6 May 2013
This article outlines a simple, impartial framework for judging the integrity of quantitative evidence in regulated clinical trials. It discusses how data-based evidence should be judged as "fit for purpose" on three fronts: whether the evidence is "appropriate", whether it is "adequate", and whether it is "reliable". Paying considered attention to the suggested numerical topics should increase the review success of a submitted dossier.
Submitted to ORA: