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Activity Number:
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377
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Type:
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Contributed
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Date/Time:
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Tuesday, August 4, 2009 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304307 |
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Title:
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Flexibility and Integrity Planning in Phase IIb, 2-Stage Adaptive Dose-Ranging Acute Migraine Trials
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Author(s):
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Christopher Assaid*+ and Frank (Xiaoyin) Fan and Joy (Yang) Ge
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Companies:
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Merck & Co., Inc. and Merck & Co., Inc. and Merck Research Laboratories
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Address:
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UG 1C-46, POB 1000, North Wales, PA, 19454,
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Keywords:
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Randomization ; Adaptive ; Integrity ; Flexibility
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Abstract:
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The complexities of both the design and implementation challenges of adaptive dose-ranging designs are well-known. In this presentation we describe approaches to address implementation challenges and opportunities that can be somewhat unique to adaptive dose-ranging designs in acute migraine trials. Some of these unique aspects include potential lag between randomization and treatment, single dose treatment, short time lapse between treatment and the primary timepoint, relative absence of missing data, limit on the number/size of pills/capsules that can be administered, and a sponsor's desire to investigate the safety and efficacy of repeat dosing. We will discuss strategies used to handle and capitalize on these challenges/opportunities across multiple adaptive dose-ranging acute migraine trials, both from a logistical standpoint as well as an integrity-planning standpoint.
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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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