In 2009 several UK research studies into clinical and public health responses to the influenza A H1N1 pandemic were rapidly activated but the time required to call for research proposals, assess, fund and set up the projects meant that some studies were published too late to have a substantial effect on clinical care. The authors of a personal view in The Lancet outline a model to address such inherent delays: the National Institute of Health Research (NIHR) funded pandemic influenza preparedness portfolio.
The suite of eight studies address different aspects of healthcare for influenza including surveillance, primary prevention (vaccination), triage and clinical management. The studies were set up and are on standby in a maintenance-only state awaiting activation should a pandemic be declared. One of the eight, the UK Obstetric Surveillance System (UKOSS) influenza in pregnancy study, is co-ordinated by the National Perinatal Epidemiology Unit and will collect information on pregnant and post-partum women admitted to hospital with confirmed influenza infection.
While we don’t know when or whether an influenza epidemic will happen, other emerging infective challenges will continue to occur. Hibernated studies can act as a model for research in a future pandemic or emerging infection, for example UKOSS was used to study Zika virus exposure during pregnancy when concerns were recently raised about the link between Zika infection and birth defects.
Keeping studies in standby mode awaiting a pandemic, however, raises a number of issues including the need to maintain stakeholders’ engagement and to resist attempts to close hibernated studies. Evolution of the IT landscape can also affect the maintenance of dormant studies, for example, the UKOSS research platform switched from a paper-based reporting system to an electronic system during the hibernation period.
Other hibernated studies have highlighted potential challenges for rapid activation. During a pandemic staff with specialist expertise in influenza serological assays working in selected laboratories would face a substantial increase in workload and consequently have limited research capacity. Maintaining expertise outside these centres, such as through the hibernated studies, would address this. Reduced availability of research nurses during a pandemic, due to sickness absence and reallocation to clinical duties could nevertheless still be an issue for some studies.
Senior author Professor Marian Knight said ‘All too often researchers are in apparent competition when trying to answer research questions rapidly in an emergency situation. Others have highlighted that the research response to the Ebola outbreak in parts of Africa was both late and inappropriately competitive. By contrast, the UK hibernated studies model allows for advance funding and planning of a complementary suite of studies, system testing, and development of a collaborative network of researchers.’
Large infectious outbreaks are not the only public health risk. Research to improve care is also essential in other public health emergencies such as natural disasters and the deliberate release of biochemical weapons as part of terrorist attacks. Similar models of hibernated studies could be developed to plan for research in these situations to generate the rapid evidence needed to guide policy and public health actions as well as clinical practice.