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

Sudhir Srivastava¹, Joe W Gray, Brian J Reid

¹Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland, USA. ehawk@mdanderson.org

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research

|September 17, 2008

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The Translational Research Working Group (TRWG) developed a pathway model to advance biomarker assay development for cancer research. This framework aims to streamline the transition of candidate assays into clinical testing, addressing key challenges in biomarker discovery and validation.

Area of Science:

Oncology
Biomarker Discovery
Translational Research

Background:

The National Cancer Institute established the Translational Research Working Group (TRWG) to assess and shape its investment in translational research.
Translational research is conceptualized as six developmental pathways to achieve clinical goals.

Purpose of the Study:

To introduce a conceptual pathway for biospecimen-based assay development within translational research.
To discuss challenges in biomarker development using this pathway as a framework.

Main Methods:

Conceptualization of a biospecimen-based assessment modality pathway.
Review of prior work and existing challenges in biomarker development.

Main Results:

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The biospecimen-based assessment modality pathway serves as a tool to facilitate assay progression.
The pathway is not an exhaustive description but a facilitator for translational processes.

Conclusions:

The proposed pathway offers a structured approach to biomarker assay development in cancer research.
Addressing identified challenges is crucial for advancing candidate assays to clinical validation.