JSM 2004 - Toronto

Abstract #301372

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Activity Number: 156
Type: Contributed
Date/Time: Monday, August 9, 2004 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301372
Title: Modified Intention-to-treat Analysis in Clinical Trials
Author(s): Chunqin Deng*+
Companies: PPD Development, Inc.
Address: Research Triangle Park, Morrisville, NC, 27560,
Keywords: intention-to-treat ; modified intention-to-treat ; clinical trial ; per-protocol
Abstract:

Intention-to-treat (ITT) analysis has been widely accepted for the analysis of controlled clinical trials and is now part of several guidelines and recommendations. Strictly, the ITT analysis should include all randomized subjects, regardless of their adherence with the entry criteria, the treatment they actually received, and subsequent withdrawal from treatment or deviation from the protocol. While ITT preserves the initial randomization and minimizes the bias, there are situations where the ITT analysis is not practical or other alternatives may be more appropriate. Modified intention-to-treat (mITT) is a subset of the ITT population and allows the exclusion of some randomized subjects in a justified way. In the recently published results from several controlled clinical trials, mITT analysis has been used. In the pharmaceutical industry, it is not uncommon that under the cap of the ITT, the mITT is actually defined and used for the primary analysis. Using the examples from the real world in clinical trials, we discuss how mITT is defined, when mITT can be used, and how mITT is different from ITT, per-protocol, and other analysis populations.

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