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

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).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.by David Wine.S.M