Published: 08 August 2024
More consideration should be given to primary care studies from the very start of any pandemic, to prevent worsening of patient symptoms and reduce hospital admission.
This is one of the key recommendations of an NIHR paper about the learnings from the delivery of a major COVID-19 research trial, published today on NIHR Open Research.
Preparedness for the next pandemic is a key theme for the health and care research community.
Learnings from the study delivery will be useful not just in future pandemic research but in health and care research more broadly. This is especially the case for primary care as it is an expanding setting for clinical research. Over half all GP practices in England now taking part in clinical trials.
The PANORAMIC trial
In the early stages of the COVID-19 pandemic, much research was carried out in secondary settings on patients that were critically ill. But in Spring 2021, it became clear that there were some novel antiviral drugs that needed further evaluation in primary care.
Later that year, PANORAMIC (Platform Adaptive trial of NOvel antiviRals for eArly treatMent of COVID-19 In the Community) was born. Funded by NIHR, delivered by the NIHR Research Delivery Network (RDN) and equivalent networks in the devolved administrations, and led by the University of Oxford. It is the fastest recruiting and the largest trial of a therapeutic agent for COVID-19 ever in primary care.
The trial has inspired other studies globally including the CanTreat COVID study in Canada.
Main recommendation
The 80-page paper, authored by Professor Phil Evans, GP and Deputy Health and Care Director and team at the NIHR Research Delivery Network together with colleagues from the University of Oxford, concludes that primary care research should be at the forefront of future pandemic preparedness.
Other recommendations for future pandemic studies
Positioning primary care at the frontline of pandemic research is the key theme of this paper. But it also sets out a number of other recommendations for the future.
1. Platform studies should be the blueprint for future pandemic research in primary care
PANORAMIC was a platform study. This is a special type of research study that allows the standard of care to change, and allows the trial to evaluate several candidate drugs at the same time. This has the benefit of finding out earlier how effective an intervention is. So changes can be made through emerging evidence while the trial is ongoing.
2. Work should be undertaken to see how recruitment could be enhanced in care homes
PANORAMIC only recruited 0.8% of participants from care homes. Complex contracting requirements and patient capacity proved to be barriers to participation. Putting letters of agreement in place with the next of kin or power of attorney would potentially speed up the process for future studies.
3. Ways of delivering medicine to sick people at home, without the need for a local trial pharmacy, should be further evaluated
Ways of rapidly delivering medicine directly to participants at home should be further evaluated in trials. Lessons learned could then be applied to clinical deployment, if the medicine is found to be effective.
4. Building trust with diverse communities and their leaders so that research is as inclusive as possible
Building relationships with community leaders should be prioritised so that they can help broaden awareness of research in future scenarios. In this study, the team worked with diabetes nurse specialists so that they could promote the study to vulnerable and ethnic minority patients. They also co-created videos with young advocates who have learning disabilities.
Pharmacies promoted the PANORAMIC trial through their outlets and websites via posters. These have a footprint throughout the UK and are invaluable in reaching out to underserved communities.
Lead author, Professor Phil Evans, GP and Deputy Health and Care Director at the NIHR Research Delivery Network explains:
“PANORAMIC recruited just under 30,000 participants into a randomised platform trial using innovative methods of recruitment - such as self referral through a website coupled with recruitment through a GP hub and spoke model - that had not previously been tested in a primary care setting.
“For this reason, PANORAMIC has been recognised globally as a trailblazing study for primary care, this is evidenced by the fact it has inspired a similar trial in Canada and the results have been used in other nations to inform policy. The study itself was recently recognised as highly innovative and was awarded the prestigious 2024 UK Prix Galien Award for Best Public Sector Innovation in May 2024.
“I would encourage all those involved in primary care research both in the UK and beyond, to read the paper in full. The research community is committed to sharing knowledge, and we have been open in this paper about what went well and what didn’t go so well, so that we are all better equipped to deal with similar situations in the future.”
Professor Lucy Chappell Chief Scientific Adviser to the Department of Health and Social Care and CEO of the NIHR said:
“The PANORAMIC study was central to the UK’s approach to COVID-19. Today's learnings paper shows the importance of engaging with primary care and the impact the innovative study had on the direction of the pandemic.
"Almost 30,000 participants were able to take part in the study from home, utilising couriers and the postal service. We are very grateful for all of those who gave their time to take part in this study, without whom the success of the study could not have been realised. This paper comes on the back of news that over half of all GPs in England are now taking part in clinical trials. Expanding settings for clinical research will only bolster our capability to improve access to research for patients and the public, closer to home.
“The study has given us a legacy of record-breaking trials in primary care and the community. These new ways of working have had far reaching impact, inspiring global studies as well as being recognised in guidance for future public health leaders."
Professor Chris Butler, Professor of Primary Care at the University of Oxford and Co- Chief Investigator of the PANORAMIC trial said:
“The incredible value that the NIHR brought to this trial enabled the UK to deliver for the world and for our citizens so well. The NIHR, and the CRN enabled the clinical research infrastructure in NHS primary care to be ‘stood up’ to support the study. The UK is unique in having this infrastructure exclusively devoted to efficiently delivering studies on its portfolio, predominantly in the NHS.
“In addition, the CRN provided research staff at many of the English hub sites to facilitate recruitment, promoted the study across the network, liaised with NHS England, devolved nations and UK government and monitored recruitment through a dedicated app. We are also so very grateful to the analogous organisations in the devolved nations who made this a truly UK-wide trial.”
Andrew Pinto MD MSc, Director, Upstream Lab, University of Toronto; Chair, Canadian Primary Care Trials Network said:
"The PANORAMIC study has been such an inspiration to us in Canada. It has directly informed the design of our own national adaptive trial of COVID treatments in out-patient settings, which we call CanTreatCOVID.
“Leaders from PANORAMIC came to Toronto to present on statistical methods this past fall at an international conference on adaptive platform trials. This sort of international collaboration helps advance primary care research as a field, but also helps prepare us for future pandemics. Governments around the world want to be able to get trials started within weeks - something that the team behind PANORAMIC were able to do."