Abstract #301821

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JSM 2003 Abstract #301821
Activity Number: 31
Type: Contributed
Date/Time: Sunday, August 3, 2003 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301821
Title: Designs, Power, and Sample Size for a NonStop Drug Development Strategy
Author(s): John D. Johnson*+
Companies: Rho, Inc.
Address: 100 Eastowne Dr., Chapel Hill, NC, 27514-2286,
Keywords: clinical trials ; group sequential ; power ; sample size ; design
Abstract:

A NonStop drug development strategy leverages the power of group sequential designs to shorten the drug development cycle and reduce the cost of drug testing. The goal of the strategy is to establish a treatment regimen as quickly as possible and move into Phase III (confirmatory) trials. Pruning ineffective or unsafe regimens early is paramount. The roles of significance and power must be reconsidered in a NonStop setting. Appropriate designs are group sequential with random sample sizes. These issues, along with the important issue of making the complicated statistics accessible to practitioners, are discussed. An example based on a real NonStop trial is presented.

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