UK leads Europe in clinical trials, but strategy needed to restart non-COVID research

Hands holding test tube and pipette

The UK has been leading the rest of Europe in early-stage clinical research according to new data published by our partner the ABPI in its second annual report on the state of clinical trials in the UK.

However, as a result of many trials being paused earlier this year due to COVID, this position is precarious – the UK needs a strategy to restart non-COVID research safely and sustainably, in what would be the first critical step in the journey to recovery following the coronavirus pandemic.

The report looks at the research environment and compares how the UK performed against other countries in Europe and in other key countries in the world.

Cancer remains the top area for UK clinical trials, with 226 trials taking place in 2018. Research on the immune system coming next with 94 trials.

The data shows that the UK was leading the rest of Europe in the number of early-phase clinical trials started here. We also led in Europe for Phase II trials – where a drug is tested on larger numbers of people.

Moving into later stage Phase III clinical trials, where thousands of patients participate, the UK ranked third in Europe behind Germany and Spain, and fourth globally behind the USA. While this is an improvement on the previous fifth-place ranking, there is an ambition to improve further to meet Government target for the UK to become a science superpower.

The USA continued to lead globally in clinical trials for all phases of research.

Improving the UK’s performance in later-stage clinical trials could have significant benefits for patients, who would have better access to potentially life-saving treatments through research.

The report also highlights the benefits to the NHS through significant funding from life science companies. The report shows:

The report finds that UK’s COVID-19 R&D response has been impressive, with Government setting up a process for nationally prioritising and approving Urgent Public Health Research studies. However, this has meant that some non-COVID research has been paused.

As of 9 September 2020, data from the NIHR Clinical Research Network has shown that non-COVID studies are restarting, with 45% of studies open to recruitment and 36% of those recruiting since 1 June.

The report notes increasing concern across the research and healthcare sector around the UK’s progress on the restart, particularly with the second wave of COVID-19 threatening further disruption.

The ABPI is calling for the UK Government to create a strategic plan for the safe and sustainable restart of non-COVID clinical research, recognising winter challenges and the potential for future waves.

Patient involvement in clinical research

Throughout the pandemic, research teams have found it challenging to involve patients and the public in the design and conduct of their research. With the ambition to research and develop new vaccines and treatments for all in society, there is a critical need to ensure patient involvement is embedded across the research environment.

The ABPI and industry want to work across the life sciences sector and with Government to ensure system-wide diversity and inclusion of research participants and contributors.

Chief Executive of the ABPI Richard Torbett said:

“The UK performs very well on the world stage in clinical trials, but COVID-19 is presenting us with many challenges. It is crucial that the Government has a plan for the safe and sustainable restart of non-COVID trials, recognising the extra pressures the NHS is facing.

“By embracing new and innovative approaches in research we have the opportunity to transform how clinical trials are conducted in the UK and maximise the benefits for the NHS, patients and the economy.”

Aisling Burnand MBE, CEO of AMRC said:

“Clinical research is vital to the development of new treatments and improved understanding of disease. For many patients, it is a crucial lifeline – not only benefitting their potential futures but also those who right now are being offered experimental treatment opportunities where there may be no other options.

“COVID has seriously affected the ability to carry out clinical research in the NHS on all other diseases. The decision to suspend clinical trials has had a significant impact on participating patients and their families. As the number of COVID cases decreased, the process of restarting clinical research began and medical research charities have been working alongside government, industry and the regulators to get non-COVID clinical research restarted. Some progress has been made but it is clear that a restart is very challenging. As we navigate the next phase of the pandemic, it is vital that we don’t lose this progress.

“To realise the potential of the life sciences in the UK, and to maximise opportunities to make a difference to patients’ lives, research opportunities must not be passed up.”

Dr John Williams, Managing Director of Birmingham Health Partners, said:

“In order to maintain the UK’s international position in clinical research, it’s vital that we’re able to not only sustainably restart non-COVID-19 research, but to continue to open new studies too. This can only be achieved by designing in resilience.

