JSM 2004 - Toronto

Abstract #300395

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Activity Number: 12
Type: Topic Contributed
Date/Time: Sunday, August 8, 2004 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300395
Title: Phase 2/3 Combination Designs Comparing Several with a Control
Author(s): Qing Liu*+
Companies: J&J Pharmaceutical Research and Development
Address: 920 Route 202, PO Box 300, Raritan, NJ, 08869,
Keywords: adaptive design ; adaptive closed-testing procedure ; Dunnett test
Abstract:

We propose a phase 2/3 combination design for late-stage clinical development to identify a more effective treatment than a standard control among several experimental treatments. The design consists of two stages. In the first stage, patients are randomized to one of the several treatments or control. At the end of the first stage, short-term safety and efficacy are examined, upon which promising treatments are selected for further evaluation. The required sample size and method of analysis are also determined. In the second stage, newly enrolled patients are randomized to only one of the selected treatments or control; and patients for the selected treatments or control, including those enrolled in the first stage, are evaluated using a clinical endpoint requiring a longer follow-up. At the end of the second stage, data of both stages from patients randomized to one of the selected treatments or control are integrated for final hypothesis testing via an adaptive closed-test procedure. A notable feature is that the decision rule governing regimen selection, sample size calculation, and method of analysis need not be specified in advance to maintain the validity of the trial.

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Revised March 2004