Procedural guidance for the systematic evaluation of biomarker tests

Biomarker
Research area: HTA-methods & steering instruments

Project leaders: Ingrid Zechmeister-Koss

and Ingrid Zechmeister-Koss
Duration:  April 2014 – September 2014
Publication: Decision Support Document No. 77: https://eprints.aihta.at/1041/

Language: English

Personalised Medicine seeks to improve stratification and timing of health care by utilising biological information and biomarkers on the level of molecular disease pathways, genetics, proteomics as well as metabolomics. The usefulness of a biomarker test requires the demonstration of its diagnostic accuracy together with the demonstration of its clinical utility. The methodology for evidence-based evaluation of biomarkers is not yet fully established. In a recent LBI-HTA project current methodological approaches of leading HTA institutes were reviewed and synthesised into a procedural guidance.
 

Common challenges in the evaluation of biomarkers and medical tests are the assessment of multiple steps in a clinical path (test and treatment), methodological challenges in systematic reviews of diagnostic accuracy and prognostic tests, the lack of direct evidence from randomised clinical trials/RCTs and the complex assessment of the applicability of the test and treatment strategy.

The procedural guidance is meant to support -  step by step - with specific challenges in biomarker evaluation: How to identify the test and treatment strategy in which the test will be used, how to classify the information provided by the different study designs used in biomarker studies and to assess the validity of these studies and how to approach the lack of direct evidence from RCTs. Useful further reading and references to existing method manuals is provided for each section.