Subsequently, CliniMARK will define the requirements for analytical validation for the selected test for each biomarker (e.g. what sample material to use, and limits for variability, and reproducibility). Furthermore, the network will compile and use existing guidelines on biobanking for biobanks in COPD. CliniMARK will classify COPD biomarker classes according to their prospective use (e.g. diagnosis, companion diagnostic, prognosis) and evaluate optimal clinical validation study designs (e.g. sensitivity, specificity, clinical impact, economic impact). For each protein biomarker, a development plan for appropriate feasibility study designs will be developed. In addition, in parallel to the specific development plans for COPD biomarkers, a BBP will be designed, based on the thorough evaluation of available biomarker measurement techniques, clinical feasibility study design and existing guidelines. This process will result in two documents: First, a standardized development plan, (outlining intended use, analytical specificiations, and clinical feasibility study design) for selected COPD biomarkers to efficiently enter into phase 3.
And second, during development of the plan for specific biomarkers, all decisions and considerations for these decisions will be documented and integrated to develop a standardized BBP whitepaper on selection and analytical validation of research-grade detection techniques and clinical feasibility studies for biomarkers in general.