Throughout the pandemic, primary care has provided invaluable support for the delivery of many vital clinical research studies to help us further understand the disease itself and identify innovative treatments and preventions. It’s crucial that we take key learnings and experience from the past 24 months to help strengthen primary care research moving forward.
A number of Covid vaccine studies have run across GP sites in the UK, helping to provide the important data which has shaped the vaccination programme. Studies including Janssen’s Ensemble 2, Novavax and the initial Oxford/AstraZeneca vaccine trial are just some of the studies which have been delivered through primary care.
The relationships and reach into local communities which general practices offer has proved vital for many Covid studies throughout the pandemic. Both rural research settings and inner-city practices covering areas of high deprivation have the reach and potential to enable more people in traditionally under-served communities to take part in and potentially benefit from cutting-edge Covid research.
The skills, experience and value that ‘research-ready’ general practices are able to add to the delivery of clinical research has never been more apparent than in the case of the national-priority Covid antiviral study, called PANORAMIC. The ground-breaking platform trial is rapidly generating the evidence to enable widespread clinical deployment of a range of potentially game-changing, orally-administered Covid antiviral treatments – that can be safely taken at home. It brings together GP practices, as well as NHS 111, Test and Trace, care homes, pharmacies and other NHS and social care service providers UK-wide – all of whom are playing a vital role in supporting participation in the study.
Since its launch in early December 2021, with the support of GPs right across the country, over 22,000 volunteers have stepped forward to join the study from every corner of the UK. This phenomenal rate of recruitment makes PANORAMIC the fastest ever recruiting study of its kind – with no other UK primary care interventional study achieving this level of recruitment, surpassing 10,000 participants within the first two months, and 20,000 less than four months in. Although smaller studies into molnupiravir and Paxlovid, have taken place (leading to MHRA conditional marketing authorisation for both treatments last year) – the number of participants involved is only a fraction of those enrolled by PANORAMIC – which is now by far the largest clinical trial in the world of community-based treatments for Covid.
But with thousands more participants needed to establish the efficacy of each new antiviral treatments in a predominantly vaccinated population (in addition to a new virology sub-study investigating the effects of these treatments on viral shedding and possible antiviral resistance), GP practices continue to play a key role in recruiting participants and delivering this pivotal trial.
The potentially game-changing treatments tested through this primary care-led trial could help clinically vulnerable people with Covid recover sooner, prevent the need for hospital admission and so ease the burden on the NHS and healthcare systems around the world. GPs from right across the UK are playing a leading role in making this happen.
In addition, the importance of the role primary care has played with Covid vaccine research cannot be overstated. At the time of writing, over 300 individual primary care sites have participated in clinical Covid vaccine trials in England, with nearly 2,500 participants recruited so far.
At an individual practice level, two West Oxfordshire GP practices came together to run the Phase 3 ENSEMBLE 2 vaccine study, assessing the safety and effectiveness of the sponsor’s two-dose regimen vaccine. Windrush Medical Practice, Witney and Eynsham Medical Group, Eynsham were the only UK GP sites to recruit to the ENSEMBLE 2 study. In total, they recruited 478 participants, between November 2020 to April 2021, with some participants travelling over 60 miles to be part of the trial. More than 100 staff from secondary care were also brought in to work on the study at different times.
Other examples of vaccine studies within primary care settings include, the Cripps Health Centre, in Nottingham. A total of 549 volunteers were recruited at the practice as part of the Oxford/AstraZeneca study (achieving higher recruitment than many secondary care sites) which led to the roll-out of the approved vaccine. A further 111 people were recruited to the Com-COV study, which looked at whether different vaccines can be used for the first and second dose.
The team at the Lakeside Health Surgery in Corby, recruited 634 participants for the largest Phase 3 vaccine study in the UK, Novavax – which showed it was 89.7% effective at preventing Covid and was authorised by the MHRA in February 2022.
Other practices across the country texted potentially eligible patients who would then be seen in the local vaccine hub. At other sites, GPs returned from retirement helped deliver vaccine studies.
Many hurdles have been overcome in the setup of these trials, including logistics around blinding participants and clinicians to vaccines administered, sample couriering and using lab facilities, as well as follow-up of potentially infected patients. Each study carried out has done so on a large scale and each requires massive logistical and operational planning. Support to GP practices through the NIHR Clinical Research Network has enabled this to take place, to help set up each trial and provisions for research nurses to carry out the studies to time and target.
The pandemic has led to a sea change in the way that we approach primary care research. Innovation in the delivery of research studies, as well as the need to recruit at scale and pace provided a potent stimulus to primary care research. Although seeded in Covid research this will undoubtedly transfer to research in other diseases.
It has demonstrated that GP practices can deliver complex studies as sites, but also signpost patients in virtual trials to the trial website, such as the PRINCIPLE study. Prior to the PANORAMIC study, this was the largest community-based study of treatments for Covid in the world, run by the University of Oxford’s Primary Care Clinical Trials Unit (who are also leading the PANORAMIC trial). We will be looking for greater resourcing of primary care research in the light of the emerging NIHR Clinical Research Network Primary care Research Strategy to capitalise on this wave of interest in research. This may include incentivisation of research in general practices and above all promotion of research as being an essential part of clinical care – the message that has come loud and clear from the pandemic.
Throughout the pandemic, the primary care research community has grown considerably and allowed more people across the country to become involved in vital studies, not just vaccine trials, all nearer to home. There have been a total of 42 Covidstudies carried out within primary care settings, recruiting over 100,000 participants. This contribution, via our 15 NIHR local Clinical Research Networks, will have a significant impact on discovering further preventions and treatments for Covid and will leave a lasting legacy within primary care when it comes to research delivery.
At the NIHR, we hope that the discoveries and accomplishments of clinical research have inspired healthcare professionals across primary care to continue their research journey, to support the delivery of NIHR studies but also to develop their own research projects.
Professor Philip Evans is national specialty lead for primary care at National Institute for Health and Care Research Clinical Research Network. He was speaking as part of the NIHR’s Your Path in Research campaign. To find out more about delivering research in your community, and discover the relevant research contacts in your region, explore the NIHR Clinical Research Network website today.