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

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.

Fig. 1

Biospecimen-Based Assessment Modality (BM) Pathway. The BM pathway is depicted as a flowchart, a schematic process representation widely used in engineering. Rounded rectangle at the top, the origin of the process. Square-cornered rectangles, activity steps. Diamonds, conditional tests or decision steps. Unidirectional arrows, the direction of the activity sequence, and the direction of transfer of supporting tools from their parallel development paths to the main path of modality development. The three diamonds in the initial steps of the pathway (blue) are decisions required to proceed through the pathway and represent the credentialing step. Subsequent steps include the development of supporting tools (red), the creation of the modality (green), preclinical development (purple), and early stage clinical trials (yellow). For each activity or decision point, it is understood that there are many more variations that can occur, and that not all steps may occur in each instance. The pathway does not address the ways in which insights gained from late-stage clinical trials can influence the development process. Biospecimen-based assessment devices can be used for screening, early detection, diagnosis, prediction, prognosis, or response assessment. The pathways are conceived not as comprehensive descriptions of the corresponding real-world processes but as tools designed to serve specific purposes, including research program and project management, coordination of research efforts, and professional and lay education and communication.