Investment in clinical pharmacology can support the UK to deliver trials across all phases of research. Clinical pharmacologists evaluate risk-benefit, through a structured approach to levels of evidence, mechanism, dose and safety. They advise on proportionate regulatory decisions, supporting trial set up and approval, whilst ensuring safety, effectiveness, and quality standards.
The RECOVERY trial did not require Principal Investigators to provide GCP certificates to take part. This was one of several examples, including the use of remote monitoring and site visits, that demonstrated how proportionate regulation could help the UK realise ambitions of setting up trials more quickly.
UK’s long-standing leadership in medicines regulation and safety also meant that the UK was able to prioritise assessment, and progress decisions quickly. The MHRA has played a vital regulatory role in supporting vaccine manufacture, licensing and global standards for COVID-19 vaccines. Professor David Webb, a clinical pharmacologist, is deputy Chair of the MHRA Board. Not only did MHRA support the rapid approval of a range of platform trials, including RECOVERY, the UK was the first country globally to licence the Oxford-AstraZeneca and Pfizer-BioNtech vaccines. Professor Sir Munir Pirmohamed (Chair of the Vaccine Benefit-Risk Expert Working Group) and other clinical pharmacologists including Professor Jamie Coleman were responsible for advising the MHRA through their role on the Commission for Human Medicines (CHM), ensuring COVID-19 vaccines meet the highest standards of quality, safety and effectiveness. Sir Munir was recently appointed Chair of the CHM, recognising his expertise and long-standing contributions to medicines regulation.
UK clinical pharmacologists also provided advice on the appropriate pathways to use for COVID-19 study approval via the MHRA, EU National Medicine Regulatory Agencies and the US FDA, and subsequently the possible regulatory emergency approval pathways. For UK based projects, advice and support was given in relation to applying for the NIHR Urgent Public Health Priority designation for medicines.
Further, MHRA post-Brexit innovative Licensing pathway[1] will require dialogue between industry and various groups that will involve clinical pharmacologists to bring innovative medicines to patients efficiently. University departments of clinical pharmacology might be nodal points that can provide regulatory science links to support the work of MHRA. For example, Professor Isla Mackenzie, Professor Tom MacDonald and colleagues have set up a UK-wide online study[2] to track COVID-19 vaccines and provide data to support vaccine monitoring that will report to the MHRA.
As therapeutic interventions become more complex, so do regulatory decisions. Clinical pharmacologists in the NHS, academia and industry have the expertise to consider risk-benefit decision making in innovative ways. For example, rethinking the boundary point at pre and post marketing assessment could help the UK to be a world-leader on real world evidence collection – more robust evidence of high generalisability in the clinical context would mean less need to collect data in large expensive trials. Interrogating risk-benefit across a product life cycle in this way could support therapeutics reach patients at an earlier stage. This is the area of regulatory science, and clinical pharmacologist will be able to work with the MHRA to maintain and strengthen the UK as a leading global regulator.
In addition to medical skills, enhancing the UK’s capability to deliver clinical trials will depend on investment in clinical pharmacology scientists. Following cross-sector consultation about the challenges in addressing scientific skills gaps, the CPSA worked with a Trailblazer Group to develop a Clinical Pharmacology Scientist (level 7) apprenticeship in response to industry concerns that there was not a clear training pathway for these important roles. The Clinical Pharmacology Scientist will design, analyse, interpret and report clinical research and clinical trials aimed at understanding what a drug is doing to the body (pharmacodynamics), what happens to a drug in the body (pharmacokinetics), and how it works in terms of treating a particular disease. They will also offer clinical pharmacology expertise to resolve issues that arise during conduct of studies. It is a varied role, supporting the discovery and development of new medicines, and improving understanding of existing ones. The apprenticeship was formally approved by the Department for Education in October 2020, and we are now working with partners to enrol the first intake of apprentices. An integrated approach to workforce planning should include investment in scientific and medical clinical pharmacology skills.
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References
- Medicines & Healthcare products Regulatory Agency (2020) About the pathway.
- VAC4COVID.