Stopping rule

In Safety & pharmacovigilance

A stopping rule is a pre-specified condition under which a trial, or part of it, will be halted. Rules can be for harm, for clear benefit, or for futility when continuing could not plausibly show an effect. Defining them in advance stops the decision from being made after the fact on the basis of the results.

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Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.