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Suffering from severe asthma generally implies experiencing extremely debilitating and risky events, like frequent severe exacerbations, emergency visits, and hospitalizations, all resulting in a sensible reduction of the quality of life. Also, in the past, patients were dependent on the use of oral glucocorticoids, which put them at increased risk for serious and often life-threatening adverse events. Recently, new biologics for severe asthma have become available, which have benefitted many but not all patients. Observational real world data can be key to answer questions about the natural history, burden and costs of this disease and its mechanisms, identification of different phenotypes and prediction of therapy response.

SHARP is a Clinical Research Collaboration (CRC) sponsored by the European Respiratory Society (ERS) and unrestricted grants from 5 pharmaceutical companies (Sanofi, TEVA, Novartis, GSK, Chiesi). It aims to facilitate access to severe asthma specialists for all severe asthma patients and understanding of the heterogeneity in mechanisms of severe asthma by researches and clinical personnel. Among other initiatives, it includes the establishment of a federated data analysis platform for individual national severe asthma registries across Europe to provide a comprehensive description of patient characteristics, phenotypes, treatment strategies, treatment responses to support patient care and enable international collaboration within a distributed research network. This aim entails an extensive work on every single data source, in order to bring every internal codification and non-standard expression of the available clinical information to the essential common denominator of standardized, interoperable data.

This is where Biomeris is involved, in the management of the process of data harmonization of each national data source to the OMOP CDM. This entails close cooperation with clinical and domain experts, to bring forth the mapping and the subsequent translation of data in the desired format.

CAPABLE (CAncer PAtients Better Life Experience) is a Horizon2020-funded project aimed at exploiting Artificial Intelligence (AI) and Big Data potentialities for cancer care. Predictive models defined leveraging multi-source retrospective and prospective data will be integrated with existing clinical practice guidelines and made available to oncologists. CAPABLE’s mobile coaching system for patients will allow identifying unexpected needs and providing patient-specific decision support.

Data will move within the environment built within the scope of the project- data coming from patient-compiled surveys, data from wearable sensors, data from hospitals’ EHR systems etc. As usual, the main problem lies in the heterogeneity and non-guaranteed compatibility of the involved sources.

Biomeris’s role in the CAPABLE project involves the creation of the data platform to house all the information circulating in the system. This of course also implies the harmonization of all supported data towards a common model. To do this, resources like the FHIR standard and the OMOP CDM are leveraged as main tools to obtain the required result.

This way it is guaranteed that every piece of information exchanged within the CAPABLE system is compliant to the FAIR principles (Findability, Accessibility, Interoperability and Reusability), thus representing a valuable asset for research and clinical practice.

European Health Data & Evidence Network (EHDEN), an IMI 2 consortium with 22 partners which will operate in Europe for the coming five years, 2018 – 2024. EHDEN is part of IMI’s Big Data for Better Outcomes (BD4BO) programme.

About IMI – FLUCOP

The goal of EHDEN is to make the large-scale analysis of health data in Europe a reality. The project aims to do this by building a federated data network of allowing access to the data of 100 million EU citizens standardised to a common data model. At the heart of the project will be a group of trained, certified small and medium-sized enterprises (SMEs) responsible for transforming the data owned by hospitals to the common data model. The data will remain under complete control of the original data owner, thereby ensuring ethical and local data privacy rules are respected.

BIOMERIS is the first italian SME certified by EHDEN for providing OMOP data harmonization: bit.ly/36yRGxI