From Biomarker to Medical Test

摘要

The venue on the Adriatic provided a stimulating atmosphere in which to exchange ideas and develop new strategies for the evaluation of medical tests. In this time of austerity, justification of costs associated with the introduction of new laboratory tests should ideally be based on demonstration of proportional benefits to patients. New laboratory tests are often released to market with limited supporting evidence regarding their value or impact in clinical practice. Test evaluation should be performed with informed and carefully devised study design, yet evidence-based methodology is often lacking in the scientific literature, and when available is often poorly understood. As a consequence, inadequately designed evaluation studies may lead to erroneous clinical decision making that threatens patient safety. The Science Committee of the EFLM has established the test evaluation working group with the aim of developing a framework of guidance for the appropriate evaluation of new laboratory tests. They aim to develop practical tools to support the design and conduct of test evaluation studies and to aid training and education.