Since the COVID-19 pandemic there has been an increasing recognition that primary care in the UK is uniquely placed to undertake clinical research.
There is also an acknowledgement, however, that this setting has previously been relatively underdeveloped.
Primary care has recently been termed the ‘sleeping giant’ of research delivery.
UK general practice – as part of the primary care setting – has ‘cradle to grave’ clinical electronic health records for 99% of the UK population.
It also has a large number of general practices willing to undertake industry work and an ever-increasing track record of commercial trial delivery.
The ability, via GP clinical systems and digital tools, to rapidly identify potential participants, matching them to inclusion and exclusion criteria for trials across a vast range of acute and chronic disease, facilitates easy identification of patients.
This coupled with the invitation to their patients to participate in trials, building on existing healthcare provider relationships, is a unique selling point of research in UK general practice.
Trial of the century
In the last full year, primary care in the National Institute for Health and Care Research (NIHR) Clinical Research Network (CRN), recruited over 200,000 participants into non-commercial and commercial trials.
General practice sites provided 18% of all industry recruitment in the CRN with a further 186 GP sites acting as participant identification centres (PICs).
Innovative delivery models were employed in pandemic studies such as the non-commercial PANORAMIC study of molnupiravir and Paxlovid in high-risk individuals.
PANORAMIC recruited almost 30,000 participants into the largest randomised community trial of COVID-19 treatment in the world.
Furthermore, it was also the fastest recruiting randomised trial ever delivered through the Clinical Research Network in the CRN.
PANORAMIC was delivered completely remotely, using decentralised recruitment through a study website, but also an innovative hub-and-spoke model.
It used 4,509 spoke GP practices referring into 65 hubs, enabling large population coverage.
This demonstrated that innovative trial design, in this case a multi-arm platform study, can be effectively delivered in a primary care setting.
Patients were also signposted to the website through a variety of large-scale and accessible options.
The COVID-19 pandemic demonstrated the ability of GP sites to stand up and deliver commercial phase 3, but increasingly later phase 2 trials such as COVID-19 vaccine studies.
This effectively broke the mould concerning traditional primary care study delivery as we started to expand the capacity of general practice to deliver.
More recently the highly successful HARMONIE trial delivered 8,058 participants across three European countries and used a combined secondary and primary care model in the UK, recruiting from hospitals and general practices.
Sense check
For trials involving individuals with chronic diseases such as type 2 diabetes, asthma and depression, the prevalence of these disorders is significant. Therefore, a shift towards primary care makes sense.
A combination of research activity CRN data, from the Clinical Research Network and intentional community engagement allows sponsors to recruit participants in areas of maximal prevalence areas or underserved populations through engagement with neighbourhood general practices.
We have demonstrated this, for example, with the use of community and religious organisations, as well as professional regulators in the promotion of the PRINCIPLE and PANORAMIC studies.
The NIHR Clinical Research Network CRN Primary Strategy supports a programme of work to expand research in the primary care setting.
The increasing capacity of primary care to deliver life sciences industry trials should be built upon and encouraged, to enable more patients to have an opportunity to participate in research.
This aligns to the wider work of the UK Future Vision for Clinical Research and government response to the O’Shaughnessy review, which highlighted primary care as an underdeveloped area for commercial research.
Final analysis
All studies should consider, during their study design, whether primary care is an appropriate setting for their trials.
Recruiting in primary care, when it is the right setting, can increase the likelihood of success. Primary care is delivering effective and innovative research and has much more to offer.
Emma Tonner is National Medical Directors Clinical Fellow at NIHR and Philip Evans is Deputy Medical Director at NIHR CRN.
An academic GP, Philip has over 25 years’ experience of leading primary care research networks, both locally and nationally, and has contributed to world-renowned trials such as PANORAMIC and PRINCIPLE.
