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Activity Number:
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204
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 3, 2009 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303809 |
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Title:
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Optimizing Decision Rules for Trial Device Responder Identification
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Author(s):
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Jeng Mah*+
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Companies:
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Regulatory and Clinical Research Institute, Inc.
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Address:
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Wayzata Boulevard, Suite 505, Minneapolis, MN, 55416,
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Keywords:
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responder ; trial device ; prediction ; predictive probabiity
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Abstract:
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Many implantable medical devices have less-invasive temporary versions that can serve as easily removable trial devices to gauge patient response before a permanent implant; this effectively combines therapy and diagnosis to boost the efficacy of the medical device. However, the decision of whether or not a patient's trial response warrants a permanent implant is often deterministic and likely suboptimal. For example, if a 50% pain reduction is the desired effect of a permanent device, the same threshold is used in the pass/fail decision of a trial device, disregarding inherent uncertainties in subject response. This paper examines incorporating intra-subject variability to optimize the threshold used when making the pass/fail decision for permanent implant. Frequentist modeling and Bayesian prediction are evaluated. Optimal decision rules are sought through simulations.
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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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