What is it about?
This paper defines unmet clinical need in the context of biomarker development. Using an outcome-focused approach, the paper provides a strategy and checklist for needs assessment intended for use by multiple stakeholders.
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Why is it important?
This paper addresses the often neglected pre-discovery phase of medical test evaluation; identifying and validating unmet clinical needs in the development of novel biomarkers.
Perspectives
Biomarker development is an inefficient process, in part due to a disconnect between the 'push' of technology innovation and the 'pull' of clinical need. This paper aims to provide a practical tool for a multi-stakeholder approach to aid the identification and validation of clinical needs for novel biomarkers, therefore increasing test performance within the clinical pathway, whilst at the same time minimising research waste.
Dr Phillip J Monaghan
The Christie Pathology Partnership
Read the Original
This page is a summary of: Biomarker development targeting unmet clinical needs, Clinica Chimica Acta, September 2016, Elsevier,
DOI: 10.1016/j.cca.2016.06.037.
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