An audit strategy for time-to-event outcomes measured with error: application to five randomized controlled trials in oncology.

ABSTRACT:

Background

Measurement error in time-to-event end points complicates interpretation of treatment effects in clinical trials. Non-differential measurement error is unlikely to produce large bias [1]. When error depends on treatment arm, bias is of greater concern. Blinded-independent central review (BICR) of all images from a trial is commonly undertaken to mitigate differential measurement-error bias that may be present in hazard ratios (HRs) based on local evaluations. Similar BICR and local evaluation HRs may provide reassurance about the treatment effect, but BICR adds considerable time and expense to trials.

Methods

We describe a BICR audit strategy [2] and apply it to five randomized controlled trials to evaluate its use and to provide practical guidelines. The strategy

SUBMITTER: Dodd LE 

PROVIDER: S-EPMC7511980 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature