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Activity Number:
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374
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 9, 2006 : 8:30 AM to 10:20 AM
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Sponsor:
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Section on Statistics in Epidemiology
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| Abstract - #305959 |
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Title:
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Statistical Issues in Incorporating and Testing Biomarkers in Clinical Trials
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Author(s):
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Daniel Sargent*+ and Sumithra Mandrekar
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Companies:
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Mayo Clinic College of Medicine and Mayo Clinic College of Medicine
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Address:
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Kahler 1A, Rochester, MN, 55905,
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Keywords:
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biomarker ; clinical trial ; phase I ; phase II ; phase III
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Abstract:
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Novel therapies are challenging drug development. Many new therapies have mechanisms of action aimed at specific molecular targets whose efficacy is expected to be limited to patients with a certain biomarker, and/or have a purported biomarker to measure the agent's efficacy. This raises issues in phase I, II, and III clinical trial design. We will present novel designs to identify optimal doses of a single or two-drug combination in Phase I trials utilizing both toxicity and efficacy. Next, we will discuss single-arm or randomized Phase II trials where a biomarker dictates patient selection and/or treatment. Finally, we will discuss confirmatory biomarker-based Phase III trials where the drug's mechanism of action is known and a reliable assay is established. We believe rational use of biomarkers will facilitate drug development and ultimately help deliver individualized therapy.
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