Journal title
Regulatory Rapporteur
Issue
5
Volume
10
Last updated
2023-06-25T00:53:51.52+01:00
Page
5-8
Abstract
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.
Symplectic ID
513216
Submitted to ORA
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Publication type
Journal Article
Publication date
06 May 2013