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Activity Number: 102
Type: Topic Contributed
Date/Time: Monday, August 3, 2009 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #303882
Title: Interim Enrollment Adjustment
Author(s): Valerii V. Fedorov*+ and Frank Mannino
Companies: GlaxoSmithKline and GlaxoSmithKline
Address: 1250 S Collegeville Rd, Collegeville, PA, 19426,
Keywords: design clinical trials ; Gamma-Poisson model
Abstract:

In the design of large clinical trials the sound selection of the number of centers involved a trial is an optimization problem that depends on uncertain prior information and potential (random) changes during this trial. The interim corrections, for instance, adding new centers helps to mitigate the role of those uncertainties. We address the problem using the Poisson or Gamma-Poisson model for the enrollment process and the Bayesian approach for updating estimators of their parameters.


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