Biomarker development targeting unmet clinical needs
| Autor: | Sverre Sandberg, Andrea R. Horvath, Christoph Ebert, Sarah J. Lord, Patrick M.M. Bossuyt, Andrew St John, Phillip J. Monaghan, Lieselotte Lennartz, Wilma D.J. Verhagen-Kamerbeek, Christa M. Cobbaert |
|---|---|
| Přispěvatelé: | Epidemiology and Data Science |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Consensus
Process (engineering) Clinical Decision-Making Clinical Biochemistry 030204 cardiovascular system & hematology Biochemistry Unmet needs 03 medical and health sciences 0302 clinical medicine Clinical pathway Multidisciplinary approach Humans Medicine 030212 general & internal medicine Medical education Scope (project management) business.industry Biochemistry (medical) General Medicine Checklist Medical test Practice Guidelines as Topic Biomarker (medicine) business Biomarkers |
| Zdroj: | Clinica chimica acta; international journal of clinical chemistry, 460, 211-219. Elsevier |
| ISSN: | 0009-8981 |
| DOI: | 10.1016/j.cca.2016.06.037 |
| Popis: | Background The introduction of new biomarkers can lead to inappropriate utilization of tests if they do not fill in existing gaps in clinical care. We aimed to define a strategy and checklist for identifying unmet needs for biomarkers. Methods A multidisciplinary working group used a 4-step process: 1/ scoping literature review; 2/ face-to-face meetings to discuss scope, strategy and checklist items; 3/ iterative process of feedback and consensus to develop the checklist; 4/ testing and refinement of checklist items using case scenarios. Results We used clinical pathway mapping to identify clinical management decisions linking biomarker testing to health outcomes and developed a 14-item checklist organized into 4 domains: 1/ identifying and 2/ verifying the unmet need; 3/ validating the intended use; and 4/ assessing the feasibility of the new biomarker to influence clinical practice and health outcome. We present an outcome-focused approach that can be used by multiple stakeholders for any medical test, irrespective of the purpose and role of testing. Conclusions The checklist intends to achieve more efficient biomarker development and translation into practice. We propose the checklist is field tested by stakeholders, and advocate the role of the clinical laboratory professional to foster trans-sector collaboration in this regard. |
| Databáze: | OpenAIRE |
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