Lord James O’Shaughnessy, who created an in-depth report on the UK’s commercial clinical trial landscape after a significant decrease in trial initiation, hopes that the UK’s clinical trial activity will have doubled exponentially in five years.

In his keynote speech at the Arena International Outsourcing in Clinical Trials UK and Ireland 2023 conference in London on 6 September, O’Shaughnessy spoke about how his report will shape the reform of commercial clinical trials in the UK after a 44% reduction in commercial clinical trial initiation in the past five years, dropping from 4th to 10th as global contributors.

During his presentation, O’Shaughnessy spoke about how primary care can assist in the increase in clinical trials due to their desire to conduct more research. A report used during O’Shaughnessy’s review, compiled by the Royal College of Physicians found that 55% of clinicians want to be involved in research but that 53% cited time constraint as the biggest barrier.

The report has highlighted a number of points in which the country could improve commercial clinical trial operations and make the UK a more viable place for pharma to conduct clinical research in the commercial field.

In an exclusive interview with the Clinical Trials Arena, O’Shaughnessy spoke about the feedback from his report, things he wishes he had maybe done differently and what the future could look like for the UK commercial clinical trial industry.

Abigail Beaney: How do you hope that this report can be used to future-proof the UK and ensure that commercial trials are really the backbone of research within the country?

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Lord James O’Shaughnessy: I think the conclusion I had from the review is, first of all, commercial clinical trials are really important. And although they are only a relatively small part of our total clinical trial activity, they have an outsized importance for patients, for industry, and for the NHS as well so it’s a really important policy focus, that is the first thing. Second is we have to be realistic, despite having in a way a very good pandemic in clinical research, other trials were put on pause or didn’t happen at all. And we need to rejuvenate the whole industry so you’ve got to be honest about some of the problems we’re facing. There is slow setup types and so on. But then the review is all about having practical recommendations to the government and all the other actors who need to make stuff happen like the NHS, to make a difference in the short term – in the next two to five years.

AB: In regards to the timing for GPs with the hope that they will become a vital part of clinical research. What are your thoughts or reflections on that looking back on your report? You mentioned that you potentially thought about putting that protected time in there for GPs but did not?

JO: It’s a really difficult one because obviously, we don’t have enough staff at the moment. This government and any government would want to be recruiting more staff so that is a challenge. Therefore, saying we’re going to magically save 5% of his time, or whatever it is, to be set aside without some other big change, I just think is potentially unrealistic. Albeit, that is something we have to grapple with. So I think the answer is through a number of other means, like financial incentives, professional incentives, the better use of technology, which of course, can lead to productivity gains, which creates more time, that’s how we can carve out time in the short term.

AB: You also spoke about looking at research becoming more disease-focused rather than location focussed by brining the research to the patients rather than the patients to the research. How should work for clinicians as well as patients? 

JO: Obviously, the big clinical trials sites are multi-specialty and they focus on a number of diseases. But, a lot of our infrastructure is based around creating capacity within certain hospitals, whether or not those hospitals are seeing a lot of a certain type of disease area, or, frankly, whether or not they’re high performing. The idea of this change is we create a slightly different way, a fundamentally different way actually of doing it, which is focused on disease areas, which are of importance to us from a health point of view, dementia being a good example, as well as being we have life science missions, and providing the quickest route through clinical trial approval and setup anywhere in the world, in the disease areas or therapeutic modalities that matter to us.

AB: Questions have been asked about how these new models can collaborate with pharma overall. What are your hopes about how the NHS will continue to work with pharma companies and ensure that the NHS is contributing to some of these pivotal clinical trials?

JO: This point about collaborating with industry, pharma, biotech, and others is really important because there is a risk that the NHS and the academic world just talk to each other and we don’t draw on all that expertise that sits in industry. So if we are to rejuvenate the commercial clinical trial sector, then we need to, we have to listen to the customer and the customer is industry and of course, they will have various demands, but they also have lots of expertise. And so, co-producing these reforms is going to be really important. During the review, I tried to listen to dozens and dozens of people from industry from different perspectives, as well as from the NHS, government, academia and so on and hopefully that is reflected in the report, but it needs to continue.

AB: You said at the start of your keynote speech that people came up to you and asked, ‘why can’t we go back to five years ago?’ What are your hopes for five years from now?

JO: We will have doubled and then doubled again, our commercial clinical trial activity, and there’s no reason we can’t do that.