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Translational Research Working Group Developmental Pathway for Biospecimen-Based Assessment Modalities

Authors' Affiliations: ¹ Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland; ² Lawrence Berkeley National Laboratory, Berkeley, California; ³ Fred Hutchison Cancer Research Center, Seattle, Washington; ⁴ Science and Technology Policy Institute, Wellesley, Massachusetts; and ⁵ Office of Communications, and ⁶ Office of Centers, Training, and Resources, National Cancer Institute, Bethesda, Maryland

Requests for reprints: Ernest Hawk, Division of Cancer Prevention & Population Sciences, Unit 1370, University of Texas M. D. Anderson Cancer Center, PO Box 301439, Houston, TX 77230-1439. Phone: 713-792-3900; Fax: 713-792-0629; E-mail: ehawk{at}mdanderson.org.

Abstract

The Translational Research Working Group (TRWG) was created as a national initiative to evaluate the current status of National Cancer Institute's investment in translational research and envision its future. The TRWG conceptualized translational research as a set of six developmental processes or pathways focused on various clinical goals. One of those pathways describes the development of biospecimen-based assays that use biomarkers for the detection, diagnosis, and prognosis of cancer and the assessment of response to cancer treatment. The biospecimen-based assessment modality pathway was conceived not as comprehensive description of the corresponding real-world processes but rather as a tool designed to facilitate movement of a candidate assay through the translational process to the point where it can be handed off for definitive clinical testing. This paper introduces the pathway in the context of prior work and discusses key challenges associated with the biomarker development process in light of the pathway.

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