Professor Chris Butler of the University of Oxford’s Nuffield Department of Primary Care Health Sciences, and GP in the Cwm Taf University Health Board in Wales, is the lead investigator in the world’s largest clinical trial in the community of the controversial flu drug oseltamivir (Tamiflu). He explains the background to the trial and what the team are looking to achieve.
There is widespread uncertainty over whether people with flu symptoms should routinely be treated with antiviral drugs like oseltamivir – also known as Tamiflu - in the community, with a debate raging in the media about the drug’s use each winter. To help us get some answers about whether to treat, and if so, who might benefit most, we’ve so far recruited 2,000 people into a clinical trial to test the clinical and cost effectiveness of oseltamivir in primary care and provide some much-needed real world evidence about this treatment.
Led in the UK by our team in Oxford University’s Primary Care Clinical Trials Unit, and coming together with colleagues across Europe, the ALIC4E trial investigates whether oseltamivir is cost effective and beneficial to patients consulting their general practitioner with flu symptoms. In particular, it will understand if older people, infants, people with other health conditions, those treated early, or those with particularly severe flu can benefit from the treatment.
ALIC4E is the first publically funded randomised controlled trial of its kind to assess antiviral treatment for influenza in primary care and is a collaboration between researchers in the UK, The Netherlands and Belgium. Overall we aim to recruit at least 2,500 participants across 16 countries and, like most of our clinical studies in primary care, we do this by working closely with GP practices.
Since launching in 2015, 324 participants have been recruited across England and Wales - 138 in Oxford, 86 in Southampton and 100 in Cardiff, with the trial as a whole reaching the milestone of 2,000 participants this week.
The trial is an initiative of the Platform for European Preparedness Against (Re-) emerging Epidemics (PREPARE) consortium. Funded by the European Commission’s FP7 Programme, PREPARE was set up to support research organisations to respond rapidly to pandemics with clinical studies that can provide real-time evidence to inform the public health response.
The antiviral oseltamivir is a member of a class of drugs called neuraminidase inhibitors. These drugs are stockpiled and recommended by public health agencies worldwide for treating and preventing severe outbreaks of seasonal and pandemic influenza, yet some experts suggest the evidence supporting their use is lacking. The drug was widely used during the ‘swine ‘flu’ pandemic, for example, but no trial was done of its clinical and cost effectiveness.
Having reached the milestone of recruiting 2,000 patients into the critically important ALIC4E study is an incredible international achievement that is worth celebrating. Especially when there seems to be a particularly widespread flu outbreak, it’s a real shame that we don’t confidently know which people with symptoms of the flu should be prescribed antiviral drugs, and the cost-effectiveness of this treatment in terms of helping people return to their usual activities.
The resource implications for the health service and implications for patient well-being are considerable, especially given the debate around the effectiveness of antiviral treatment for influenza. By providing evidence through a study of this scale, the results will be of great interest to governments, policy makers, companies, practitioners, and members of the public.
We urgently need studies like ALIC4E embedded in everyday general practice to guide care for common and potential serious conditions, and address the questions that matter most to patients. We are working towards making it possible for people to participate in clinical trials within two weeks of a pandemic emerging, so evidence from these trials can then inform care during the pandemic itself, rather than those much needed answers coming along once the pandemic is over.