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Beyond COVID-19: Innovations and Future Horizons in Clinical Research

 A new future for Academic Clinical Trial Unit medication dispensing

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Photo: Early days of PRINCIPLE trial medicines process. Mona Koshkouei, our Principal Pharmacist, is carrying out a quality check of over-labelled Budesonide Inhalers during the height of the pandemic within the Clinical Trial Unit (CTU). This was the first trial where the Primary Care CTU (PC-CTU) carried out the labelling and distribution of medicines directly to participants and paved the way for the PC-CTU becoming the first academic CTU to have an inhouse Dispensary and Good Manufacturing Practices (GMP) Facility.

 

The MHRA licensed GMP Facility has allowed us to further expand our pharmacy capabilities within the PC-CTU. We now have the ability to not only dispense trial medicines and distribute them directly to participants, but also to carry out labelling and other manufacturing processes. We have created a sustainable and financially viable model for running clinical trials and in so doing introduced an additional skillset to our flourishing CTU activities
- Mona Koshkouei, Head of GMP Operations and Principal Pharmacist

The fight against the COVID-19 pandemic has not only demanded ground-breaking vaccines and treatments but also innovative approaches to conducting clinical trials. The Nuffield Department of Primary Care Health Science’s Clinical Trials Unit (PC-CTU) has risen to this challenge with the remarkable services provided by its in-house Dispensary and Good Manufacturing Practice (GMP) Facility.

The PC-CTU Dispensary was born out of necessity during the COVID-19 pandemic when the rapid setup and delivery of clinical trials became paramount. The tried, tested, and proven methods for handling and distributing trial medication under the supervision of the PC-CTU's Principal Pharmacist has allowed a decentralised approach to running a clinical trial. The success of the decentralised approach goes beyond PRINCIPLE and PANORAMIC and offers a chance for the PC-CTU to bring research more effectively into the community. 

 

 The Centre for Research Equity

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One of the most significant outcomes of the PANORAMIC trial's work in diversity and inclusivity is the establishment of the Centre for Research Equity. Supported by the NIHR ARC OxTV  (the National Institute for Health and Care Research Oxford and Thames Valley Applied Research Collaboration, who research solutions to the health and social care priority problems of local people, NHS and social care services, as well as broader national priorities) and led by Professor Mahendra G Patel OBE, the Centre aims to increase research equity by breaking down traditional barriers in clinical research, including socioeconomic, religious, and cultural barriers.  

It is already fostering new partnerships, such as with Northern Ireland, and is set to be a hub for developing inclusive research practices. For Professor Patel, the Centre is also a personal milestone, reflecting a commitment to lasting change in how clinical research is conducted. 

Find out more about the Centre here