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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - Castor EDC (Castor EDC: Unlocking the Potential of Data in Biomedical Research)

Teaser

Summary

A large part of the data collected during the biomedical research is wasted, because there is no affordable and easy to- use Electronic Data Capture (EDC) tool for clinical trials. As a result, 85% of the research investment in the biomedical research domain â€“ equating to $200 billion â€“ 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. 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.

With regards to objective 1 TRL-9 has been achieved since the platform has been used successfully in medical device and biotech projects, demonstrating the robustness of the platform beyond academia. Furthermore, the groundwork for this has been created with our well-developed API (https://data.castoredc.com/api). No marketplace suppliers have yet been integrated yet, but we are in talks with several parties to develop this. Regarding objective 2, we are well on our way to becoming a EU market leader, with our 3,500 studies across 50+ countries and 30,000 researchers using the platform.

Work performed

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 coming year. Also test pilots are currently ongoing at several university medical centers in the Netherlands and abroad.

We made major steps in the development of the Castor EDC base platform. The new Interface has been designed and many advanced features, for example the automation engine, field encryption and advanced monitoring, were built. The platform is now ready to be used by medical device, biotech and pharmaceutical companies on a large scale. The integrations with EHR systems were advanced further.

We have made great headway in deploying more functionality through our API, a key requirement for sharing datasets globally. The API work combines much of the groundwork being done underneath, such as the standardization of the electronic Case Report Form by providing timely recommendations to researchers. With support for Resource Description Framework (RDF) and better metadata support Castor EDC is ready to serve as a FAIR Data Point. For this reason we have also started the application with the EOSC Hub. Weâ€™re also looking into other data sharing platforms and have talked with scientific publishers to explore other publishing and sharing possibilities.

Specific dissemination channels and modalities are used to spread our newly developed solutions to the most relevant market segments in academic research. One of those channels is conferences. We attended several conferences during the project, those with the largest impact were:
- Open Science Conference - Berlin, DE
- The Alzheimerâ€™s Association International Conference - Chicago, US
- American Heart Association Scientific Sessions - Chicago, US

Final results

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 â€“ at the same time â€“ 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 â€˜de factoâ€™ 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.

Large academic medical centers are selecting Castor because of it\'s promise to generate reusable data sets by standardizing data at the source in according to the FAIR principle and making it available to the Open Science platforms. This coupled with the EMR system integration (HL7 FHIR) and more and more advanced core platform capabilities (dashboarding, automation engine, etc) make it the only commercial EDC for mass deployment at academic sites.

Key success metrics include:
- 3,500 running studies
- 30,000 researchers
- Usage in 50+ countries