JSM 2004 - Toronto

Abstract #300238

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Activity Number: 142
Type: Invited
Date/Time: Monday, August 9, 2004 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300238
Title: ASTIN--A Bayesian Dose-response Finding Study in Acute Stroke
Author(s): Michael Krams*+
Companies: Pfizer Inc.
Address: ClinSci CNS, Eastern Point Rd., Groton, CT, 06340,
Keywords: Bayesian ; dose-response ; adaptive ; clinical ; sequential ; interim
Abstract:

ASTIN was an international phase II study to establish proof-of-concept for a novel neuroprotective therapy in acute stroke patients. We successfully deployed a Bayesian sequential design with real-time efficacy data capture, continuous reassessment of the dose-response and adaptive allocation of patients to one of 16 treatment arms. An optimal stopping rule was intended to facilitate termination of the trial for either futility or efficacy at the earliest possible timepoint. Over the period of one year, 966 stroke patients were entered. An independent data monitoring committee reviewed estimates of the dose-response and the probability of futility or efficacy on a weekly basis and stopped the trial prematurely for futility. This talk will highlight the doability of real-time learning in clinical drug development and discuss our experience in developing and implementing the design.

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Revised March 2004