Royal Pharmaceutical Society

The delivery of the COVID-19 vaccine trials

by Julie Shenton, Lead Pharmacist; Industry Operations Manager; Deputy Quality Improvement and Innovation Lead; and Health Services Research Local Specialty Research Lead | LCRN West Midlands Core Team | NIHR Clinical Research Network (CRN)

COVID-19 has presented many challenges for pharmacy staff across all sectors, with pharmacy support for the delivery of COVID-19 vaccine studies being one example. From the very start of COVID-19, the development of a vaccine has been widely seen as the only way out of the pandemic. Clinical trials of vaccine candidates have and are still being delivered at an unprecedented scale and pace. This in itself is challenging for pharmacy staff managing clinical trials medicines, and in the UK, this has been compounded by vaccine studies being delivered differently, using regional delivery models and non-NHS sites such as sports halls etc.

A Pharmacy Research Delivery Group was established to help pharmacy staff involved in the delivery of the vaccine studies. The purpose of the group is to provide pharmacy staff involved in the delivery of COVID-19 vaccine studies with peer support. It has representation from each of the 15 Local Clinical Research Networks (LCRNs) in England and the Devolved Administrations.

The members of the group, who are regional representatives, are all pharmacy staff with experience in supporting research delivery across the NHS, whether as a clinical trials pharmacist or pharmacy technician in secondary care, an academic pharmacist, or a pharmacist already working with their local LCRN to support research delivery from a pharmacy perspective.

The group also has representation from individuals with technical expertise in various aspects of the management of clinical trials medicines, as well as representation from bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA).

The group supports the delivery of COVID-19 vaccine studies by giving pharmacy staff a forum in which to discuss issues and concerns they have regarding the studies with their peers. It also allows members to share knowledge and expertise with their colleagues. In addition, the group has served to facilitate the development of national approaches to various aspects of the management of clinical trials medicines for the COVID-19 vaccine studies, including closer working relationships with the HRA and with Chief Investigators and Sponsors. Members of the group who are regional representatives also provide a link to organisations involved in the delivery of studies in their respective regions both by fielding queries and disseminating information from the group.

Chairing the group has been professionally rewarding for me in my role as Lead Pharmacist for the Clinical Research Network in the West Midlands. It has enabled me to bring together people with shared interest and shared goals. The feedback has been great too, with several group members expressing their desire for the group to continue beyond the delivery of the COVID-19 vaccine studies and provide staff with ongoing support in relation to the delivery of clinical trials more generally.

Having the technology to meet virtually means this is something that can be facilitated going forward. I believe that collaboration at a national level not only gives pharmacy a stronger voice within the research community, but also means there is much less duplication of effort and much more shared learning. This will serve to increase the capacity and capability of pharmacy staff to support research delivery.

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