CA16113 - CliniMARK: ‘good biomarker practice’ to increase the number of clinically validated biomarkers. (CliniMARK)

Thousands of circulating proteins have been shown to be hallmarks of emerging disease, response to treatment, or a patients’ prognosis. The identification of these small molecule biomarkers holds a great promise for significant improvement of personalized medicine based on simple blood tests. For instance, diagnosis and prognosis with biomarkers (e.g.  carcinoembryonic antigen (CEA)) has significantly improved patient survival and decreased healthcare costs in colorectal cancer patients. Unfortunately, despite significant investments to increase the number of biomarker studies, only ~150 out of thousands of identified biomarkers have currently been implemented in clinical practice. This is mainly caused by the time-consuming process of reliably detecting biomarkers, the irreproducibility of studies that determine a biomarkers’ clinical value, and by a mismatch in studies that are performed by academia and what is required for regulatory and market approval. To increase the number of clinically validated biomarkers, rather than further increasing the number of biomarker discovery studies, CliniMARK will improve the quality and reproducibility of studies and establish a coherent biomarker development pipeline from discovery to market introduction.

CliniMARK aims to achieve said goal by creating a Best Biomarker Practice (BBP) community, which will provide guidance to:

1. Classify biomarkers according to their characteristics, anticipated clinical use, and their phase of development,
2. Select and validate appropriate research-grade biomarker detection tests,
3. Select appropriately designed studies and biological samples to reliably and reproducibly validate biomarkers clinically, and
4. Select and report on appropriate clinical data storage, biomarker data storage, data analysis protocols, privacy concerns, ethical issues, and statistical analysis methods.