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Valuation of the use of biomarkers predictive of drug efficacy to enrich responders in oncology drug clinical development

Author(s)
Wine, David
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Other Contributors
Sloan School of Management.
Advisor
A. Gregory Sorensen and Teodro Forcht Dagi.
Terms of use
M.I.T. theses are protected by copyright. They may be viewed from this source for any purpose, but reproduction or distribution in any format is prohibited without written permission. See provided URL for inquiries about permission. http://dspace.mit.edu/handle/1721.1/7582
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Abstract
I study several aspects of the value in performing oncology clinical trials using screening biomarkers to preferentially select and enroll responders. From trial reports and investigational reports on potential biomarkers, I construct a series of six cases comparing the trial as conducted to a hypothetical trial using different screening and eligibility criteria. These cases illustrate, within limits of the model, what difference the use of a plausible biomarker test may have on trial size, cost, number of patients screened, and number of patients exposed to experimental treatment without benefit.
Description
Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology; and, (S.M.)--Massachusetts Institute of Technology, Sloan School of Management, 2006.
 
Includes bibliographical references (leaves 57-59).
 
Date issued
2006
URI
http://hdl.handle.net/1721.1/35679
Department
Harvard University--MIT Division of Health Sciences and Technology; Sloan School of Management
Publisher
Massachusetts Institute of Technology
Keywords
Harvard University--MIT Division of Health Sciences and Technology., Sloan School of Management.

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