We hear constantly about the threats of Brexit to the UK economy, and there is no doubt that it does indeed endanger many aspects of the country’s world-class life sciences sector.
Yet this politically driven crisis has also illustrated some encouraging, positive factors for UK life sciences: its underlying strength and resilience, and most encouragingly, the ability of different stakeholder groups to come together to strengthen the country’s clinical trials ecosystem.
The life sciences sector is unquestionably one of the UK’s most important industries: world-class research universities; strength in clinical and translational medicine in the NHS; longitudinal data sets; the largest biotech sector outside the US, and a leading edge in emerging fields such as digital health and genomics.
The nature of this deep-rooted ecosystem means that despite the huge disruption posed by Brexit, leaders in the UK clinical trials field argue that many of its strengths will remain relatively unaffected.
James Brook is head of UK and Ireland clinical delivery at IQVIA, one of the biggest contract research investors in UK clinical trials.
He said the shock of Brexit has helped spur into action all the key players in the government and NHS: the government’s Office of Life Sciences, NHS England and the National Institute for Health Research (NIHR) and the UK’s medicines regulator the MHRA.
“Brexit has been a positive catalyst for change in the clinical research environment in the UK. It has led to a significant increase in the focus on the commercial research activity and the value of commercial research activity to UK Plc,” said James Brook.
He said it has driven “enhanced and enlightened engagement” between these organisations and pharma companies, biotech and clinical research organisations such as his own.
That’s because Brexit means the UK will have to fight to secure long-term investment in clinical trials if the UK is to leave the EU’s regulatory environment, with the MHRA (potentially) charged with setting up a new stand-alone system.
Since that has happened, Brook said the level of engagement and focus has “just been transformed”.
“We could have done this without Brexit… but it has been a catalyst and has turbocharged that whole process. For the first time in my many years in clinical research, I’m incredibly positive about the opportunities within the UK.”
Among the concrete actions taken since the Brexit referendum nearly three years ago is the creation of the UK Life Science Sector Deal. First launched in December 2017, this has seen additional investment in fields such as genomics and digital technology in the NHS, plus efforts to clear the path to faster adoption of medicines and other health technologies by the NHS.
Perhaps most important has been the new determination to overcome the institutional boundaries within the NHS and government agencies to cut red tape and increase the speed of decision-making.
NIHR
While initiatives such as the Life Science Sector Deal are broad and ambitious, it’ll take many years for these strategic efforts to pay off. The credit for the transformation in UK clinical trials can be traced most directly to the National Institute for Health Research (NIHR), which was first set up in 2006.
It is the largest national clinical research funder in Europe with a budget of over £1bn. Jonathan Sheffield has been chief executive officer of the NIHR’s Clinical Research Network (CRN) since 2010, and has helped spearhead a major organisational and cultural change in UK clinical research.
Jonathan and his team at the NIHR have created a long-term vision for UK research, and have tackled red tape, roadblocks and a culture gap between the pharma industry and the NHS and academic researchers. A 12-point action plan was drawn up by NHS England and the NIHR in late 2017, targeting specific issues such as better management of ‘excess treatment costs’ (where NHS Trusts charge back costs to trial sponsors) and eliminating delays to confirming multi-site trials.
These sustained efforts have helped turn the UK from an underperformer into a leader in clinical trials in Europe, although there remains more to be done in making the NHS more ready to take on commercially funded research.
The transformation already achieved has been startling: the most recent full year data (from 2017) shows the UK outperforming every major European country in the number of patients recruited, and it is also frequently in the top three regions in terms of start-up timelines.
“Without the NIHR, the UK wouldn’t be one of the leading research bases in Europe and the world today, and we [IQVIA] would not have the significant presence we do now in the UK,” says James Brook.
He said it remains a frustration that international perceptions of UK clinical research haven’t kept pace with that change in performance on the ground.
“I’d really like to dispel the idea that research in the UK is hard. That’s not the case any longer, and that’s very much down to the work that Jonathan and this team has been doing… and in the last few years it’s just taken off.”
Jonathan Sheffield said: “When I joined the NIHR in 2010, only 9,000 patients were recruited into commercial clinical research studies in the UK. But by 2017 we’d recruited over 50,000.”
He said big pharma companies have been pleasantly surprised at the UK’s performance on trial recruitment.
“One company looked at our data and found we were 100 days quicker than France, Germany, Spain and Italy. Those are our main European competitors on delivery, so I think that shows our focus on fast start-up times is paying off.”
This success is based on some detailed troubleshooting in the existing approval mechanisms, resulting in a re-engineering of ethics and research approvals by the Health Research Authority (HRA).
Brexit
As PME went to press, the UK was inching ever closer to 29 March and the threat of a no-deal Brexit (although a postponement of this date looks increasingly likely).
