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Activity Number:
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160
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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 : 10:30 AM to 12:20 PM
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Sponsor:
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Section on Statistics in Epidemiology
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| Abstract - #304078 |
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Title:
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Biomarker-Guided Modification to Existing Treatments
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Author(s):
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Rong Tang*+ and Estelle Russek-Cohen
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Companies:
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FDA and FDA
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Address:
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, , 20850,
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Keywords:
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Biomarker ; therapy modification ; prognostic ; clinical trial ; predictive
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Abstract:
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A biomarker may be used to identify patients who can not receive maximum benefit from a current treatment regime and it may also be used to identify those patients that may benefit from a modification of existing treatment to achieve optimum results for these patients. However, there are significant challenges in designing a clinical trial to validate such a biomarker especially in situations where the prognostic value of the marker is not well established. In such situations, the clinical study should be designed to demonstrate both the effectiveness of the marker and the effectiveness of the modified treatment at the same time. There may be ethical concerns that arise in the design of such trials since removing or modifying an already recommended treatment may restrict which study arms can be included in a clinical trial.
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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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