How the Pharmacy team support research at PRC: Leicester
The National Institute for Health Research (NIHR) Patient Recruitment Centre (PRC): Leicester is supported by the Pharmacy Clinical Trials service at its host NHS Trust, the University Hospitals of Leicester. Pharmacy support for PRC research is led by Clinical Trials Pharmacist, Michael Baker-Kukona and the Pharmacy Clinical Trials team at the Leicester General Hospital.
The Pharmacy Clinical Trials team are involved from the early stages of the research setup process for any potential PRC studies involving medicines. Initially they provide support and information to determine the feasibility of such studies. This includes assessing whether there is adequate equipment, facilities and staffing in order to open and recruit to target within agreed timelines. This will also include a clinical review of the protocol and a safety assessment of the current medication data available at that time. During this trial setup phase, the Pharmacy team will also take part in contract negotiations directly with the research sponsor or Contract Research Organisation (CRO) and ensure all regulatory approvals are in place before giving approval for the trial to proceed at our site.
Michael explains: “One of the benefits of being part of the PRC is that it has created a network of PRC Pharmacists across the UK that can collaborate and share ideas and best practice. One of the areas we are currently working on as a group is Pharmacy input into the PRC single costing model to help to standardise and speed up contract negotiations for PRC studies.”
Once PRC: Leicester agrees to host a study involving medicines, the Pharmacy team will ensure that the study medicine is procured, handled, stored and used safely and correctly according to the study protocol and the standards of Good Clinical Practice (GCP). This involves maintaining accountability logs of all study medicines and storing medicines in a secured and temperature controlled area. In addition the Pharmacy team will create and train staff to use study specific standard operating procedures (SOPs), prescriptions and preparation worksheets.
The Pharmacy team will also risk assess any new therapies to ensure the safety of our staff. For example, if a study medicine could potentially be harmful to staff we may require them to wear certain personal protective equipment (PPE) and/or dispose of medicines waste in a particular way. For some double-blind studies the Pharmacy team are the only staff on site unblinded to study treatment allocations. In these cases, the Pharmacy team play an important role in dispensing the study medication in a blinded manner, ensuring subjects and research staff remain blinded, thus maintaining the integrity of the study design and trial data.
In November 2020, PRC: Leicester opened an urgent public health COVID-19 vaccine trial, ENSEMBLE- 2. The study set up, including the Pharmacy review and approval, was completed within 12 weeks from protocol receipt to the first participant recruited. The PRC recruited all its initial target of 350 participants six weeks after recruiting the first participant. In total 569 participants were randomised, compared to the global and UK recruitment averages which were 255 and 372 respectively.
The Pharmacy team played an integral role in the success of ENSEMBLE-2. They dispensed and delivered each one of the nearly 1000 vaccine doses to PRC: Leicester during this trial. This helped to free up other members of the study team to focus on other study tasks. This also required regular communication between Pharmacy and the study team throughout each vaccination session.
Michael explains: “This trial, in particular, demonstrates the scale of what PRC: Leicester is capable of when all our services work together as one team. I feel this trial provided an opportunity for all of our research services to work together and bond, making our PRC: Leicester team even stronger. Pharmacy is just one of the many services that deserve recognition for their hard work on this study. As you can expect, working on a large scale trial during a global pandemic came with many challenges, but we were always able to overcome these and learn from our experiences. Overall, I am really proud to have been part of this trial and the contribution our Pharmacy Clinical Trials team was able to make to COVID-19 research.”
Adrian Palfreeman, consultant in infectious disease at Leicester’s Hospitals and Principal Investigator for the trial, said: “The Pharmacy support for ENSEMBLE-2 was fantastic. The engagement, commitment and prompt delivery of trial Investigational Medicinal Product (IMP) despite the pressures on Pharmacy of the ongoing COVID-19 crisis was something the team should all be proud of.”
Michael brings 12 years of hospital Pharmacy experience to the PRC: Leicester team. He has worked as a Pharmacist in both the USA and UK in a number of specialist areas including: diabetes, care of the elderly, general medicine and electronic prescribing. He joined UHL in 2015 and has been part of the UHL Pharmacy Clinical Trials team since 2019. He has as supported PRC: Leicester since it was established in November 2020.
To find out more about how PRC: Leicester can deliver commercial clinical research, visit the website: https://local.nihr.ac.uk/prc/leicester/industry/