Guidelines for the use of biomarkers: Principles, processes and practical considerations

Abstract

With the growing availability of new health care technologies and rapidly emerging biomarker discoveries, clinicians need advice on the clinical validity and utility of new tests and whether they improve clinical, patient-centred, organizational or economic outcomes. High quality clinical practice guidelines (CPGs), based on well-designed and conducted test evaluation studies, are tools for translating research into practice and in promoting a value-and evidence-based approach for clinical utilization and reimbursement of new biomarkers. Such study protocols should be appropriate for the questions addressed at each stage of biomarker development: 1/ Basic research into the association of disease with the new biomarker; 2/ Modelling the potential use of the new biomarker in clinical practice; Studies on the 3/ analytic validity; 4/ clinical validity (effi cacy); 5/ clinical utility (effectiveness); and 6/ clinical impact (effi ciency) of testing. Irrespective of the facts that CPGs potentially infl uence important clinical decisions and thus patient outcomes, current approaches to CPG development often do not follow the rigorous processes of scientifi c publications. Guidelines should be outcome oriented; reliable and free from any forms of bias; based on high quality research or on formal consensus when evidence is confl icting or lacking; multidisciplinary; fl exible and applicable to various clinical circumstances and patient preferences; clear; costeffective; appropriately disseminated and implemented; amenable to measurement of their impact in practice; and regularly reviewed and updated. Therefore until guideline-making and reporting standards are improved, all CPGs should be carefully scrutinized for methodological and content validity before being adopted, adapted and used in clinical practice.

Methodical and pre-analytical characteristics of a multiplex cancer biomarker immunoassay

“…Currently used tumor markers are mainly tested with single parameter assays. Not least due to the great potential of differently composed assays or marker panels, respectively, this field requires further research in order to assess assay quality, increase comparability of multiplex assays, and to encourage consistent guidelines which as of yet are non-existent [3,9,15] . As already shown by other research groups marker combination has the potential to greatly improve the quality of early diagnosis and other therapeutically relevant applications [12,16,17] .…”

What is a Biomarker? From its Discovery to Clinical Application

“…Finally, the development of guidelines for biomarker application is very important, based on well de fined and properly conducted assessments of biomarker determination (35), providing the means by which research is translated into practice and allowing evidence based on facts to promote the clinical application of new biomarkers.…”

Society Spotlight: The European Federation of Clinical Chemistry and Laboratory Medicine

“…The group is preparing a scoping paper on biomarker evaluation and prepares an evidence based framework and supporting tools for testing the clinical effectiveness of diagnostic biomarkers for different applications. Some elements of the work have been presented at the Bergmeyer Conference in March 2010 and published in the conference proceedings [12]. The WG will present a session on test Evaluation at the Worldlab/Euromedlab Congress in 2011 in Berlin.…”