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Trial Managers, from the Primary Care Clinical Trials Unit (PC-CTU), share their experience of working with the Centre for Research Equity (CfRE) and community pharmacy to develop an innovative approach to primary care clinical research.

Photo of a smiling pharmacist working at fulfilling a prescription.

The NHS Pharmacy First Service (PFS), launched in January 2024, is revolutionising patient care pathways in the UK. By allowing community pharmacies to supply prescription-only medicines for common conditions, the PFS aims to alleviate pressure on GP appointments and reduce health inequities.

But beyond its immediate benefits, the PFS presents a unique opportunity to enhance clinical research recruitment, particularly within underserved communities.

Challenges for Clinical Research

The introduction of the PFS has raised concerns amongst some research active GP practices about its impact on recruiting participants for primary care-based clinical trials. With pharmacists now managing seven common conditions – such as earache, sore throat, and urinary tract infections – some patients are less likely to visit their GP, potentially leading to reduced recruitment in GP-based clinical studies. Our experience is that, since the introduction of PFS, GP practices we work with are struggling to meet recruitment targets for conditions covered by the PFS.

However, this challenge could be transformed into an opportunity. The evolving role of community pharmacists positions them as potential clinical research sites, which could address recruitment challenges both for the seven conditions covered by PFS, and beyond.

Additionally, since pharmacies tend to be embedded within all communities – regardless of affluence, race or religion – throughout the UK, pharmacies stand well placed to promote equity in research participation.

Leveraging Community Pharmacies for Research

Community pharmacies have already demonstrated their value in clinical research. For example, during the COVID-19 pandemic, pharmacies played a crucial role in the PRINCIPLE and PANORAMIC trials, significantly enhancing recruitment and promoting inclusion among underserved populations (1, 2). The Salford Lung Study further highlighted the effectiveness of pharmacies in recruiting participants and managing medications, proving their capability as research partners (3).

The PFS can potentially open doors to further expanding the role of pharmacies in clinical research. By considering pharmacies as active research sites, we can reach a broader, more diverse patient population. An approach that aligns with ongoing efforts at the PC-CTU and the CfRE to explore innovative recruitment strategies, including through community pharmacies.

Opportunities for Improving Research Equity

There are over 9,000 GP practices in England and not all of them would be involved in every primary care study! Moreover, with over 10,000 NHS community pharmacies in England, the potential to significantly extend the reach of clinical research through this sector could be huge.

Many people receive their healthcare primarily from pharmacies, particularly in underserved (i.e. lacking in adequate access to medical care) areas. In areas of highest deprivation 99.8% of the population have access to a community pharmacy within a 20-minute walk (4). By integrating pharmacies into the wider research ecosystem, we can reduce the ethnic, geographic and socioeconomic barriers that often exclude these such populations from participating in research.

This shift towards pharmacy-inclusive research could foster greater inclusivity, ensuring that the outcomes of clinical trials are more representative of the broader population. Enhancing research equity through community pharmacies is crucial for addressing longstanding health inequalities in the UK.

Moving Forward: Embracing the Opportunity

The Pharmacy First Service offers a promising pathway to strengthening clinical research recruitment and equity. However, realising this potential requires overcoming several challenges, including regulatory, operational, and training issues.

PC-CTU Trial Management teams are working to address these challenges in collaboration with the CfRE. The early work involves key stakeholders, such as community pharmacy chains and networks, and regulators – to develop a framework for establishing pharmacies as research sites. This initiative aims to identify and address the barriers to doing this, and to build a robust evidence base to support the integration of pharmacies into the clinical research landscape.

As Professor Mahendra G Patel, Director of the Centre for Research Equity, highlighted, "The COVID-19 pandemic has shown us that challenges can bring opportunities. The Pharmacy First Service could be a valuable opportunity to enhance inclusivity and diversity in clinical research recruitment and we should embrace it with optimism moving forward."

The journey to fully integrate community pharmacies as clinical research sites will, of course, be challenging, but the potential benefits can be immense. By leveraging the PFS, we can create a more inclusive and effective research environment that benefits all patients, regardless of where they receive their care.

In conclusion, the prospect of involving pharmacies as active research sites has been an eye-opener for the PC-CTU, and certainly inspired its Trial Managers to think more outside the box and with greater optimism in supporting and delivering inclusive research in the community.

References

  1. Patel MG, Dorward J, Yu LM, Hobbs FDR, Butler CC. Inclusion and diversity in the PRINCIPLE trial. The Lancet. 2021 Jun; 397(10291); 2251-2252
  2. Evans P, Tonner E, Williamson J, Dolman M, Chambers E, Crawshaw SE, Yu LM. The PANORAMIC study of COVID-19 treatments in primary care: a review and learning exercise. NIHR Open Research. 2024 Aug. https://openresearch.nihr.ac.uk/documents/4-46
  3. Leather DA, Howard S, Haydock G, Stephens L. Community pharmacy: a crucial enabler in creating the effectiveness study environment in the Salford Lung Studies. Int J Pharm Pract. 2020 Oct; 28(5); 528-533
  4. Todd A, Copeland A, Husband A, Kasim A, Bambra C. The positive pharmacy care law: an area-level analysis of the relationship between community pharmacy distribution, urbanity and social deprivation in England. BMJ Open. 2014 Aug;4:e005764. doi: 10.1136/bmjopen-2014-005764

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