Abstract #300047

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JSM 2002 Abstract #300047
Activity Number: 341
Type: Invited
Date/Time: Wednesday, August 14, 2002 : 2:00 PM to 3:50 PM
Sponsor: ENAR
Abstract - #300047
Title: Is the Road to Drug Registration Paved with Good Intentions to Treat?
Author(s): Michael Nessly*+
Affiliation(s): Merck Research Laboratories
Address: P.O. Box 4, West Point, Pennsylvania, 19486,
Keywords: clinical trials ; randomization ; attrition bias ; intention-to-treat ; analyzable populations ; drop outs
Abstract:

First, the rationale behind the intention to treat approach will be presented. Several authoritative, yet varying, definitions of what constitutes ITT will be discussed. The regulatory guidelines (ICH and FDA Guidelines, EMEA Points to Consider) will be discussed. Examples of approaches utilized (and mandated by regulatory agencies) for several Phase III pivotal studies, from differing clinical programs (different FDA reviewing divisions), will be presented. These examples were the evidential basis of successful submissions. These examples range from ITT in the strong sense, through ITT in the weak sense, to NOT ITT. Presentation methods for complete patient accounting in clinical trials will be presented.

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Revised March 2002