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

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.

Department dc:contributor.department

Harvard University--MIT Division of Health Sciences and Technology.

Grantor dc:publisher

Massachusetts Institute of Technology

Year dc:date.issued

2006

Author dc:creator

• Wine, David

Advisor dc:contributor.advisor

• A. Gregory Sorensen and Teodro Forcht Dagi.

• Harvard University--MIT Division of Health Sciences and Technology.
• Sloan School of Management.

Statement dc:rights

• 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.

Licence dc:rights.uri

• http://dspace.mit.edu/handle/1721.1/7582

Language dc:language.iso

eng

Handle dc:identifier.uri

http://hdl.handle.net/1721.1/35679

OAI identifier oai:identifier

oai:dspace.mit.edu:1721.1/35679