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Abstract Details
Activity Number:
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405
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Type:
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Contributed
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Date/Time:
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Tuesday, July 31, 2012 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #305349 |
Title:
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A Patient Recruitment Mixed Distribution Model with Center Initiation Cycle Times
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Author(s):
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James Powers*+
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Companies:
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Quintiles, Inc.
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Address:
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5927 S Miami, Morrisiville, NC, 27560, United States
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Keywords:
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clinical trial ;
recruitment ;
Poisson-gamma model ;
Clinical Trial Design from Miscellaneous. ;
center initiation
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Abstract:
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Global, multi-center clinical trials require careful planning not only for statistical design but also to create a strategy for clinical center regulatory processes and patient recruitment targets. Anisimov and Fedorov (2007) present a Poisson-mixed-with-gamma approach to patient recruitment, which can be viewed a double-stochastic process.
Practical application of that method has led to a number of practical extensions, as we add time-to-center initiation as an important cycle time. Further, we have modeled country and region-specific characteristics that lead to an overall re-finement of the application of this method. The strategic decisions have an impact on time lines and ultimately overall development strategy for the compound.
We discuss the theoretical and practical challenges of center initiation and patient recruitment, combined, presenting closed-form and simulated results t
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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