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Abstract Details
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Activity Number:
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56
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Type:
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Invited
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Date/Time:
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Sunday, July 31, 2011 : 4:00 PM to 5:50 PM
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Sponsor:
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Leadership Support Council
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| Abstract - #300283 |
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Title:
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Optimizing Clinical Trial Design to Maximize Market Access Success
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Author(s):
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Grace Song-ye Park*+ and Christine Anne Fletcher
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Companies:
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Amgen Inc.
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Address:
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One Amgen Center Drive, Thousand Oaks, CA, 91320, USA
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Keywords:
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clinical trial design ;
market access ;
evidence generation ;
comparative effectiveness
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Abstract:
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With the increasing use of comparative effectiveness research (US) and relative effectiveness (Europe), it is vital that clinical trials are designed to meet both the needs of regulators and payers. Whilst the requirements of evidence generated from clinical trials for regulators and payers can be similar in some aspects, e.g. a randomized controlled trial provides highest level of evidence of efficacy and safety, in many other aspects there is huge divergence in what is expected, for example, outcomes of interest and comparators studied. Optimizing clinical trial designs in a program to maximize product labeling and market access success will result in faster time to market, so statisticians involved in designing clinical trials can significantly influence strategies.
This presentation will discuss key challenges in designing clinical trials for market access success and propose recommendations.
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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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