At the end of March 2021, the Department of Health published a paper on the future of clinical research in the UK (available here). The paper, which received input from the NHS, regulators, medical research charities and the life sciences industry, sets out the government’s UK-wide vision for a more patient-centred, pro-innovation and digitally-enabled clinical research environment.
Over the past 14 months, UK clinical research has been at the front and centre of the fight against COVID-19. Regulators, the NHS and trial sponsors have worked together to facilitate large-scale COVID-19 studies. The general consensus is that this has been carried out quickly and effectively. This has enabled some trials to progress from prioritisation, regulatory and ethical approval to the first patient being recruited in mere days, rather than the many months it took before. The collaboration between Oxford University and AstraZeneca to develop one of the first COVID-19 vaccines is just one of the clinical research successes we have seen in response to the pandemic.
The UK government is keen to keep up the pace and its recent publication identifies five key themes for developing the future best practice of clinical research delivery in the UK:
- Clinical research embedded in the NHS
- Patient-centred research
- Streamlined, efficient and innovative clinical research
- Research enabled by data and digital tools
- A sustainable and supported research workforce
To make this vision a reality, several key areas for action have been identified. These include building upon existing digital platforms (such as NHS DigiTrials) to deliver clinical research as well as making access and participation in research as easy as possible for everyone across the UK, including diverse, rural and under-served populations. Innovation in research design and delivery, supported by technology, will enable research to be delivered more efficiently. For example, the University of Birmingham’s Dare2Think clinical trial is using digital trials infrastructure such as remote eConsent and data-enabled follow up methods to recruit 3,000 patients across England with atrial fibrillation. This will free up researchers to work on the research that really requires their input. Similarly, digitisation and better use of data will also help to reduce the pressure on researchers and healthcare staff.
In terms of the next steps in the clinical research sphere, further plans and strategies are expected to be published across the UK government and devolved administrations later this year setting out what will be delivered in the 2021–2022 period. This latest government paper has been welcomed by the National Institute for Health Research and forms just one part of many related policy ambitions and plans, including those set out in the NHS Long Term Plan and Life Sciences Sector Deals. There’s clearly an ongoing drive towards improving health in the UK through leading clinical research.
There is no doubt that the pandemic has accelerated many clinical research advancements. While this is in itself a real achievement, if the clinical research environment is to evolve, it is crucial that the lessons learned from the pandemic become entrenched in the UK’s future clinical research delivery.
At Stevens & Bolton we have helped, and continue to advise, a number of clients based in the UK and overseas on legal aspects around the setting up and carrying out of clinical trials, and other related issues such as agreements governing the exploitation of the results of clinical trials.
Elizabeth Butler