How will the Data Monitoring Committee (DMC) decide about stopping the trial?
The DMC Charter states that they will reveal the unblinded results to the Trial Steering Committee if, and only if, two conditions are satisfied: (1) the results provide proof beyond reasonable doubt that treatment is on balance either definitely harmful or definitely favourable for all, or for a particular category of, participants in terms of the major outcome; (2) The results would, if revealed, be expected to substantially change the prescribing patterns of doctors who are already familiar with any other trial results that exist. Exact criteria for ‘proof beyond reasonable doubt’ are not, and cannot be, specified by a purely mathematical stopping rule, but they are strongly influence by such rules.
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