The benefits of clinical research

You may have noticed that there have been a number of recent articles in the press on the challenges and opportunities for clinical research in the UK recently.

Ahead of a Government review on how to improve industry partnerships to bring cutting edge science to the frontline of NHS care, our Acting Director of Research and Innovation at GOSH, Dr Jenny Rivers , explores the challenges and opportunities for locking research into everyday NHS clinical care:

At GOSH, we are an expert in delivering clinical trials, in our NIHR-funded Clinical Research Facility, embedded throughout our clinics and wards, and in collaboration with other hospitals in the UK and across the world. But this doesn’t mean it is always simple or easy to deliver that research. What are some of the challenges we face? And what are the opportunities?

Trusts across the UK are currently under unprecedented pressure

The drive to get through waiting lists and clinical time is more acute than ever – but research is clinical care and our approach must focus on how we can weave these together for patient benefit and not see them as competing priorities.

Patients seen at hospitals that carry out research, not just clinical trials, do better even when they are not directly involved in the research so we must find a way to make this a reality.

Improved hospital governance

For clinical trials to be carried out in a robust and trusted way, there is a lot of due process that must be carried out – we know this is crucial and funding for research must cover the full breadth of these processes and not just what organisations see as ‘The Research’.

Covid showed us that, when funded properly, research set-up can be carried out quickly and effectively (RECOVERY was set up for children in under a week) so how can we best learn from this for business-as-usual?

·        The structures and systems need to focus on what they do best, avoiding duplication and encouraging trust and collaboration.

·        Good accounting and financial management should be in place to ensure that activity is fully costed and all income streams can be tracked to point of delivery.

·        Research funding should be separated out and should not be used to subsidise services.

With investment and support from the NIHR and GOSH Charity, we have assessed where to make the most impact at GOSH with scarce resources. We’ve streamlined our processes since 2020 for Research and Development study set up and governance, including through the use of link co-ordinators with theatres and radiology, and transition teams to take clinical research into wards and clinics.

Lack of protected time

We recognise that there are multiple pressures that can make it difficult to find the time to manage research set-up or governance but we need to move to a place where research is part of every role, not as an ‘add-on’ to an already full workload.

Protecting capacity is essential to ensure that the system can activate as and when needed. This is particularly true for support systems relevant to trials, such as pharmacy, imaging, and legal services, which can often limit the rapid establishment of trials due to capacity constraints.

We are working towards this at GOSH but the first step is to recognise the extreme pressures the NHS is currently acting in - resilience, challenges to recruit and retain expert staff and strikes, to name a few.

Utilising strategic relationships

Research-active hospitals have strategic relationships with key players and can help build holistic partnerships across the life sciences. At Specialist Hospitals like GOSH, our clinicians and researchers are regularly approached by companies who want to work with them, we have the research infrastructure, protocols and regulatory processes ready to go and access to large numbers of patients who could benefit. With proper funding and collaboration across the system to improve efficiencies we could be utilised more. For example, developing appropriate clinical trial protocols, identification of the most suitable trial sites and effective navigation of required regulatory processes.

We do not simply deliver contract research for industry, neither can we just adjust adult doses for children and expect the same results. Research active hospitals can be involved right through the pipeline. At GOSH for example, we can involve patient groups and the public to advise on a proposed research project. The NIHR GOSH Biomedical Research Centre and our relationships with other children’s hospitals in the UK and abroad allow us to deliver translational research designed around the needs of children, and to maximise benefits for them.

But we could do more – ‘pre-planning’ work across the system, including regulators, sponsors, funders and other partners could be helpful in ensuring a smoother experience of dealing with the NHS for industry – this would be particularly important for biotech companies and those with less experience of working in the UK health system.  

Perception that things are still stuck isn’t necessarily true

The national and local picture is that things are getting better – The reset process and latest data indicate we’ve turned a corner and are seeing big improvements.

For example, the current national recruitment is ~74,000 patients per month, which is over 10,000 more than the pre-pandemic monthly average of c. 61,000, while ~31% trials on portfolio are commercial, which is similar to pre-pandemic levels.

There is no doubt that there are gains to be made for the health of our population, in our case, children, and the adults they will become if we can unlock the potential of clinical research.

We will need to work together to get there, but it is possible.