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Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary
supplements, pharmaceuticals, medical diagnostics, and devices; and by representatives of public health, consumer, and nutrition consulting organizations, as well as by members of the committee and IOM staff.
Presentations reviewed the committee’s work process, recommendations, and provided perspectives on the report from the point of view of participants from the FDA, the NIH, and from a diverse group of industry stakeholders; all such sessions were followed by panel discussions. Many presenters emphasized that the views they expressed were theirs and not necessarily those of their organizations or institutions. 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.
This document recounts the discussion forum proceedings, focusing in turn on each represented sector. A summary of Dr. Fleming’s presentation then sets the committee’s report 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 report’s recommendations.