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Activity Number:
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597
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 3, 2016 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #319392
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Title:
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Patient Preference in Benefit-Risk Analysis in Medical Device Trials
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Author(s):
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Xuefeng Li*
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Companies:
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FDA
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Keywords:
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Benefit Risk ;
Patient Preference ;
Medical device
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Abstract:
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The Center for Devices and Radiological Health (CDRH) has recently started a new strategic priority - collecting and using patient preference in regulatory decision making. FDA believes that patients can and should bring their own experiences to bear in helping the Agency evaluate the benefit-risk profile of certain devices. A relevant draft guidance was released last May and the main objectives of this draft guidance are to outline current agency thinking of patient preference information and to provide recommendations for collecting patient preference information to FDA. In 2015, the Medical Device Innovation Consortium (MDIC) also released a patient centered benefit-risk project report, outlining 14 available quantitative methods for eliciting patient preferences. In this presentation I will talk about the CDRH draft guidance and discuss the available quantitative methods for eliciting patient preferences in medical device arena.
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Authors who are presenting talks have a * after their name.
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