The UK as a World Leader in Clinical Trials

Although the US and Canada typically top lists for clinical trials destinations, Europe still remains one of the most important regions.  When it comes to early trials, the UK still leads Europe.

According to the Association of the British Pharmaceutical Industry (ABPI), almost a third of EU clinical trial applications came from the UK during the 2010s, and it is well ahead of other research powerhouses— including Germany, Spain, and France—when it comes to trials in Phases I and II. That research was focused on innovative, relevant treatments and diagnostics for cancer (210 trials in 2017), immunotherapies (79), CNS (61), and cardio-metabolic diseases (83), according to a recent report. The nation has one of the oldest and most respected medical set ups in the world, and has been a global innovator and trend-setter for more than a century. In terms of raw economic contributions, it ranks 8th globally for Research and Development, with a strong annual GDP spend of 1.5%, of which almost $6 billion comes from pharmaceutical investment alone.

The Right Environment for Clinical Research
It’s worth understanding the factors that make the UK a unique environment for clinical trials, especially early on. The most significant is, of course, it’s National Health Service (NHS), which combines the data-rich, democratised, and uniformly organised approach to healthcare, common in northern Europe, with a diverse population equivalent to that of the United States. Its size alone makes it extremely useful as a context for research—the NHS assists a million patients every 36 hours. Add to that a highly stable population and detailed, lifelong medical records stretching back to 1948, and you have one of the best recruitment tools in the world.

In 2006, the NHS created the National Institute for Health Research (NIHR), which rapidly developed among the most robust research
infrastructure networks in the world. Improvements included standardising many of the networking, procedural, and bureaucratic elements involved in getting a drug from molecule to drug candidate stage. Ethics approval, for instance, is now granted nationally through the Integrated Research Approval System, rather than individually at every site or in every new network of care providers. The NIHR also created research networks for specific disease and patient groups, including cancer, diabetes, pediatric conditions, neurodegenerative disease, stroke, and mental health. The Medicines for Children Research Network (MCRN) alone now treats about 6 million children at more than 100 NHS sites every year—a tremendous asset given that trials in children are now required for drug approval in Europe and the United States.

Challenges
It is not yet clear how Brexit will affect clinical trials in the UK. An added degree of separation from Europe’s regulatory networks might make it even easier to establish new trials, but that same disconnect may make it harder to introduce drug candidates to a wider European market. There may also be challenges arising from conflicts with Europe’s data protections under the 2016 GDPR. Similarly, the ramifications of the Covid-19 pandemic for clinical trial progress are not yet known, although it is likely that a year of remote, digital collaboration will open new possibilities for distributed trials.

Those difficulties, however, are likely to be overcome relatively rapidly, thanks to the UK’s appeal as a location for medical research. A challenge that is less new has to do with recruitment of clinicians. The UK lags behind anticipated demand in a few key skill areas, including clinical pharmacology, immunology, and genomics. It’s clinical research networks also tend to over-emphasise the largest hospitals where clinicians are most pressed for time.

Despite those potential stumbling blocks, the UK should be on the radar of any biotech looking to quickly and efficiently initiate new clinical trial. For leaders in the life sciences, its approach to research infrastructure should be a model for future development, with streamlined and centralised web-based approval processes a major focus.