In October 2022, the Association for the British Pharmaceutical Industry reported that the number of clinical trials run by pharmaceutical companies in the UK had declined over recent years.
This wasn’t a case of industry just complaining about how hard it is to run their business. More importantly, they explained the impact this is having on the NHS and all of us as patients. And it’s not good news.
Clinical trials are research studies that compare two or more treatments or methods of care. The UK Government or charities fund most of the clinical trials in the UK. But pharmaceutical companies run about a quarter of clinical trials. Companies run these trials to produce evidence about new treatments developed by the companies. The companies can then use this evidence to get a licence to market the treatment, and to apply for the treatment to be used in the NHS. So clearly a decline in these clinical trials is bad news for companies and for the UK economy.
Smaller numbers of trials also mean that it might take longer for new treatments to be available for patients in the NHS. In some cases, patients with diseases that can’t currently be treated might not have the opportunity to take part in a trial of a new treatment. Of course, there’s no guarantee that a patient would get the new treatment or that it would work – that’s what testing is all about.
But patients often want to be involved in improving the situation for people like them, even if it may not help themselves. So, having fewer industry clinical trials is bad news for patients now and in the future. It’s also bad news for doctors who don’t get the opportunity to learn about new treatments as early as possible.
Perhaps surprisingly though, having fewer industry clinical trials is bad news for the NHS too. Industry clinical trials save the NHS money, because companies provide the treatments free, and the companies pay for the time of all the staff involved. That income helps the NHS to support other research.
Getting things back on track
That all sounds like a lot of bad news! But lots of the organisations that help make research happen in the NHS, are working hard together to get things back on track.
The Health Research Authority is playing a key part in that work, as part of our strategy to accelerate research: making the UK the easiest place in the world to do research that people can trust, so that research findings improve care faster. That’s why it’s good news that the government has set up an independent review of industry clinical trials. The review will be led by Lord James O’Shaughnessy. His team have been busy listening to everyone involved, to find out what’s already underway and consider what more we can all do.
So, what’s already happening? 'Saving and improving lives: the future of UK clinical research delivery' was published in March 2021 to set out the UK’s vision. More details are set out in the current 2022 to 2025 implementation plan.
This describes a co-ordinated and collaborative programme of work to ensure the Recovery, Resilience and Growth of UK clinical research delivery.
There are seven areas of action:
- improving the speed and efficiency of study set-up
- building upon digital platforms to deliver clinical research
- increasing the use of innovative research designs
- improving visibility and making research delivery matter to the NHS
- making research more diverse and more relevant to the whole UK
- strengthening public, patient and service user involvement in research
- aligning our research programmes and processes with the needs of the UK health and care systems
As part of the programme, the HRA has already worked with the Medicines and Healthcare products Regulatory Agency to create a combined review, reducing the paperwork and timelines for researchers to earn the approvals they need to go ahead. We’ve also set up a fast-track ethics review option, offering the same robust review with a shorter timeline. Eligible trials can also go to the front of the queue for set-up in the NHS.
Working in partnership to make improvements
We are working to make sure that people can trust the research that goes ahead. We’ve worked with partners to make a shared commitment to embed public involvement in research so that we do research with and for people, not about them. And we’ve worked in partnership with public contributors to define six hallmarks of people-centred clinical research – setting out what putting people first in research looks like in practice. The planned update to the law governing clinical trials in the UK will also be an opportunity to clearly signal what research that people can trust should look like.
We will work in partnership to develop guidance to support researchers that is flexible and reflects the scale and nature of different clinical trials.
Now we are working with NHS England and others to make big changes to the way companies agree payments with NHS organisations for research. At the moment, all the organisations involved spend a lot of time negotiating. This not only wastes time, it means the NHS doesn’t get as much research done. So, it loses thousands of pounds while negotiating over small amounts. We’re also reviewing the templates for contracts between companies and NHS organisations to make sure they help people do research in new and people-centred ways. With colleagues at Cancer Research UK and the Experimental Cancer Medicines Centre Network we’ll be using these new processes and testing new ways to get research up and running in hospitals quicker.
Together with our colleagues across the UK, we are changing policies and processes so that we have a truly UK-wide approval service. We’re planning to build all of this into new online systems, to make sure that the right people have the right information at the right time to set up and run trials efficiently.
This is just a sample of the things that we’re doing across the UK, but we really need to make sure we are putting our energies in the most useful things. The new independent review will really help us all to take stock and learn together.
Director of Approvals Service, Health Research Authority
Dr Janet Messer