Periodic Reporting for period 2 - euCanSHare (An EU-Canada joint infrastructure for next-generation multi-Study Heart research)
Periodo di rendicontazione: 2020-06-01 al 2021-11-30
Despite continuous advances in diagnosis and treatment, cardiovascular diseases (CVDs) remain the main cause of mortality worldwide, accounting for about a third of annual deaths. Furthermore, they greatly reduce the quality of life of cardiovascular patients, who are estimated at a staggering figure of 85 million in Europe alone (CVD Statistics report 2017). CVDs also challenge the financial stability of modern healthcare systems and have a negative impact on economic growth. In this context, researchers are currently in great need of “big data” from population and patient cohorts to extract new knowledge on CVDs, to validate new biomarkers, and to develop new treatments. However, access to data remains a substantial barrier for researchers and innovators, especially in the new regulatory context of the GDPR (Nicholas, M. et al. Information Systems Frontiers, 2019).
For a long time, cardiovascular research had been conducted based on single cohorts such as the well-known Framingham Heart Study. However, single studies are limited to specific populations, geographical areas and even data types. Consequently, multi-cohort approaches have been proposed, both in Europe and in Canada to allow researchers to investigate heterogeneous determinants and biomarkers of CVD in more comprehensive samples, and to uncover new biomedical knowledge with increased sample size, geographical coverage, and data richness. However, these initiatives did not develop the much-needed IT infrastructures to enable the re-use of the data beyond the duration of the funded projects.
The main challenges are: (1) there are no catalogues to enable easy access to information on available data, their precise characteristics and potential for cardiovascular research studies; (2) access request mechanisms remain highly traditional, manual and lengthy, which greatly reduce the much-needed efficiency in data-driven biomedical research; (3) re-usability of the data for cardiovascular personalised medicine is often reduced when the funding is terminated; (4) there are major ethical and legal concerns that need to be addressed to enable responsible data sharing and analysis with a high level of data protection and security.
The main objective of euCanSHare is to build a multi-centre big data platform for cardiovascular research that addresses the challenges listed above. This user-friendly platform will provide a number of functionalities that will enable easy access to information on available data, that will facilitate the process of requesting and granting access to the data, as well as the process of building data analysis workflows to execute the research studies, while complying to the highest ethical and legal standards of data privacy and security.
For a long time, cardiovascular research had been conducted based on single cohorts such as the well-known Framingham Heart Study. However, single studies are limited to specific populations, geographical areas and even data types. Consequently, multi-cohort approaches have been proposed, both in Europe and in Canada to allow researchers to investigate heterogeneous determinants and biomarkers of CVD in more comprehensive samples, and to uncover new biomedical knowledge with increased sample size, geographical coverage, and data richness. However, these initiatives did not develop the much-needed IT infrastructures to enable the re-use of the data beyond the duration of the funded projects.
The main challenges are: (1) there are no catalogues to enable easy access to information on available data, their precise characteristics and potential for cardiovascular research studies; (2) access request mechanisms remain highly traditional, manual and lengthy, which greatly reduce the much-needed efficiency in data-driven biomedical research; (3) re-usability of the data for cardiovascular personalised medicine is often reduced when the funding is terminated; (4) there are major ethical and legal concerns that need to be addressed to enable responsible data sharing and analysis with a high level of data protection and security.
The main objective of euCanSHare is to build a multi-centre big data platform for cardiovascular research that addresses the challenges listed above. This user-friendly platform will provide a number of functionalities that will enable easy access to information on available data, that will facilitate the process of requesting and granting access to the data, as well as the process of building data analysis workflows to execute the research studies, while complying to the highest ethical and legal standards of data privacy and security.
