EHDEN’s COVID-19 Rapid Collaboration Call – Paving the way to generate real-world evidence and treatment insights

19 May, 2020, Brussels, Belgium:  Clinicians, scientists, governments and the public all want to know more about characterising patients with COVID-19, how best to manage their care, and if certain treatments are safe and effective. To help provide these answers, EHDEN announced a rolling COVID-19 Rapid Collaboration Call, which ran from 16 April – 14 May.

Upon conclusion of the Call, seventy-five applications were submitted from twenty countries across  Europe, forty-four of which came in the last two days of the Call. Of the initial applications, six have so far been accepted. These successful applications represent 255,000 COVID-19-tested patients, of whom more than 52,000 tested positive.

With the Call now closed, every effort is being made to expedite the processing of the remaining applications. Due to the particularly strong response rate seen at the end of the Call process, there will most certainly be a significant increase in the number of accepted applications and COVID-19 patient data. When this part of the process has been completed, harmonisation of data will begin immediately so that meaningful insights and evidence can be generated in the coming weeks and months that will help win the fight against COVID-19.

Why a Collaboration Call?

The world is still very much fighting the SARS-CoV- 2 pandemic, and in many countries, is still striving to deal with a growing number of COVID-19 patients. Data and derived insights and evidence are the lifeblood of pandemic decision-making, whether clinically for patient care, or for governments in making the right decisions in responding to SARS-CoV-2/COVID-19. Outside of a pandemic, as well as during this one, real-world health data is often fragmented, siloed in poorly interoperable systems and requires considerable curation to work with. The Collaboration Call was all about bridging these gaps.

On 26-29 March, the global Observational Health Data Science & Informatics (OHDSI) community, in collaboration with EHDEN, conducted a COVID-19 study-a-thon, with ongoing analysis to research the characterisation of COVID-19 patients and analogues such as influenza. It also evaluated the safety profiles and potential efficacy of several drugs proposed for repurposing in treating SARS-CoV-2/COVID-19. This served as proof of concept in how standardising data can facilitate fast analysis supporting evidence-based decision-making. Two manuscripts have already been submitted to journals, focusing on the safety profile of hydroxychloroquine (preprint), and the characterisation of COVID-19 patients versus prior influenza patients (preprint).

Following on from this, especially with regard to quickly supporting a collaborative, open science community such as OHDSI that is able to research the pandemic rapidly, EHDEN is providing financial and technical support to assist Data Partners with harmonising their representative and relevant (anonymised) COVID-19 clinical data to the OMOP common data model.

How it works

EHDEN had an Open Call for European Data Partners to apply through its portal via a short COVID-19 Call application template. A panel of acknowledged biomedical data experts is reviewing applications. Successful applicants will:

* Receive a sub-grant from EHDEN of up to €50,000 (from EHDEN’s overall €1M Harmonisation Fund for this specific Call) based on evaluation of data complexity, to support the process of data harmonisation to the OMOP common data model and allied tools

* Be able to engage with an EHDEN COVID-19 Taskforcemade up of technical experts with skills and experience to assist with remote harmonisation of data (under the current pandemic restrictions)

* Be invited to participate in COVID-19 research studiesto accelerate our understanding of how to combat this pandemic and improve patient outcomes, so the main criteria for inclusion in this Call is relevance and representativeness of COVID-19 data

Recognising that institutions holding COVID-19 data are giving priority to their clinical duties during the pandemic, the idea is that the overhead be minimal for them. EHDEN therefore created a taskforce of project partners, volunteers, and certified small- and medium-sized enterprises to manage and perform data harmonisation and all tooling so that the data sets can be analysed throughout Europe for the benefit of all.

To ensure safety of patient data, EHDEN operates as a federated network model where all patient-level data remains local and analytical tools are brought to data, with oversight by the Data Partner and local governance.

“We’re thrilled that this Collaboration Call enjoyed such a strong response rate, which clearly shows the collaborative spirit of the scientific community. When this data harmonisation process has been completed in the coming weeks and months, we’re confident it will facilitate research for meaningful insights and real-world evidence across Europe, and we are looking forward to working with our Data Partners on this,” said Associate Professor Peter Rijnbeek, EHDEN Coordinator. He added, “This will contribute to our knowledge and help improve management and treatment of COVID-19.”

Nigel Hughes, Scientific Director, Janssen, and EHDEN Project Leader echoed this, and stated, “This pandemic has been characterised by how much we don’t know, versus what we do. Decisions at a policy and clinical level have been impacted by insufficient or a lack of credible data. As the pandemic progresses globally over 2020, we need answers and an ability to do this collaboratively with speed for upcoming peaks, as well as to support clinicians, researchers and governments as we try to effectively prevent and treat COVID-19. We are grateful to all who applied and are looking forward to collaborating closely with successful applicant Data Partners”