Valuation of the use of biomarkers predictive of drug efficacy to enrich responders in oncology drug clinical development
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76838462-MIT.pdf
Description
Full printable version
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2.58 MB
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Checksum (MD5)
e363b2d9e49d277e2144599208a9b9cc
Author(s)
Wine, David
Advisor(s)
A. Gregory Sorensen and Teodro Forcht Dagi.
Date Issued
2006
Publisher
Massachusetts Institute of Technology
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).
Subjects
Harvard University--MIT Division of Health Sciences and Technology.
Sloan School of Management.
MIT Department
Harvard University--MIT Division of Health Sciences and Technology
Sloan School of Management
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