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Activity Number:
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233
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Type:
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Contributed
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Date/Time:
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Monday, August 3, 2009 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303983 |
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Title:
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Evaluation of Early Endpoints for Go-No Go Decisions in Late-Stage Drug Development
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Author(s):
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Linda Sun*+ and Cong Chen
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Companies:
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Merck & Co., Inc. and Merck Research Laboratories
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Address:
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1258 Jarvis Ln, Lansdale, PA, 19446,
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Keywords:
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Benefit-cost ratio ; Decision analysis ; Expected power ; Oncology
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Abstract:
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Unlike in a Phase III confirmation trial, endpoints used for a Go-No Go decision from a Phase II proof-of-concept (POC) trial to a Phase III registration trial by a drug developer do not necessarily need to meet the stringent regulatory criteria. Usually these endpoints can be measured earlier than the clinical endpoint, and are therefore called early endpoints in this manuscript. The advancement in bioscience and technology has yielded a number of new biomarkers. Different variables can be derived from each biomarker, making it increasingly difficult for drug developers to decide which endpoints to choose in practice. In this paper, we will provide measures for evaluation of candidate early endpoints.
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