The Association of the British Pharmaceutical Industry (ABPI) has published its second annual report on the state of clinical trials in the UK (Report), in which it finds that, although the UK has been leading the rest of Europe in early-stage clinical research, many trials have been paused throughout 2020 due to the impacts of the coronavirus (COVID-19) pandemic, and that the UK now needs a strategy to restart non-COVID R&D safely and sustainably.
The Report highlights precisely where the UK clinical R&D sector is competitive, in the context of the international landscape, and where the UK falls behind other countries, including in phase III clinical trials, where the UK is third in Europe behind Germany and Spain. Further, while the UK ranks first in Europe for both phase I and phase II clinical trials, it is ranked second behind the USA in phase II.
Impact of COVID-19 on clinical research
The Report finds the UK’s COVID-19 R&D response has been impressive, with the UK government setting up a process for nationally prioritising, and approving urgent public health research studies. This has meant, however, 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 only 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 R&D. 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 the UK government to ensure system-wide diversity and inclusion of research participants and contributors.
The Report makes 4 recommendations on how the UK can transform the clinical R&D 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.
Recommendation 1 – The UK government should take urgent action to plan and implement the sustainable restart of non-COVID-19 clinical R&D at pace and scale, through the following measures:
a) to continue working collaboratively across the sector, and with patients and the public, to openly discuss and address the challenges of restart;
b) to develop a strategic plan for how the NHS will deliver clinical services and research (COVID-19 and non-COVID-19) sustainably;
c) 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; and
d) 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.
Recommendation 2 – 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:
a) optimising the processes for setting up and running clinical trials;
b) building a workforce fit for the future with opportunities for all to be involved in research;
c) harnessing the UK’s health data to support the efficient design, feasibility, recruitment and conduct of the full range of clinical trials;
d) driving continuing high standards for transparency; and
e) creating a regulatory environment, which supports innovation in the life sciences.
Recommendation 3 – The research community must continue to work with the UK 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.
Recommendation 4 – 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.
The ABPI concludes the pharmaceutical industry operates globally, and companies will continue to place their investment where they feel confident that their research can be efficiently and successfully delivered. Countries capable of approving and setting up cost-effective clinical trials efficiently and delivering on patient recruitment targets, whilst maintaining high patient safety standards, will succeed in attracting commercial investment in their clinical research environments. By embracing new and innovative approaches to clinical research design, delivery, and regulation, including data and digital technologies, the UK has the opportunity to transform how clinical trials are conducted, and to maximise benefits for the NHS, patients and the economy. A key part of this transformation will be bringing the NHS into the 21st century, with state-of-the-art infrastructure, and a research culture that is embedded in daily processes, and across the workforce. Following the COVID-19 pandemic, the UK must address the immediate challenges that lie ahead, ensuring that as it takes the stage on an international platform in 2021, the right interventions are implemented to deliver on its commitment of becoming a ‘science superpower’.
For the full Report, see: Clinical trials: How the UK can transform the clinical research environment