Data sharing in clinical research can be justified on scientific, economic and ethical grounds: it can help to ensure more accurate science, reduce duplication and allow better use of funding as well as maximise the impact of trial participants. ECRIN, a signatory of the Manifesto for EU COVID-19 Research, continues to develop resources to aid clinical researchers in their search for treatments and vaccines for COVID-19. An amendment to the European Union’s Horizon 2020 funded EOSC-Life (GA 824087) has been approved to develop a repository for the hosting and sharing of Individual Participant Data (IPD) from COVID-19 clinical trials.
During a pandemic crisis, there is a particular need for timely and accurate collection, reporting and sharing of data within and between research communities, public health practitioners, clinicians and policymakers. Whenever possible, data should be hosted within trustworthy data repositories that have been certified, are subject to rigorous governance, and committed to the longer-term preservation of their data holdings. At present, there is no fully GDPR compliant, European repository dedicated to IPD derived from clinical research on COVID-19.
The IPD repository will be part of the European COVID-19 data portal, with ECRIN supporting the interface with the clinical research community, and with the technical partnership of the University of Oslo providing a secure environment and data sharing services. Discussions with stakeholders (e.g. scientific organisations, funders, publishers, policy makers, research infrastructures, standardisation bodies, COVID-19 initiatives, clinical trial investigators, patient associations, legal, ethical and technical experts) will drive the development and identify the most appropriate design and procedural options in the context of the GDPR and other relevant regulations as well as the best long term business model. The goal is to deliver a pilot COVID-19 repository as early as possible. The anticipated launch for a beta version is spring 2021. This is feasible because of the intensive preparatory work already done within the H2020 CORBEL project (GA 654248) and other projects by ECRIN and EOSC-Life partners.
With work underway since March of this year, a strategic plan for the development of a COVID-19 repository has been made available. This concept document for the design, development, implementation and use of a repository for IPD from COVID-19 clinical trials covers a range of aspects related to its creation and operation. These include legal challenges, functional specifications, quality assurance, implementation plan, sustainability and governance, evaluation of routine use, outreach, partnerships and scalability.
The next step for the COVID-19 IPD repository will be a series of stakeholder workshops planned in the coming months.
Canham S., Ohmann C., Thomassen G., Matei M., Demotes J., Panagiotopoulou M. (2020). EOSC-Life Strategic plan for the development of a COVID-19 repository including specification of technical requirements, policies and procedures. Zenodo.