Project deliverables

At the end of the project, APPROACH aims to provide the following tools, methods and definitions that can be used to optimize future clinical trials for OA:

  • An integrated bioinformatics platform that functions as a repository of clinical data, biomarker data and images from a broad spectrum of OA patients.

  • Bioinformatics in the longitudinal APPROACH cohort enables definition of specific outcome measures that best differentiate progressors from non-progressors for each phenotypical subset and will finally position each patient on a phenotype-dependent OA progression scale. This new definition, encapsulating variation of disease phenotypes will form the basis of new guidelines for OA patient assessment directed at the development of specific phenotype dependent trial-protocols to validate new DMOADs. 

  • Clinically applicable next generation markers based on imaging, locomotion and biochemical/omics methods.

  • Validation and qualification of diagnostics methods and criteria that are well described in guidelines and used in prediction models to support new DMOAD trials, with medication that is specifically targeting phenotypically different OA patients.

  • Finally, APPROACH will deliver a comprehensive consensus report describing how to stratify OA patients in phenotypes that can be targeted with putative DMOAD therapies in subset dependent trial protocols. This will support the regulatory bodies, such as EMA (and FDA), to direct and apply guidelines for the use of defined, validated and specific endpoints.