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Activity Number:
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130
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Type:
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Invited
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Date/Time:
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Monday, July 30, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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ENAR
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| Abstract - #307733 |
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Title:
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Issues and Solutions to Planning and Implementing an Adaptive Design in Practice
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Author(s):
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Michael Krams*+ and Paul Gallo*+ and Gernot Wassmer*+ and Jerald S. Schindler*+ and Christopher S. Coffey*+
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Companies:
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Wyeth and Novartis Pharmaceuticals and The University of Cologne and Merck & Co., Inc. and The University of Alabama at Birmingham
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Address:
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500 Arcola Road A-5113, Collegeville, PA, 19426, 419/2114, One Health Plaza, East Hanover, NJ, 07936, Institute for Medical Statistics, Informatics, and Epidemiology, 50937 Cologne, International, 50937, Germany 126 E. Lincoln Avenue, Rahway, NJ, 07065, Department of Biostatistics, Birmingham, AL, 35294,
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Keywords:
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Adaptive Designs ; Flexible Designs ; Data Monitoring Committee ; planning ; NIH
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Abstract:
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Adaptive trial designs can be a valuable addition to the drug development toolkit, but more objective evaluation based on experience with their use in practice is needed. Statistical, logistical, and procedural issues need to be addressed. For example, some key statistical issues are control of the type I error rate and unbiased estimation. Some logistical issues are the timely collection of quality data, and the need for the integration of data capture, drug supply management, and communication between patient/investigator and the randomization center. A key procedural issue is the processes by which interim data is reviewed and decisions are made and implemented in ways to ensure that the integrity of the trial are not compromised. In this session, 5 panel members across academia and industry will discuss issues and practical solutions based on their experiences.
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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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