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Activity Number:
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252
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Type:
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Invited
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Date/Time:
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Tuesday, August 4, 2009 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #302777 |
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Title:
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Adaptive Design: Where Are We Now?
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Author(s):
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Frank Bretz*+ and H.M. James Hung*+ and Armin Koch*+ and Chris Jennison*+ and Robert O'Neill*+ and Jerry Schindler*+ and Robert Temple*+
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Companies:
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Norvartis, Switzerland and FDA and Federal Institute for Drugs and Medical Devices and University of Bath and FDA and Merck Research Laboratories and FDA
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Address:
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, , , CDER, 10903 New Hampshire Avenue, Silver Spring, MD, 20993-0002, BfArM, D 53175 Bonn, International, , Germany , Bath, , United Kingdom CDER, 10903 New Hampshire Avenue, Silver Spring, MD, 20993-0002, , West Newton, MA, 02465-2619, 10903 New Hampshire Avenue, Silver Spring, MD, 20993,
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Keywords:
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Adaptive Design ; draft guidance ; early phase ; late phase
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Abstract:
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Fundamental statistical methodologies for adaptive designs are almost saturated, though methodological development on more adaptive approaches continues. Since 2000, the enthusiasm about adaptive designs being potential panacea and the push for adaptive designs to be employed in the clinical trials have taken the pharmaceutical drug development a fresh look about novel and potentially innovative designs beyond the usual fixed designs. Many workshops and special issues of professional statistical journals have focused on the adaptive design or flexible design topics over these years. In October 2007, Committee for Medicinal Products for Human Use of European Medicines Agency published the Reflection Paper on Methodological Issues in Confirmatory Clinical Trials Planned with an Adaptive Design.
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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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