Statistical Thinking for Non-Statisticians in Drug Regulation by Richard Kay

Author:Richard Kay [Kay, Richard]
Language: eng
Format: azw3, pdf
ISBN: 9781118470978
Publisher: Wiley
Published: 2014-10-23T04:00:00+00:00

ICH E9 (1998): ‘Note for Guidance on Statistical Principles for Clinical Trials'

‘If no procedure for dealing with outliers was foreseen in the trial protocol, one analysis with the actual values and at least one other analysis eliminating or reducing the outlier effect should be performed and differences between their results discussed'.

Chapter 12

Equivalence and non-inferiority

12.1 Demonstrating similarity

In this chapter, we will move away from superiority trials to look at methods for the evaluation of equivalence and non-inferiority. The setting in all cases here is the comparison of a new treatment to an active control where we are looking to demonstrate similarity (in some defined sense) between the two treatments.

It should be clear from our earlier development, especially the discussion in Sections 9.2 and 9.3, that obtaining a non-significant p-value in a superiority evaluation does not demonstrate that the two treatments are the same or even similar; a non-significant p-value may simply be the result of a small trial, with low power even to detect large differences. ICH E9 makes a clear statement in this regard.

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