. "Appendix A: Table of Papers About Biomarker Qualification." Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press, 2010.
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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease
Year
Author
Focus
Field/Summary and Commentary
Baker et al.
Review
Drug Development
A general framework for describing various roles for biomarkers in cancer prevention research (early detection, surrogate endpoint, and cohort identification for primary prevention) and the phases in their evaluation.
2005
Fleming
Review
Methodology
Surrogate endpoints and FDA’s accelerated approval process.
Sargent et al.
Statistics
Oncology
Meta-analytic approach for surrogate validation.
Baker, 2006a
Statistics
Methodology
A simple meta-analytic approach for using a binary endpoint to predict the effect of intervention on true endpoint.
Korn et al.
Statistics
Methodology
Assessing surrogates as trial endpoints using mixed models.
2006
Weir and Walley
Statistics
Review
Statistical evaluation of biomarkers as surrogate endpoints: A literature review.
Baker, 2006b
Statistics
Review
Title: Surrogate endpoints: Wishful thinking or reality?
Finley Austin and Babiss
Review
Methodology
Where and how could biomarkers be used in 2016?
Qu and Case
Statistics
Statistics
Quantifying the indirect treatment effect via surrogate markers.
Desai et al.
Review
Cardiology
Blood pressure as an example of a biomarker that functions as a surrogate.
Hughes
Review
HIV Medicine
Initial treatment of HIV Infection: Randomized trials with clinical endpoints are still needed.
