COST Clinimark Training School

The COST Clinimark Training Workshop is taking place from 23-27 September 2019 at the Spetses Hotel, Greece! 

The quest for novel biomarkers is a popular research activity with high productivity. Thousands of studies are published claiming the discovery of biomarkers suitable for improving disease management. The stark reality though indicates that very few potential biomarkers are approved for clinical use. The application of omics approaches (Genomics, Transcriptomics, Proteomics, Metabolomics, etc.) in biomarker discovery has contributed significantly in increasing the number of publications reporting initial findings that are not validated. Major issues associated with this dire situation are the difficulty in analytical validation of robust biomarker assays, flawed study design, and the inability to exploit the full potential of high-throughput omics approaches. Thus, there is a waste of research resources without tangible benefits to society. Moreover, there are many unmet clinical needs that are not currently addressed by the available biomarkers in diseases of high prevalence and of high financial and social cost such as cancer, cardiovascular disease, chronic kidney disease, and chronic obstructive pulmonary disease. This situation is partly due to a lack of education resources dedicated to omics studies in biomarker research.

Teaching Objectives

The unique feature of the proposed workshop is that it will expose the problems associated with omics biomarker studies and train a new generation of scientists able to fix the flawed biomarker discovery and implementation paradigm. In order to achieve this ambitious goal the following specific teaching objectives are set so that students can:

1. obtain a global view of omics approaches and the biomarker life cycle from discovery to clinical implementation
2. acquire skills relevant to biomarker data analysis (analytical assay validation, clinical performance)
3. develop critical thinking by thorough evaluation of published biomarker studies, and improve writing and presentation skills

The following topics be covered during the workshop:

A) Introduction to the different biomarker types (diagnostic, prognostic, etc.)

B) Introduction to the different omics approaches and their application in the context of biomarker research

C) Emphasis on the importance of defining the biomarker context of use in the clinical setting before initiating a research protocol on biomarker discovery and validation

D) Presentation of good biomarker practice guidelines on:

1. study design (number and type of samples, proper statistical analysis, reporting of all findings, etc.)
2. analytical validation of assays (reproducibility, LOD, linearity, etc.)
3. clinical performance (sensitivity, specificity, etc.), validation in an independent large set of samples (ideally multi-center study) by different researchers (external independent validation)
4. comparison of the performance of the new biomarker with biomarkers already used in clinical practice (umbrella reviews)
5. tools for assessing if biomarkers are effective in improving concrete patient clinical outcomes (randomized trials, etc.)
6. implementation in sub-optimal conditions and different populations.