Interpreting the results of intention to treat, per protocol and as treated analyses of clinical trials

JAMA

 3 August 2021 - Non-adherence in a randomised clinical trial occurs when study participants do not follow the randomly assigned treatment protocol. 

Reasons for non-adherence may include the study participant not taking trial medications, crossing over to the other intervention being studied, or accessing treatment outside of the trial. 

Non-adherence also may occur when the clinician is unable to complete the assigned therapy (eg, a surgical procedure) as intended.

Read JAMA Guide to Statistics and Methods

Michael Wonder

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Michael Wonder

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Medicine , US , Clinical trial , Bias