This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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584
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Type:
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Contributed
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Date/Time:
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Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #307383 |
Title:
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Expected Frequency of Allowed Forced Allocations in a Multicenter Clinical Trial
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Author(s):
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Suvajit Samanta*+ and Olga Kuznetsova
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Companies:
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Merck Research Laboratories and Merck Research Laboratories
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Address:
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126 E. Lincoln Ave., Rahway, NJ, 07065,
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Keywords:
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Clinical Trial ;
Multi-center trial ;
Forced Allocation ;
Forced Randomization ;
Central Randomization ;
IVRS
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Abstract:
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When the treatment that a patient is supposed to be randomized to is not available at his/her site, the allocation algorithm can assign the patient to an available treatment (forced allocation, McEntegard [2002]). Forced allocation typically occurs in a study which uses a central randomization schedule and IVR (IWR) system for patient allocation and drug distribution. Allowance of forced allocation in a multi-center study may substantially reduce drug supply wastage. In this research, the expected frequency of forced allocations in a study with a large number of centers is computed using an exact method rather than simulations. It will be shown how the frequency of forced allocation changes with the allocation ratio, enrolment rate, and the number of blocks sent to and maintained at the sites. The issues related to forced allocation and its expected frequency will also be discussed.
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Authors who are presenting talks have a * after their name.
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