An international consortium aiming to ensure that the clinical research community is better prepared for the next influenza pandemic or other rapidly emerging public health threat is launched today by leading funders of medical research from across the globe.
The International Severe Acute Respiratory Infection Consortium (ISARIC) is a global collaboration of more than 20 hospital-based clinical research networks. It aims to ensure clinical researchers have in place the necessary open access protocols and data-sharing processes - and have considered the ethical issues - that will allow them to respond to rapidly emerging diseases with epidemic or pandemic potential, such as the recent pandemic H1N1 influenza and SARS outbreaks (and, potentially, other rapidly emerging public health threats).
Its initial focus will be on clinical research in hospitalised patients to understand the causes of severe acute respiratory diseases, discover how these illnesses develop and progress in patients, and identify the best ways to treat the patients and prevent transmission. The studies will be undertaken both in the inter-pandemic period and in response to emergent threats.
The ambition of the Consortium is not only to undertake high-quality clinical research on a global scale but also to change the way such research is conducted in the settings of epidemics. It will also provide training, capacity strengthening and public engagement.
The Consortium is being launched by the Wellcome Trust and the UK Medical Research Council, the Bill & Melinda Gates Foundation, Inserm, Li Ka Shing Oxford Global Health Programme and the Singapore Ministry of Health. The announcement was made yesterday at the annual meeting of the American Society for Tropical Medicine and Hygiene.
Professor Jeremy Farrar, Director of the Wellcome Trust Vietnam Research Programme and Oxford University Clinical Research Unit Hospital for Tropical Diseases in Vietnam, will be the initial Chair of the Consortium.
"Clinical research will form a crucial element in the response to new epidemics and pandemics, and it is essential that we are prepared," says Professor Farrar. "The processes needed to initiate clinical studies and share data and samples effectively can take time to establish, but the faster we can react and the more trust we have built before the outbreak, the more effective will be our response and the more lives we can potentially save.
"By bringing together the many existing clinical research networks around the globe, by pooling the expertise across many countries, we can lay down the groundwork so that we are better prepared as a clinical community."
Outbreaks are often considered only in the context of influenza pandemics, but significant outbreaks are occurring regularly and with increasing frequency around the globe. They include outbreaks of dengue, nipah, viral haemorrhagic fevers, artemisinin-resistant malaria and many others.
The response of the clinical research community has been slow in almost all of these cases, argues Professor Farrar: "Many of the research communities involved in such outbreaks - for example, the public health, epidemiology, modelling and virology communities - have improved their response and connectivity considerably since the SARS epidemic, but the clinical research community has been very slow to respond to these new and emerging threats. The ISARIC network and its global partners hope to help address this."
"The local and global clinical response to epidemics remains too slow," said Professor Zhancheng Gao, Chief of the Department of Respiratory and Critical Care Medicine at Peking University People's Hospital, one of the founding investigators in the Consortium.
"For a novel emerging or re-emerging infectious disease, we have failed to learn as much as we could through clinical research during the early phase of these outbreaks. I am delighted to be a partner in the ISARIC Consortium and believe we can work together to change our approach to clinical research. ISARIC with its global partners and a focus on clinical research could help make a real difference to our ability to respond to epidemics and save patients' lives."
The ISARIC will develop and implement standardised protocols, metrics and data-sharing processes and will operate with pre-approved, open-access protocols that can be rapidly implemented in response to novel threats. This will ensure that researchers from high- and low-income countries are able to work to or adapt the same protocols and share data sets that are compatible. Its focus will initially be on respiratory infections, but it is hoped that this will extend to other areas in the future.
More than 20 networks are already signed up to ISARIC, spanning all six populated continents. This will enable rapid recruitment of patients across a range of income settings on a scale that is only possible with such a global collaboration. ISARIC is also working very closely with the InFACT Network, a newly formed network of 17 investigator-led intensive care research groups from countries around the world.
The networks will develop Consortium-wide projects in the inter-pandemic period. These projects will be supported via separate applications for funding through existing competitive mechanisms at funding agencies.
Initial potential projects include large-scale randomised control trials of therapeutic interventions in respiratory infections, a randomised control trial of drugs to modulate the immune response to severe influenza, studies of pharmacology and host and pathogen genetic factors involved in pathogenesis, and the ethical considerations of clinical research in the context of rapidly emerging health problems.