Government update on the Clinical Research Vision: More needed to go beyond recovery?

As a research funder and an advocate for cancer patients, Cancer Research UK (CRUK) has a strong interest in ensuring that clinical research has the conditions to thrive.

To help achieve this, our policy team has been working closely with teams across the organisation to help raise the profile of clinical research within Government. And, helped by the remarkable achievements of those delivering clinical trials during the pandemic, it has become a key priority for the Government – with strong representation in multiple Government strategies.

In March 2021, the Government published a 10-year, UK-wide vision exclusively focused on the Future of Clinical Trial Delivery. The vision contained a welcome recognition that clinical research is critical to driving improvements in healthcare, and identified five key goals:

• Clinical research to be embedded in the NHS
• More patient-centred research
• Streamlined, efficient and innovative clinical research
• Research that is enabled by data and digital tools
• A sustainable and supported workforce

However, without detailed, practicable and well-coordinated plans for implementation, visions often fail to make the jump from well-intentioned rhetoric to transformative impact. The first instalment of such a plan for the clinical research vision was published last June. It covered the first year of the vision, affording the Government with a window to lift its gaze and set its sights for the longer term.

Now, we welcome the product of this: The 2022-25 Implementation Plan. The plan gives an indication of how some of the £5bn allocated to health research in the latest Spending Review will be spent. For example, the plan mentions £150m of dedicated funding from the National Institute for Health and Care Research (NIHR).

Overall, we are supportive of the activities included and hope they will go some way to delivering a stronger clinical research environment. The activities align well with policy recommendations we made in our recent Creating Time for Research and Beyond Recovery reports. Our recommendations were informed by engagement with patients, researchers and other medical research charities. And so, we are pleased to see their voices reflected in the announcement. For instance, the plan contains activities that will help:

• Bolster the capacity of the clinical research system and support a sustainable workforce.
• Make research an intrinsic part of clinical care so that patients can access new and improved treatments and technologies.
• Make it easier for patients, service users and the public to access research of relevance to them.
• Help research to happen more quickly and predictably, including a more flexible regulatory model.
• Use data and digital tools to increase the resilience and sustainability of the healthcare system and reduce the burden on the NHS workforce.

It is particularly great to see the Government taking steps to address disparities in access to clinical trials. Such inequalities likely exacerbate health inequalities in the UK. However, we currently lack the data to fully understand the scale of this issue. This makes the plans for NIHR and NHS Digital to develop mechanisms that help monitor the diversity of people participating in NIHR CRN portfolio studies a very welcome first step.

Testing times

Unfortunately, the plan has arrived during a testing period for clinical research and the NHS more broadly. This is despite targeted efforts by NIHR, through Research Reset, to restore the portfolio of clinical studies impacted by COVID-19. The challenges encountered during this process have shone a light on the underlying system level issues.

With the UK’s recovery considerably outpaced by countries such as Spain and Italy, we have concerns that, despite best efforts, the current plans will not be enough to overcome a strong undercurrent. For instance, there are numerous underlying issues that have not yet been addressed by either plan.

This includes a recognition of the national health priorities the Government has already set when considering the on-going management and recovery of the UK’s trial portfolio. These include cancer, mental health, cardiovascular disease and dementia. When setting priorities, we would also like to see consideration given to the UK’s research strengths in discovery science and complex clinical trials.

And while slow study set-up has rightfully been prioritised in the plan, the benefits being delivered by more efficient regulatory decision-making are being diluted by bureaucratic and risk averse local processes when approving and setting up clinical studies. Concerted efforts are needed from R&D and research teams to radically overhaul how this is done. This will help ensure that the UK is an attractive place to run trials so that our patients are able to access novel therapies at the earliest opportunity. We’d like to see stronger commitments in this critical area.

As well as broadening the vision’s scope, it will also be important for the Government to build directly on the plan’s foundations. This includes quickly following through on the commitment to share additional information on the vision’s dedicated website. Priorities for further detail should include information about accountability, funding and timelines. Success measures for the vision are also due later this year and these will be critical in shaping the future of this programme. Whilst the current vision calls for a democratisation of research – more research available to more patients in more places – we would call for greater emphasis on the quality of the research being conducted, and the impact this might have on patients and the public.

Without addressing the above, the vision will struggle to transition from well-intentioned rhetoric to transformative impact. We therefore welcome the plan’s commitment to keep the specifics of these plans under review.

In collaboration with many others across the organisation, we will continue to monitor and support UK clinical research to go beyond recovery. This will involve proactively engaging with the Government and others to make sure the voices of researchers, patients and medical research charities are heard.

Author:
Joe Kiely is a policy advisor in the policy development department of Cancer Research UK