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Activity Number:
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14
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Type:
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Topic Contributed
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Date/Time:
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Sunday, August 3, 2008 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301090 |
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Title:
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Using Propensity Scoring Methods in Medical Device Studies That Include Both FDA Approval and CMS Reimbursement Endpoints
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Author(s):
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Dennis King*+
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Companies:
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STATKING Consulting, Inc.
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Address:
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759 Wessel Drive , Fairfield, OH, 45014,
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Keywords:
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CMS Reimbursement ; FDA Approval ; Design of Medical Device Studies
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Abstract:
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Without reimbursement approval from CMS for a medical device, an FDA approved device is likely to be underutilized in the marketplace. Some authors have suggested the specification of endpoints and the collection of data to support both FDA approval and a favorable CMS reimbursement decision be integrated into clinical study protocols. Many pivotal trials for medical devices are observational studies in which the investigator has little or no control over the treatment assignment. Propensity score analysis methods have been used in the analysis of data from this type of clinical study to adjust the causal treatment effect for covariates. In this talk, the use of propensity score methods will be discussed in the context of FDA approval endpoints and CMS reimbursement endpoints.
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