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Activity Number:
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500
- Beyond Randomized Studies: Nonrandomized, Single Arm, or Special Studies
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 2, 2017 : 10:30 AM to 12:20 PM
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Sponsor:
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Section on Medical Devices and Diagnostics
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Abstract #323962
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Title:
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A Bayesian Approach Developed for Single Arm Studies Using Performance Goals with Subgroups
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Author(s):
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Wei-Chen Chen* and Nelson Lu
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Companies:
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FDA/CDRH and CDRH/FDA
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Keywords:
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Performance goal ;
medical device ;
subgroup ;
Bayesian
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Abstract:
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Under some circumstances, a pre-market application of medical devices may be supported by a single arm study where clinical endpoint is compared with a performance goal (PG). Occasionally, the performance is expected to be different between two clinically defined subgroups of patients, and the performance is believed to be positively correlated between two subgroups. It is often proposed to compare the clinical results from a single arm study to a PG that is derived from weighting the two separate PGs of the two subgroups. We propose a Bayesian framework to design such a study and analyze the data. Simulation studies are conducted to evaluate the approach.
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Authors who are presenting talks have a * after their name.
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