Currently there are no widely accepted, overarching strategies to harmonize (i) heterogeneous health and disease data and (ii) data-driven in silico approaches for the interpretation of Big Data to enable personalized medicine. In addition, data governance concerning the collection, share, access, storage, use, and re-use of data needs to be further developed and broadly implemented. What is lacking are standardization documents issued through e.g. the European Committee for Standardization, CEN or the International Organization for Standardization, ISO and recommendations for innovative data governance concepts, such as harmonized Data Access Agreements. This would allow for the exploitation of Big Data to develop true medical benefits for an individual patient or stratified patient groups. These exploitations, however, need to be based on a clear framework regarding legal, ethical, policy issues and certification for data-driven in silico models in personalized medicine.
A central task of EU-STANDS4PM was thus to develop harmonized standards as well as recommendations and guidelines for predictive data-driven in silico methodologies applied in personalized medicine with a focus on the following central aspects:
(1) To develop universal standards as well as recommendations for in silico methodologies applied in personalized medicine approaches.
(2) To provide guidance on the legal, ethical and policy considerations arising from data integration for in silico modelling for personalized medicine.
(3) To implement a pilot for an innovative framework for progressive dissemination for data access, sharing, dissemination for future collaborative EU research.
Taken together the above-summarized objectives will have a major impact on:
Collaborative research – Applying universal standards in research practice will improve the quality, reproducibility and sustainability of pre-clinical and translational projects that aim at implementing computational models in clinical routine in the future, e.g. to identify and reconstruct disease-driving mechanisms or to integrate such models in decision support systems for individualized prevention and treatment strategies.
Funders – National funding bodies, as well as the EU-Commission, will have an additional level of quality assurance if the use of normative documents for specific topics in future calls will be made mandatory for applicants. Especially the use of ISO-based normative documents will ensure that public funds are being invested based on international, quality ensured standards for state of the art scientific practice.
