COVID-19 has exposed our vulnerability to pandemic infections and shown what works, and what doesn’t, in detection, characterisation and response. It has tested the effectiveness of ISARIC’s operating model: a global, open-source, collaborative approach set up 10 years ago to prevent illness and deaths from infectious disease outbreaks.
The vital elements of a successful response to outbreaks is preparedness: ISARIC has built research tools and a data management platform with an established network of researchers from all over the world. For 10 years ISARIC has been championing the use of pre-prepared research tools, global collaboration, and research-ready clinical networks. In 2012 ISARIC launched the Clinical Characterisation Protocol (CCP) in collaboration with the WHO.
To make clinical and biological observations within a timeframe that can benefit patient care with COVID-19 and inform policy, coordination of global research must match the speed of spread. ISARICs pre-prepared research tools, global collaboration and research-readiness accomplish this. This meant ISARIC was able to implement these tools rapidly at the start of the COVID-19 pandemic.
In January 2020, ISARIC launched its COVID-19 Clinical Characterisation Protocol (CCP) and Case Report Forms (CRF) as well as a free data management platform for researchers to upload their clinical data, globally.
“I remember I kept refreshing the database page, waiting for the first patient records to come through”, said James Lee, Senior Clinical Trials Manager at ISARIC. The ISARIC COVID-19 CCP database was open and publicly accessible from January 23rd, 2020, when less than a thousand COVID-19 cases had been reported globally, and the 13 February 2020, the first patient record was successfully uploaded onto the platform. Barely a month after, the platform reached 10K records.
The effort to gather more evidence continued, and the CRF was translated into five different languages to facilitate global access to these tools. A new RAPID CRF version was also launched, focused on selected information.
Now, 18 months into the pandemic, with more than half-a-million records, the ISARIC clinical data platform has grown to become the largest international individual patient dataset of COVID-19 hospitalised cases. It is a model of global peer-to-peer collaboration, with contributions by 788 sites in 62 countries. Cases are approximately 50:50 from high-income and low- and middle-income countries. This work is in close partnership with IDDO (the Infectious Diseases Data Observatory), that curate and host the data platform.
By supporting research groups with tools that are standardised but flexible, ISARIC has delivered an adaptive, observational infrastructure that enables the generation, collection, analysis, and dissemination of important knowledge during a pandemic. More than 50 reports and manuscripts have been published to date and many more are in progress or under peer-review. Results are published under collective authorship involving hundreds of authors. Datasets can also be accessed by non-ISARIC researchers by applying through a data access committee managed by IDDO (Infectous Diseases Data Observatory).
“This is what we prepared for, and we successfully facilitated global collaboration and furthered the knowledge on COVID-19” said Peter Horby, Executive Director of ISARIC and Professor of emerging infectious diseases at the University of Oxford.
The ISARIC global collaboration adapts to the evolving nature of the COVID-19 pandemic, and is now gathering evidence on vaccine breakthrough cases, virus variants and Long COVID.
ISARIC is a global federation of clinical research networks, providing a proficient, coordinated, and agile research response to outbreak-prone infectious diseases. ISARIC’s mission is to generate and disseminate clinical research evidence for outbreak-prone infectious diseases, whenever and wherever they occur.
This research was funded by the Wellcome Trust, the UK Department for International Development, and the Bill & Melinda Gates Foundation.