JSM 2011 Online Program

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Abstract Details

Activity Number: 516
Type: Contributed
Date/Time: Wednesday, August 3, 2011 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #302445
Title: A Three-Part Adaptive Design with POC and Dose-Finding for Induction Regimen and Dose-Finding for Maintenance Regimen for an Immunology Trial
Author(s): Usha Barai*+
Companies: Merck Research Laboratories
Address: 2015 Galloping Hill Road, Kenilworth, NJ, 07033-1300,
Keywords: Adaptive ; POC ; Induction Dose Finding ; Maintenance Dose Finding ; Futility ; Dropping/Adding Doses
Abstract:

In certain disease area like Crohn's disease (CD), it is important to establish optimal induction as well as maintenance dose regimen. This three Part trial incorporates Proof of Concept (POC), Induction Dose Finding and Maintenance Dose Finding using adaptive features like futility, dropping/adding induction doses and optimizing maintenance doses based on modeling. We will discuss important features of the trial design including interim analyses with quantitative decision criteria based on the results of the simulation studies and practical issues in adaptive designs.


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