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Castor EDC Report Summary

Project ID: 767814

Periodic Reporting for period 1 - Castor EDC (Castor EDC: Unlocking the Potential of Data in Biomedical Research)

Reporting period: 2017-04-01 to 2018-03-31

Summary of the context and overall objectives of the project

A large part of the data collected during the biomedical research is wasted, because there is no affordable and easyto- use Electronic Data Capture (EDC) tool for clinical trials. As a result, 85% of the research investment in the biomedical research domain – equating to $200 billion – is dissipated. Castor is a disruptive EDC that solves this problem. It has been successfully commercialized to 5,000 users in the Netherlands, especially in the academic sector. In terms of price and functionalities, Castor EDC is tailored to the needs SMEs performing medical research and academic institutions; these segments are neglected by the existing commercial EDC platforms, which mainly target the needs of pharmaceutical corporations. This market is enormous (over €1.7B globally) and growing quickly due to the recent EU regulations on sensitive data protection. Castor EDC is also the first EDC complying with the FAIR guidelines for data collection, which will become the standard de facto within a couple of years. Thanks to these characteristics, data sets can now be easily shared across researchers and reused, thus unlocking the potential of data of biomedical studies. This will help to overcome the current fragmentation of the European databases that has led to lost opportunities when making sense of big data in health research. The Castor EDC innovation project has two main objectives. First, upgrading the existing tool to technology readiness level 9 by enhancing the system with advanced functionalities of the Electronic Data Capture tool and integrate it with 1) a platform that facilitates researchers in sharing and re-using their datasets and, 2) a marketplace where 3rd party developers can offer additional services to work on those datasets. Second, carry out the planned exploitation activities to establish Castor EDC as a EU-28 market leader in the market within 3 years from the end of the project.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The proposed technical upgrades of the Castor EDC core platform with numerous new functionalities is largely on track with several sub-tasks ongoing (i.e. Automation Engine, Risk Based Monitoring, Splitting Testing and Production environments, Advanced Monitoring, Logistical Support Module), or even completed (i.e. Library management). Also large progress is made in the refinement of the new Castor EDC user interface. Furthermore, we are progressing swiftly on expanding our technology to allow researchers to generate Finable, Accessible, Interoperable and Reusable data. The BioPortal Application Programming Interface (API) client developed will also provide the foundation for the coding engine, as well as for the marketplace and the R-integration, which will allow transformations of datasets in STATA and SAS formats. The development of the Smart Collaborative Research Platform and Castor Marketplace will be initiated in the coning year. Also test pilots are currently ongoing at several university medical centers in the Netherlands and abroad.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Improving the quality of biomedical data is of paramount importance for the EU.There is a wide acknowledgement within Europe that the lack of data standardization and reuse will hinder biomedical research in its path towards the exploitation of big data in health. Castor EDC will bring substantial value to the European Open Science Cloud. This initiative can only thrive when the threshold of participation is set low, while – at the same time – the security and privacy regulations as laid down in the new EU data protection regulation are respected. Castor EDC will fulfill both conditions. Castor EDC will give an important contribution to the FAIR data initiative, according to which data should be Findable, Accessible, Interoperable, and Reusable. As the first Electronic Data Capture platform using FAIR at the source, Castor EDC will become ‘de facto’ the most suitable environment where biomedical data can be treated according to FAIR principles. Our work will then give an impulse to the whole initiative and oblige other vendors to adopt it.

Castor EDC will have an impact that goes beyond the commercial success and contribute to strategic initiatives defined by the European Commission. In particular, our product will give a huge impulse to the European Open Science Cloud, by allowing the biomedical researcher to share and reuse standardized data.The lack of data sharing and reuse is now a real concern: a recent study shows that 61% of the biomedical researchers have never uploaded data to a repository, and since there may be a response bias in this figure, the number is probably even higher. The practical applications that such a massive amount of open data could unlock are bounded only by the imagination of the researchers. The existence of easily accessible and widely collected standardized EMR data may have a major impact over the overall healthcare system, whose complexity and costs will continue to increase.

In this respect, the 2016 reform of EU data protection act facilitates the reuse of data for research, even where the data were collected for another purpose. The Regulation clearly allows research to take place with sensitive personal data − such as health data − without consent, provided that certain conditions are met: therefore, the connection with Electronic Medical Records (EMR) systems– which is unique to Castor EDC – becomes even more relevant. And last but not least, Personal data can be stored for longer periods of time for research than other purposes.

The functionalities envisioned by TRL9 version of Castor EDC have no comparison in the existing commercial offer of Electronic Data Capture applications. Castor EDC is radically new in at least three aspects: (1) It aims at generating reusable data sets by standardizing data at the source in according to the FAIR principle and making
it available to the Open Science platforms; (2) It embeds features unavailable in any other EDC application, such as the EMR system integration (HL7 FHIR); (3) It creates a marketplace where external parties can add their own services on the top of Castor EDC, offering the possibility to enhance the commercial offer of services related to biomedical research data. The potential scenarios made possible by Castor EDC are potentially disruptive.

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