The Society, as part of the Clinical Pharmacology Skills Alliance (CPSA), today welcomes the UK-wide government vision - Saving and improving lives: the future of UK clinical research delivery - that aims “to create a patient-centred, pro-innovation and digitally enabled clinical research environment, which empowers everyone across the NHS to participate in delivering research and ensures that patients from across the UK are supported to take part in research that is of relevance to them”.
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The vision recognises the extraordinary challenges posed by the COVID-19 pandemic – particularly pertinent today as it was published a year after the first lockdown. Despite these challenges, it has been a year in which UK clinical research rose to the occasion. Researchers, healthcare professionals, industry, regulators, and participants have collaborated on world-leading trials, supporting global recovery from the pandemic by delivering proven treatments and vaccines.
Clinical pharmacology, a medical specialty and scientific discipline focusing on the safe, effective and cost-effective use of medicines, has been a golden thread running through the COVID-19 response, helping patients access evidence-based treatments and care. UK clinical pharmacologists have played a central role, with contributions that span research design, discovery, development and delivery (e.g., through running national platform trials like RECOVERY and developing potential interventions including monoclonal antibodies and vaccines), regulatory decision-making (e.g., through rapid approval of COVID-19 vaccines) and patient care (e.g., clinical leadership for surge hospitals in Cardiff and Birmingham, and advice on therapeutics in a time of uncertainty).
In this article we set out how clinical pharmacology can be a fundamental part of delivering the government’s vision – and we are asking government to partner with us on a workforce strategy that will enable it to do so.
For all its impact and potential, UK clinical pharmacology is at risk. Over the past few years, the CPSA has worked at a ground level to raise the visibility of, and recruitment to, clinical pharmacology. We have made great strides: filling all training posts in the most recent round and taking the number of UK clinical pharmacology consultants from 72 to 100. We have an ambition to reach 150 clinical pharmacologists by 2025. Based on calculations by PwC[1] , we estimate this would cost an additional £6.9m per year - but the same report showed that for every £1 invested, this would save nearly £6. Moreover, decision making about the medical workforce is split across the NHS, Health Education England, industry and local trusts, making it hard to be strategic about planning. Through investment and government support for a strategic coalition to drive growth of clinical pharmacology across the NHS academia and industry will build on the work that has underpinned research success in COVID-19 and realise the full potential of UK clinical pharmacology. Working together, we can grow a clinical pharmacology workforce that saves and improves lives on a national scale. If we do nothing, we risk losing a critical area of strength. The time to act is now.
Clinical pharmacologists are experts in the development and use of medicines. They investigate the mechanism of action of potential therapeutics, working to translate these into clinical use through the design and delivery of innovative trials, and ensuring safety and effectiveness through regulatory evaluation and pharmacovigilance. They support the uptake and implementation of therapeutics through health technology assessment, advise local formularies, drive prescribing education[2] and work on the frontline as general physicians who take an integrated approach to patient care. Their roles are critical across life sciences and healthcare.
The current Government Chief Scientific Adviser, Sir Patrick Vallance, is a clinical pharmacologist whose experience in R&D enabled him to drive the UK’s vaccine strategy and advise government on pandemic decision making at the highest level. Sir Patrick has reflected that principles of clinical pharmacology including dose, randomisation, evidence-based medicine and risk-benefit have been the “bread and butter” of discussions with government during the pandemic and should be at the heart of future UK clinical research strategy. Sir Patrick advocates for a leadership role for clinical pharmacologists as part of creating a vibrant and innovative clinical research and life sciences ecosystem for the future.
Clinical pharmacologists can help the government achieve its ambitions by supporting each of the five key themes in the new vision:
NHS staff and patients engaged with research at an unprecedented scale over the pandemic. Clinical pharmacologists led national platform trials including RECOVERY and AGILE, ensuring that partnership with NHS staff was embedded in trial design and delivery.
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Clinical pharmacologists can help reach more patients with research through de-risking early phase studies in primary care and the community. Safety is paramount in first in human studies and clinical pharmacologists are qualified to be principal investigators on such trials. Investment in clinical pharmacology can also support a patient-centred, evidence-based approach to care - for example through managing multimorbidity, problematic polypharmacy and a personalised approach to the use of medicines.
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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.
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Clinical pharmacologists can support the recovery of, and advance, non-COVID-19 research through innovative digital trials. This will help to not only widen participation in trials, but also enable quicker and more cost-effective recruitment, leveraging the huge benefits of the NHS at both primary and secondary care levels.
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Clinical pharmacology is one of the few medical specialties with research in its curriculum. Clinical pharmacologists are well-placed to support education and training of healthcare professionals. Clinical pharmacologists are currently developing introductory training for healthcare professionals to support research capability in the NHS.
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The vision sets ambitious goals to support the research capacity and capability of the NHS, as part of a patient-centred and integrated approach to care. Research drives better patient outcomes[3][4][5][6] but it still will not be easy to achieve the systems and cultural change that will be needed to realise the potential of this strategy. The vision rightly takes a step-wise approach, cognisant of the pressures on frontline service and NHS people at a still challenging time. It recognises the need to balance long-term goals with the short-term imperative to ensure recovery - of people and of research. Ultimately, it recognises the need to invest in, and support the workforce – so that recovery means recovering back better, so no one is left behind.
We fully support the ambition to develop a culture of research and evidence-based care. Clinical pharmacology can help, but it needs help. Implementation of the vision is the time to think carefully about the investment, stewardship, and creative training solutions[7] that can make this a reality. We are keen to work with the government and contribute to the Recovery, Resilience and Growth programme to help deliver the ambitions of this vision, which we share.
Next steps
We hope this article demonstrates the breadth of contribution that UK clinical pharmacology has made over the course of the pandemic – and could continue to make with appropriate and coordinated investment.
We congratulate government on its far-reaching and ambitious vision, recognising the challenges that still lie ahead and extending our support for the next phase of this work. In turn, with the right support from government, we can act as stewards of the UK clinical pharmacology workforce to help save and improve lives across the UK whilst also being a part of bringing forward the medicines that will see the UK recognised as a world-leader in the development of evidence-based therapies of the future. We look forward to working with government and the sector to develop the implementation plan that will deliver this vision, for the benefit of patients and the UK as a ‘science superpower’.
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References
- British Pharmacological Society (2016). Clinical Pharmacology and Therapeutics: The case for savings in the NHS.
- Prescribing Safety Assessment.
- Jonker L, Fisher SJ (2018) The correlation between National Health Service trusts' clinical trial activity and both mortality rates and care quality commission ratings: a retrospective cross-sectional study. Public health, 157, pp.1-6.
- Jonker L, Fisher S J, Dagnan, D (2020) Patients admitted to more research-active hospitals have more confidence in staff and are better informed about their condition and medication: Results from a retrospective cross-sectional study. J Eval Clin Pract, 26 (1) 203-208
- Boaz A, et al. (2015). Does the engagement of clinicians and organisations in research improve healthcare performance: a three-stage review. BMJ Open 5, e009415.
- McManus RJ, et al. (2008). How representative of primary care are research active practices? Cross-sectional survey. Family Practice 25, 56–62.
- Baber NS & Brown MJ. A new opportunity for training in Clinical Pharmacology. Brit J Clin Pharmacol 1996;41:365-368