Procedural guidance for the systematic evaluation of biomarker tests
Project leaders: Ingrid Zechmeister-Koss
and Ingrid Zechmeister-Koss
Duration: April 2014 – September 2014
Publication: Decision Support Document No. 77: http://eprints.hta.lbg.ac.at/1041/
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.