“Contingency plans – which still allow compliance with regulations – are needed for every stage, and this may include fewer physical participant visits, electronic data collection and innovative trial design. Through the pandemic, the NHS and the UK’s academic and industry researchers have shown the ability to rapidly mobilise new studies in the face of a novel disease, and we now have the opportunity to use that collective experience to reassess our approach to setting up and running our clinical research.”

William Van’t Hoff, Chief Executive of the NIHR’s Clinical Research Network said:

“The ability of the UK’s research response to COVID-19 to rapidly develop, deliver and translate research into NHS practice has been remarkable. It is a testament to the world-leading expertise and research structures developed across the whole nation.

“Whilst we fully recognise the challenges in recovering the UK’s research capacity, I also see real commitment across the NHS, NIHR, HRA, MHRA and R&D leadership, working with ABPI and charities, that demonstrates the enduring strength of our sector.”

Professor Cheng-Hock Toh, Academic Vice-President of the Royal College of Physicians added:

“COVID-19 has shone a light on the pivotal role clinical trials play in improving patient care. It has also led to long-overdue improvements in how quickly trials can be set up.

“But a key obstacle still holding back clinical research in the UK is clinicians not having the time to participate, despite their keenness to become more involved. This problem is particularly acute in rural areas, where a recent RCP survey found that 40% of those in rural hospitals who are not research-active would like to be.

“As clinical research restarts across the country, targeted support from NHS England and NIHR is needed to address this discrepancy – allowing smaller NHS trusts in rural areas to participate more actively in clinical trials and deliver better outcomes for their patients.”

The report makes further recommendations on how the UK can transform the clinical research environment, including increasing investment for key organisations which drive and facilitate research and the importance of placing research and innovation and the heart of the UK’s trade strategy. Click through the accordions below for further detail on each of the four recommendations. 

The UK Government should take urgent action to plan and implement the sustainable restart of non-COVID-19 clinical research at pace and scale, through the following:

      • To continue working collaboratively across the sector and with patients and the public, to openly discuss and address the challenges of restart.
      • To develop a strategic plan for how the NHS will deliver clinical services and research (COVID-19 and non-COVID-19) sustainably.
      • To articulate a leadership commitment across all organisations (DHSC, NIHR and NHS), to restarting non-COVID-19 clinical research with an appropriate timeframe that recognises winter challenges with a clear message to the NHS, clinical trial sponsors and patients, on the importance of research across all disease areas.
      • To communicate a clear message to the NHS, clinical trial sponsors and patients, on the importance of non-COVID-19 research, demonstrating the UK’s commitment to research in other disease areas.

Transform the UK clinical research environment with investment to increase levels of research beyond pre-COVID levels, by increasing investment for the National Institute for Health Research (NIHR), Health Research Authority (HRA), Medicines and Healthcare products Regulatory Agency (MHRA) and other organisations which drive and facilitate clinical research across the UK.

The changes needed include:

      1. Optimising the processes for setting up and running clinical trials
      2. Building a workforce fit for the future with opportunities for all to be involved in research
      3. Harnessing the UK’s health data to support the efficient design, feasibility, recruitment and conduct of the full range of clinical trials
      4. Driving continuing high standards for transparency
      5. Creating a regulatory environment which supports innovation in life sciences

The research community must continue to work with Government, funders, and the public, to tackle issues around diversity and inclusion, ensuring all patients across the UK have the opportunity to be involved and engaged with research.

To make research and innovation central to the UK’s trade strategy, the UK Government must provide clear guidance on the operational environment at the end of the UK’s transition period with the EU, to ensure sponsors can continue conducting their clinical trials in the UK and beyond, with minimal disruption.

The UK Government must also agree a deal with the EU that establishes close cooperation on research and innovation, to ensure the UK has the best opportunity to collaborate and lead internationally with other regulators.