Appropriate, adequate and reliable - a view on statistical and regulatory evidence in clinical trials

Author: 

Bowman, C
Ligensa, T

Publication Date: 

6 May 2013

Journal: 

Regulatory Rapporteur

Last Updated: 

2020-09-10T09:18:23.373+01:00

Issue: 

5

Volume: 

10

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: 

Not Submitted

Publication Type: 

Journal Article