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Perspectives on Biomarker and Surrogate Endpoint Evaluation - Discussion Forum Summary (Paperback)
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Perspectives on Biomarker and Surrogate Endpoint Evaluation - Discussion Forum Summary (Paperback)
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In 2010 the Institute of Medicine (IOM) recommended a framework for
the evaluation of biomarkers in the chronic disease setting.
Published in the book Evaluation of Biomarkers and Surrogate
Endpoints in Chronic Disease, the framework is intended to bring
consistency and transparency to the previously disparate process of
biomarker evaluation. Following the book's release, the IOM
convened a 2-day discussion forum in Washington, DC, in order to
provide an opportunity for stakeholders to learn about, react to,
and discuss the book. Presentations reviewed the authoring
committee's work process, recommendations, and provided
perspectives on the book from the point of view of participants.
Thomas Fleming, professor of biostatistics and statistics at the
University of Washington, gave a keynote presentation on the
critical issues in the validation of surrogate endpoints, a
specific use of a biomarker. The present volume recounts the
discussion forum proceedings, focusing in turn on each represented
sector. A summary of Dr. Fleming's presentation then sets the
committee's recommendations within the context of biomarker
utilization. Lastly, this summary examines the main themes raised
by stakeholders, and the challenges and opportunities presented to
stakeholders by the book's recommendations. Table of Contents Front
Matter 1 Introduction 2 Committee Findings and Recommendations 3
FDA Perspectives 4 National Institutes of Health Perspectives 5
Industry Perspectives 6 Public Health, Consumer, and Consulting
Organization Perspectives 7 Presentation by Thomas Fleming:
Biomarkers and Surrogate Endpoints in Chronic Disease 8 Key Themes,
Challenges, and Opportunities 9 Importance of the Biomarker
Discussion Forum References Acronyms Glossary Appendix A:
Discussion Forum Agenda Appendix B: Summary from the Committee's
Report *Evaluation of Biomarkers and Surrogate Endpoints in Chronic
Disease*
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