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Abstract Details
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Activity Number:
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351
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Type:
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Contributed
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Date/Time:
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Tuesday, August 2, 2011 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #302622 |
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Title:
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A New Statistical Method for Estimating a Clinically Meaningful Threshold
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Author(s):
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Xin Fang*+ and Mahboob Sobhan
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Companies:
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U.S. Food and Drug Administration and U.S. Food and Drug Administration
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Address:
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10903 New Hampshire Ave., Silver Spring, MD, 20903,
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Keywords:
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clinically meaningful threshold ;
negative predicted value ;
positive predicted value
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Abstract:
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A clinically meaningful threshold (CMT) is defined as an efficacy cutoff value. If, for example, a patient's efficacy response is below the CMT, the patient has not experienced a clinically meaningful improvement. Estimates of CMT are usually based on the subjective perspectives of investigators. Currently, there is no statistical method to estimate the CMT objectively. The author have developed and investigated a new two-step statistical methodology for locating the CMT. This method provides a non-traditional approach for establishing the theoretical (or probability) background for each of the four components of a receiver operating characteristic curve. Consequently, both positive predicted value and negative predicted value are used in investigating the threshold. Simulation results will be used to illustrate some of the properties of the derived CMT estimators.
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