During the second reporting period, the euCanSHare project has focused on the continuous development, validation and enhancement of the cardiovascular platform. The first version of the euCanSHare platform has been released to the scientific community and general public at M29. It now includes a fully configured data catalogue, including data from 34 project cohorts, 76 datasets, 26,296 variables and the necessary infrastructure for the inclusion of genomics and imaging data, as well as an initial set of analysis tools and the data access interfaces. The data analyser environment was extended by new tools to process cardiac imaging, omics and health data, such as the differential gene expression analysis, SNP extraction tools and data harmonisation tools like the DICOM to NIFTI converter. In parallel, a survey was initiated to monitor and test all integrated tools to identify areas of improvement and share the feedback with developers. In addition, several multi-centre collaborative use cases have been initiated to validate and enhance the capabilities of the euCanSHare platform. To optimise the harmonisation of the different use cases, existing guidelines were extended with new standards and methods by defining variables and their harmonisation potential. Furthermore, the interoperability of available cohorts was assessed and data sharing barriers analysed. The analysis has demonstrated that there is a general ethical and legal interoperability amongst the cohorts participating in the euCanSHare initiative, in that these cohorts can for the most part be used for compatible purposes of secondary use in the area of cardiovascular health research, with the potential for international sharing of such data. In this context, a euCanSHare workshop entitled “Incentives for Data Sharing” was held at the end of September 2020 and consensus recommendations from this workshop were published in Open Research Europe in November 2021.
euCanSHare will address the lack of IT infrastructures and advanced solutions for enhancing the re-use of data and their sustainability beyond the end of funded projects. The project will increase trust through state-of-the-art data protection solutions, while providing new incentives for new cohorts to join the platform beyond the lifetime of the project. euCanSHare will be the first multi-study project to integrate cardiovascular -omics, imaging and clinical data into a unified data infrastructure. This will address the current data fragmentation and offer new avenues for personalised medicine research in the field of cardiology. Furthermore, euCanSHare will promote responsible data sharing in the cardiovascular research field, guided by international principles and policy statements such as the “Framework for Responsible Data Sharing” developed by the Global Alliance for Genomics and Health (GA4GH). Cultural and ethical obstacles to data sharing will be studied through direct interactions with data owners and researchers, which will result in a set of recommendations to incentivise cohort owners to share more data, distributed to all major medical data platforms in Europe and Canada. The euCanSHare platform will also integrate novel solutions from the previously funded MyHealthMyData project, specifically the so-called blockchain as a secure and decentralised access-control manager for the data stored at the various repositories or individual local storage.
The euCanSHare platform is expected to impact cardiovascular research, such as for knowledge, biomarker or drug discovery. The platform will enhance the discoverability of relevant datasets for quantifying and validating new cardiovascular biomarkers (including -omics, imaging and circulating). By nature of this EU-Canada collaboration, euCanSHare also allows uniquely to investigate the impact of ethnicity, environment and genetics in the genesis, diagnosis and treatment potential of complex CVDs. The euCanSHare platform will also gather a new knowledge base for public health and policy making. For CVDs explored in euCanSHare, it will be possible to place their genesis in the context of the complex relationships of the combined effects of environment (region/country), lifestyle, genetics, and context (e.g. immigration) on the health of the respective populations. Ultimately, new data-driven innovations and health policies will lead to improved effectiveness and cost efficiency of prevention and treatment of the most prevalent CVDs, which will realise important benefits for patients, healthcare systems and societies.
The euCanSHare platform is expected to impact cardiovascular research, such as for knowledge, biomarker or drug discovery. The platform will enhance the discoverability of relevant datasets for quantifying and validating new cardiovascular biomarkers (including -omics, imaging and circulating). By nature of this EU-Canada collaboration, euCanSHare also allows uniquely to investigate the impact of ethnicity, environment and genetics in the genesis, diagnosis and treatment potential of complex CVDs. The euCanSHare platform will also gather a new knowledge base for public health and policy making. For CVDs explored in euCanSHare, it will be possible to place their genesis in the context of the complex relationships of the combined effects of environment (region/country), lifestyle, genetics, and context (e.g. immigration) on the health of the respective populations. Ultimately, new data-driven innovations and health policies will lead to improved effectiveness and cost efficiency of prevention and treatment of the most prevalent CVDs, which will realise important benefits for patients, healthcare systems and societies.