Futility in clinical trials

JAMA

31 July 2023 - The primary objectives of a confirmatory clinical trial, namely a clinical trial conducted with the intention of changing clinical practice or obtaining regulatory approval, are typically to demonstrate and quantify the benefit of a treatment in a specific population of patients. 

Occasionally, accumulating evidence makes it clear that an ongoing clinical trial is unlikely to meet its original goals. When this occurs, the trial may be stopped early for futility. Futility may result from lack of evidence supporting the desired benefit, from evidence of harm, or from practical issues that make successful completion unlikely.

Read JAMA Guide to Statistics and Methods

Michael Wonder

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Michael Wonder

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Medicine , US , Clinical trial