Using Stata graphs to visually monitor the progress of multicenter randomized clinical trials

Medical randomized trials testing treatments are a complex technology and they require regular attention to assure data quality prior to definitive analysis. Typically, only simple non-graphical methods (tables, proportions) help monitor trial progress, except one graph of cumulative accrual over calendar time; surprisingly, graphical methods are largely ignored for this purpose. For six multicenter trials of the International Atomic Energy Agency, we have developed a graphical approach to data management and trial monitoring, using histograms, scatterplots, dot plots, and cumulative distributions as indicators of overall study and investigator-specific quality. Monthly reports are automated (do-files) and are sent as slideshows by email to investigators and the International Atomic Energy Agency staff. Visual patterns and shapes of curves facilitate early and rapid identification of issues. Clear pictures help investigators to better adhere to a protocol and improve accuracy and completeness of trial data. Visual methods assist in the tracking patients, submitting forms, and clarifying data. Clinical investigators find graphs to be far more intuitive, engaging, efficient, meaningful, and compelling, as compared with conventional tables and text (especially in developing countries where statistical training and language barriers may interfere). This presentation will demonstrate our visual strategy to trial management and explore how this may be optimized.