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James O’Shaughnessy is clear about the rationale for making new healthcare treatments easy to trial in the UK. “Without research, there are no improvements in care,” he says. Clinical trials bring early access to pioneering treatments. Then there’s the investment in local research facilities and big opportunities for the academic and industrial research community.

O’Shaughnessy should know. As the chair of the UK Government’s review of commercial clinical trials, he has studied the landscape of life sciences research in detail. His report has been hugely influential in the UK regaining its position as a world leader in hosting clinical trials.

Pharmaceutical giant Moderna, for instance, has begun a £1 billion investment in UK-based operations. “When we started to look globally at where we might want to set up additional investment, the UK stuck out very prominently,” says Melanie Ivarsson, Chief Development Officer at Moderna. “There are many great locations in the world for running clinical trials, but the UK is a leader because of its progressive regulator,” she adds. “All that, combined with an extraordinary willingness and enthusiasm to invest in the life sciences sector, meant that the UK was an obvious choice.”

It’s a welcome turnaround, because the UK’s hold on this sector had started to slip for a number of reasons. One was that other countries made a concerted effort to gain
a slice of the pie. “It is a competitive field and other countries decided to go after this area and have done really well,” O’Shaughnessy says.

Another is that, while the covid-19 pandemic demonstrated the UK’s skills in this area, it also exposed the limits of its infrastructure. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) was the first regulatory body in the world to approve a covid-19 vaccine.

But that rapid breakthrough came at a cost: delays to other, less urgent trial approvals. “By the end of June 2023, we had a significant number of clinical trials [awaiting approval],” says Andrea Manfrin, Deputy Director of Clinical Investigations and Trials at the MHRA. The statutory timeline for the initial review was 30 days but some trials were waiting 150 days.

Aware that something was awry, in February 2023 the UK Government commissioned O’Shaughnessy to review the sector. Change has come quickly since the publication of his findings in May.

During the summer of 2023, the MHRA made the decision to redistribute its staff and apply a different approach to the assessment of clinical trials. Where every trial had been approached and assessed in the same way, resources are now allocated depending on their specific risks.

So a trial that is deemed high risk, receives rigorous assessment to ensure the safety of the patient. But one that is lower risk—using known medication in a new way, for example—requires less assessment and potentially can be approved more quickly. “It’s a balanced effort, according to the perceived risks and benefits,” Manfrin says.

The outcome has been hugely important and since March 2023, the MHRA has been meeting and even surpassing its statutory timelines for clinical trial applications.
But it’s not just about efficient assessment of clinical trial applications. The lessons learned from O’Shaughnessy’s report are now being used to foster even more innovation, such as having a larger and more diverse set of people enrolled in clinical trials, and digital health technologies, like smartphone apps, that make it easier to take part.

O’Shaughnessy is also excited about the potential of artificial intelligence. “We can use this to look for the kind of patients that would be suitable for trials,” he says. What’s more, AI can comb through the National Health Service’s (NHS) datasets to find clues that help speed diagnosis and treatments.

All of this has to prioritise safety, transparency and ethics, O’Shaughnessy points out. “Understandably, people care about how their data is used,” he says. “They want to know it’s not just secure, but that how it’s being used aligns with the values of the NHS.” And using that data in full compliance with privacy law is vital, of course.

The NHS is also a key enabler for clinical trials, Ivarsson reckons. “The NHS is incredibly unique – and very important to us,” she says. That’s because of its “joined-up” healthcare, where pharmaceutical companies or academic researchers can conduct trials using patients drawn from across the whole country. Also helpful is the UK’s natural diversity: the NHS is a source of trial patients that reflect all of the various groups of people that will ultimately use a new medicine.

Add that to the UK’s openness to innovation and the country is once again fertile ground for pharmaceutical research. That’s why Moderna is building a new research facility in Harwell, Oxfordshire. There will be offices and laboratories for researching biomarkers – biological indicators that can help diagnose disease – and a manufacturing facility. “It will produce about 100 million doses of vaccines a year and that could be increased to 250 million in a pandemic,” Ivarsson says. Moderna is also investing in research and development personnel, including academic fellowships and PhD studentships, across the UK.

The MHRA is working hard to bring in further innovation to build on this success. “We are aiming to be an agile regulator, where patient safety is paramount but we are still enabling new medication to be available in a fast and safe way,” says Manfrin.

O’Shaughnessy agrees that this is entirely possible: leadership with covid was just a glimpse of what the UK can achieve. The plan now is to double the number of UK-based clinical trials by 2027 and, beyond that, to establish the UK as a science and technology superpower.

“Our scientific strengths and our trial strengths meant that we were able to directly contribute to saving tens of thousands of lives,” he says. “Now we can rediscover that energy in a post-pandemic world where we’re not just focusing on one disease, but on the whole range.”

Listen to the full interviews with James O’Shaughnessy, Andrea Manfrin and Melanie Ivarsson at ���ӽ紫ý Podcasts

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