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Activity Number:
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161
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Type:
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Luncheons
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Date/Time:
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Monday, August 7, 2006 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305825 |
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Title:
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New Development and Challenges in Phase I and Phase I/II Dose-Finding Studies
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Author(s):
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Weili He*+
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Companies:
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Merck & Co., Inc.
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Address:
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1129 Blvd., Westfield, NJ, 07090,
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Keywords:
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Abstract:
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The primary goal of a phase I cancer clinical trial is to determine the maximum tolerated dose (MTD) to be used for subsequent phase II and III trials evaluating efficacy. There are two schools of thought in designing phase I cancer clinical trials: one treats the MTD as being observed from the data and the other treats the MTD as a parameter to be estimated from a model. Diverse opinions have been expressed in strong support of one design over the other, and there has been no clear guidance on the choice of a design. The intention of this roundtable is for people who are interested in this area to discuss their ideas of design choices and share new development and challenges in designing a phase I and phase I/II dose-finding study.
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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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