Stopping early can be harmful

Some of the randomized clinical trials if stopped early can lead to misleading results in the late phases according to a recent study in the Journal of the American Medical Association. The Randomized clinical trials provide a fair amount of evidence related to side effects. This can only beneficial if conducted as per the exact protocol guidelines.

The tendency of the investigators is such that they tend to halt the trial once they find an apparently beneficial effect of the drug. Therefore the results may therefore provide misleading estimates of the benefit in the final result.

According to the study authors, to the extent that substantial overestimates of treatment effect are widely disseminated, patients and clinicians will be misled when trying to balance benefits, harms, inconvenience, and cost of a possible health care intervention.

As a conclusion from the study authors:

For trial investigators, the results of the study suggest the desirability of stopping rules demanding large numbers of events. For clinicians, they suggest the necessity of assuming the likelihood of appreciable overestimates of effect in trials stopped early.

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