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Abstract Details
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Activity Number:
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351
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Type:
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Contributed
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Date/Time:
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Tuesday, August 2, 2011 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301274 |
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Title:
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When Is a Biomarker-Based Study Design in Drug Development Likely to Succeed?
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Author(s):
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Deepak B. Khatry*+
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Companies:
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MedImmune, Inc.
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Address:
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One Medimmune Way, Gaithersburg, MD, 20878,
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Keywords:
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Biomarker ;
Diagnostics ;
Adaptive design ;
Clinical trial ;
Personalized healthcare ;
Stratified medicine
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Abstract:
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Advances in technology enable us to measure previously unquantifiable biological products with increasing precision, promising an era of personalized healthcare. Biomarker tools, if properly utilized as diagnostic (Dx) devices, can increase the overall efficiency in bringing a new therapy to market. Such an increase in efficiency can benefit drug industry and patients alike by reducing development cost, increasing probability of trial success, and increasing benefit/risk ratio for targeted patient subgroups. An important question is when to pursue a biomarker-based design over the traditional randomized control trial (RCT) design. Aside from considerations of market share and profits, there are statistical considerations that determine whether investment in a biomarker-based study design should be made. Three interrelated statistical considerations are the anticipated effect size, preval
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Authors who are presenting talks have a * after their name.
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