasing number of patients recruited, at least one arm involving a placebo, at least one arm involving a drug, factorial design and USA involvement in the trial. Conclusions In 2000, about a quarter of main RCT reports mention use of a DMC. Actual use of DMCs is likely to be somewhat greater. Reporting use of a DMC was more likely for larger and longer trials among other factors. We believe the factors affecting reported use affect actual use. It is recommended that when a DMC oversees a trial, brief details should be explicitly included in the main trial paper. Standard nomenclature for DMCs is recommended.