Future proofing the UK’s research ecosystem in the face of global change
The UK is a powerhouse of clinical research but maintaining that leading position – and all the benefits that come with it – in the face of global change requires adaptation.
Over the last decade, an average of 28% of all clinical trial applications (CTAs) in the EU have come from the UK, which conducts the most Phase I and Phase II studies in Europe.
This success has been built on the ability to attract investment and research to the country’s “world-famous universities and research centres”, according to a report from the Association of the British Pharmaceutical Industry (ABPI).
Clinical Trials: How the UK is Researching the Medicines of the Future, says that the sector needed to remain competitive in the face of increasing competition and growing uncertainty.
“Clinical trials are important for patients, they are beneficial to the NHS and they are good for the UK economy,” says the report.
“Figures from the National Institute of Healthcare Research show that in England, clinical research is worth £2.7 billion a year – including £1.5 billion from commercial sources – and supports more than 47,000 jobs.”
What’s more, additional revenues and cost savings, such as providing medicines to trial participants, save the NHS around £28.6 million a year.
“If we are to continue attracting international pharmaceutical companies, we must maintain and strengthen the UK offer for clinical research,” says the report.
Strengths and weaknesses
The UK leads the way in early clinical research but falls behind other European countries in Phase III clinical trials.
Data collected by the ABPI shows that the UK ranked first in Europe for the number of early clinical trials started in 2017, with 147 Phase I and 253 Phase II studies being recorded.
It was a different story for Phase III trials, however, with just 243 starting in the UK in 2017, meaning the country ranked third in Europe, behind Germany and Spain.
“The UK has turned its strengths for early phase clinical research into a globally competitive asset,” say the report’s authors.
But while the sector has many attractive features, it faces two challenges: stiff international competition and a weakness in later phase research.
While European countries continue to invest heavily in science and healthcare, nations like China and Brazil are emerging as global medicines discovery hubs.
Says the report: “The UK has historically set itself apart from other countries with its enviable early stage research offering.
“It has consistently led Europe and holds its own against the USA and China in early stage clinical trials, however, it runs the risk of losing out to existing and emerging competitors – and failing to carry research through to later stages of research and healthcare delivery.
“Disinvestment would be detrimental to the UK economy and to NHS patients, with the benefits of clinical research lost and patients missing out on access to new and innovative medicines.”
The report calls on the Government, which has already committed to spending 2.4% of GDP on R&D by 2027 and 3% by 2030, to continue to support the sector.
“To remain globally competitive, the UK must continue to invest in R&D and support the evolving clinical research environment,” says the authors.
“Similarly to China and Germany, the UK should invest in healthcare system infrastructure, the workforce and innovation to ensure speedy set-up of clinical trials, competitive patient recruitment and uptake of innovation in clinical research delivery.”
Despite the number of CTAs remaining steady since 2012, confusion over what the post-Brexit research environment might look like could also negatively impact clinical trial investment, says the report.
“Because clinical trials are conducted over several years, any impact on activity will not be seen in datasets for another few years,” say the authors, adding that continued uncertainty about the future UK-EU relationship undermined the attractiveness of the UK as a clinical research destination.
Research stability, the ability to trade, a common regulatory framework and access to the best talent – which all impact upon the UK’s clinical research environment – are essential to the sector’s strength after Brexit, the industry believes.
“Securing any continued international R&D investment and collaboration between the UK and the EU will largely depend on the regulatory framework the UK has in the future,” says the report.
“In particular, participating in the EU regulatory framework for medicines and having continued access to the EU clinical trials database are critical for ongoing future clinical trials in the UK.”
Rising to the challenge
The private and public sectors will need to work collaboratively to maintain the stability seen since 2012, and to future proof the UK’s life sciences ecosystem, says the report, which makes seven recommendations on how this can be achieved.
These include increasing investment and simplifying the process of setting up and running clinical trials, as well as building a workforce “fit for the future” and harnessing the UK’s data infrastructure for medicines R&D.
The report also calls for patient involvement and transparency standards to be embedded into clinical research, and a future UK-EU relationship that allows for regulatory and research alignment.
“Clinical trials are good for patients, good for the NHS and great for the UK economy. But there’s plenty more to be done to make the UK the best place in the world to research, develop and deliver new medicines,” it says.