While the government, the MHRA, UK pharma and all the stakeholders have made preparations for this eventuality, all are hoping that a no-deal scenario can be avoided. UK pharma’s ABPI has made it plain that it wants as close alignment with Europe and the EMA as possible after Brexit, and sees virtually no advantages of following an independent path.
While this political decision is out of the hands of the NHS, NIHR and UK clinical trial stakeholders like IQVIA, they are forced to focus on the positive – and pour all their efforts into maximising all the other strengths of the UK environment.
Key areas to watch for the future of UK clinical research
Genomics
Genomics England and its 100,000 Genomes project has helped put the UK at the forefront of genomics. The project is now entering its next phase, where insights from genomic mapping are to be integrated into routine NHS care. The organisation
is also extending its alliances with research-based companies to tap into its genomics database, probably the richest in the world, to help develop new drugs faster and more efficiently.
“This is a game changer,” said James Brook. “It will revolutionise the speed at which identifiers of drug response will come, reducing the cost of clinical research and in turn reducing the cost of the treatment in the long term.“
Joanne Hackett, Genomic England’s chief commercial officer says genomics is “an international scientific endeavour” and that accordingly her organisation’s perspective will be global in order to truly harness the value of the cutting-edge research.
Genomics England recently signed a £20m collaboration with IQVIA (under the auspices of the Life Sciences Sector Deal 2) to help bring the vision of UK clinical research and NHS treatment informed by genomic profiling a step closer to reality.
The partnership will aim to enable faster and more efficient drug research, generate more robust evidence to support treatment value, and ultimately provide greater access to personalised medicines.
Interoperability
One of the big complaints levelled at the NHS is that IT systems at different local Trusts can’t communicate – the issue of ‘interoperability’. To address this, Theresa Allen, the chief executive of the Health Research Authority (HRA) is spearheading efforts to bring interoperability to the NHS, breaking down barriers between Trusts to allow data to be collected and collated more easily.
A unified health system
The promise of the NHS is that it has a single, integrated national system. Unlike systems such
as the US where data is owned by many different insurance companies, the single NHS system has the potential to be one of the most valuable clinical and ‘big data’ data bases in the world. A new digitally focused organisation, NHSX, has just been launched to help break down the many barriers to data-sharing within the NHS to help make this vision a reality.
The win-win: commercial studies benefit the NHS
The funds from commercial sponsors paid to the NHS goes back into the individual institutions and the money is invested back in to patient care.
Around a third of this revenue goes into the NHS Trust’s bottom line, another third goes to the R&D department to support its operations and development, and the final tranche goes back to the clinical teams involved in research, funding their education and training and future development in research and clinical care.
Despite high levels of trial participation, James Brook said the NHS must still be persuaded to build proper structures around conducting commercial research, as it still viewed by some NHS Trusts as a ‘side-line’ activity.
Jonathan Sheffield pointed to the many studies that show participating in research is beneficial for healthcare professionals and their patients – but more still needs to be done to bring about a change in culture.
A digital gateway to clinical trial participation This year sees the launch of the NHS app, which will provide a convenient digital gateway for all patient interactions with the health service. There are plans to include a research button in the app, leading people directly to the UK clinical trials gateway – providing a trusted digital portal for millions of people who are potentially eligible to take part in clinical research.
Patient engagement
The NIHR’s own studies has found that most patients are willing to take part in research, and trust the NHS to take care of their data – but they also want to know that their data is being put to good use.
Last year 725,000 people took part in clinical studies across the country, and the NIHR will now ensure they receive an update thanking them for taking part at the end of a three-year period and informing them about outcomes from the study. This system will depend on their NHS number, a unique identifier that is assigned to all NHS- registered patients.
The Northern Powerhouse
Patient participation in research is unevenly distributed around the country, so the NIHR is working to give people a chance to take part in a trial regardless of where they live. The NIHR is now working with commercial partners to introduce enhanced systems to accelerate trial start-up,
and patient identification systems to enable more patients in urban centres of Northern England like Manchester, Sheffield and Leeds to take part in research.
IQVIA is investing up to £24m investment over five years on growing its UK clinical trials network to support this ‘Northern Powerhouse’ vision. This involves opening a fourth UK ‘Prime Site’ clinical research location, which will expand clinical trial coverage significantly across the region and to use novel data-enabled design in clinical trials and real-world evidence studies.
Uptake of new medicines
The perennial complaint of the global pharma industry has been that while the UK might be a good location to conduct research, its NHS has remained a slow adopter of the resulting new medicines.
NHS England is now the dominant market access gatekeeper in the all-important specialised medicines field. It has now taken on a tough negotiating stance with pharma on prices, but has also introduced new flexibilities and negotiations so that the best medicines with cost- effectiveness mechanisms attached can make it on to the market early – agreements on the two CAR-T drugs, Novartis’ Kymriah and Gilead’s Yescarta providing an encouraging sign. This uptake question will also be an important factor influencing pharma investment in UK trials in the long term, whatever happens with Brexit.