NBDA Workshop VI: The Ever-Promising but Elusive Surrogate Endpoint: What Will it Take?
December 1-2, 2014
Fairfax at Embassy Row Hotel in Washington, DC.
The sixth in the NBDA's series of workshops aimed at developing a deep understanding of why the biomarker field is fraught with failure. The mission of the NBDA is is to enable the development of strategies (including standards and guidelines) to support an end-to-end process for biomarker development. Over the past months, we have examined in depth, the discovery, development and clinical delivery of biomarkers. This has been an extraordinarily complex process that considered all aspects of biomarker discovery, translation and clinical validation. What we learned in this process is being translated into actions that have the capacity to create the desired outcome - - i.e., predictable end-to-end standards based processes that will support successful biomarker research and development.
Throughout our diligence process, problems and issues surrounding the use of surrogate endpoints (SEs) in clinical trials has come up time and time and time again - and for good reason. Biomarkers that can successfully achieve the FDA's definition of a SE (laboratory measurement or physical sign that can substitute for a clinically meaningful endpoint - i.e., direct measure of how a patient feels, functions, or survives) are indeed few in number. Workshop VI will considered all aspects of the SE – its history, successes and failures. More important, we re-examined the SE in view of advances in the vast array of “omics” possibilities and advanced technologies that will theoretically lead to an entirely new era of precision medicine. Our goal is to agree on the barriers to achieving SEs currently and formulate the strategies and actions to support needed levels of evidence; and perhaps of more importance converge on new approaches to SEs that could integrate advances in the molecular sciences, advanced technologies and entirely new approaches to transform the field in the future.
This information will be available in Spring 2016 to those individuals and organizations that join the NBDA as Partners, Collaborators or Members.