Translational Research Working Group developmental pathway for biospecimen-based assessment modalities.

Publication Type:

Journal Article


Clinical cancer research : an official journal of the American Association for Cancer Research, Volume 14, Issue 18, p.5672-7 (2008)


2008, Evaluation Studies as Topic, Government Regulation, Human Biology Division, Humans, Interdisciplinary Communication, National Institutes of Health (U.S.), Neoplasms, Program Development, Public Health Sciences Division, Reproducibility of Results, Software Design, Tumor Markers, Biological, United States


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.