title: Biomarker development targeting unmet clinical needs.
abstract: 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.
authors.affiliation: Department of Clinical Biochemistry, The Christie Pathology Partnership, The Christie NHS Foundation Trust, Manchester, UK. Electronic address: phillip.monaghan@nhs.net.
authors.forename: Phillip J
authors.initials: PJ
authors.lastname: Monaghan
authors.affiliation: School of Medicine, University of Notre Dame, Australia; National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Australia.
authors.forename: Sarah J
authors.initials: SJ
authors.lastname: Lord
authors.affiliation: ARC Consulting, Perth, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: St John
authors.affiliation: The Norwegian Quality Improvement of Primary Care Laboratories (NOKLUS), Haraldsplass Deaconess Hospital, Bergen, Norway; Department of Public Health and Primary Health Care, University of Bergen, Norway; Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway.
authors.forename: Sverre
authors.initials: S
authors.lastname: Sandberg
authors.affiliation: Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, The Netherlands.
authors.forename: Christa M
authors.initials: CM
authors.lastname: Cobbaert
authors.affiliation: Abbott Diagnostics, Wiesbaden, Germany.
authors.forename: Lieselotte
authors.initials: L
authors.lastname: Lennartz
authors.affiliation: Medical and Scientific Affairs, Roche Diagnostics International Ltd., Rotkreuz, Switzerland.
authors.forename: Wilma D J
authors.initials: WD
authors.lastname: Verhagen-Kamerbeek
authors.affiliation: Medical and Scientific Affairs, Roche Diagnostics GmbH, Penzberg, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Ebert
authors.affiliation: Department of Clinical Epidemiology, Biostatistics & Bioinformatics, Academic Medical Center, University of Amsterdam, The Netherlands.
authors.forename: Patrick M M
authors.initials: PM
authors.lastname: Bossuyt
authors.affiliation: SEALS Department of Clinical Chemistry and Endocrinology, Prince of Wales Hospital and School of Medical Sciences, University of New South Wales, Australia; Screening and Test Evaluation Program, School of Public Health, University of Sydney, Australia.
authors.forename: Andrea R
authors.initials: AR
authors.lastname: Horvath
mesh_terms: D015415:Biomarkers; D057189:Checklist; D000066491:Clinical Decision-Making; D032921:Consensus; D006801:Humans; D017410:Practice Guidelines as Topic / Q000592:standards*
chemical_list: D015415:Biomarkers
keywords: Biomarker; Checklist; Clinical pathway; Medical tests; Unmet needs