Unmet clinical needs assessment for biomarker evaluation - a practical toolbox for Laboratory Medicine.
Speaker: Phillip Monaghan (UK)
Moderator: Christa Cobbaert (NL)
Date: 23rd April 2019 at 18:00 CET
The translation of promising biomarkers to clinical application is a critical opportunity for laboratory medicine; to provide information that enables clinicians to make better decisions about the care of their patients. The realisation of this goal is itself critically dependent on the appropriate evaluation of novel biomarkers for use in the clinical setting.
Inherent to this concept is consideration of the unmet clinical need that a laboratory test is aiming to address. However, as testing guides downstream clinical interventions to improve patient outcomes, the link between testing and outcomes is often indirect. As such, a full mapping of the clinical care pathway to define the purpose and role of the laboratory test and importantly, the clinical management decisions that the test will inform, thus enables the unmet clinical need to be addressed and furthermore complemented by the anticipated impact on patient outcomes.
The corollary from this approach is the early specification of analytical and clinical performance criteria to subsequently evaluation studies in a cyclical manner, keeping the clinical care pathway and outcomes as the key drivers in the process. In doing so, biomarker development can be aligned to address existing gaps in clinical care and mitigate research waste and inappropriate utilisation of laboratory tests where clinical benefit is uncertain or at worst potentially harmful.
There is a major opportunity here for laboratory professionals to play a key role in the development and implementation of clinical care pathways for new and existing laboratory tests. Stakeholder involvement; working together to overcome the conventional silos across disciplines is paramount to drive the adoption of innovative tests with robust implementation planning, so that test results are available and acted upon in an appropriate and timely manner, with a strong link to clinical intervention and outcomes. To realise the value of laboratory medicine in this context, the EFLM Working Group for Test Evaluation (WG-TE) has developed a ‘practical toolbox’ providing a Test Evaluation Framework and Interactive Unmet Clinical Needs Checklist (hosted on the EFLM eLearning platform) to assist laboratories and other key stakeholders in clinical translational research, to undertake clinical needs assessment and clinical care pathway development.
About the speaker
Dr Phillip Monaghan - Consultant Clinical Scientist The Christie Pathology Partnership
After graduating from the University of Manchester Institute of Science and Technology (UMIST) in Biochemistry with Applied Molecular Biology, Phillip went on to complete his PhD in Enzymology at the University of Leicester. He subsequently commenced training in Clinical Biochemistry at Wirral University Teaching Hospital, Alder Hey Hospital and University Hospital of South Manchester. Phillip has been a Clinical Scientist at The Christie Hospital and more recently The Christie Pathology Partnership in Manchester, UK, for the past 8 years, obtaining Fellowship of the Royal College of Pathologists (FRCPath) in 2014. Phillip is a state registered Clinical Scientist with the Health and Care Professions Council (UK) and a European Specialist in Laboratory Medicine (EuSpLM). Phillip is Honorary Lecturer at the University of Manchester in the Faculty of Medical and Human Sciences, Institute of Inflammation and Repair, and regularly teach on the MSc Clinical Sciences programme. Phillip is a member of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Test Evaluation (WG-TE). He is a member of the UK NEQAS Steering Committee for Immunochemistry and is Associate Editor for the Annals of Clinical Biochemistry journal. Special interests include evidence-based medicine (test evaluation), biochemical endocrinology & neuroendocrinology and assay interference studies. Phillip was awarded the Silver Research Medal from the Royal College of Pathologists in 2012 for his work on serum cortisol measurement in Cushing’s disease. Phillip is Lead Healthcare Scientist for his Hospital. |