Masud Husain, professor
To revive clinical research in the UK we need to streamline systems and dismantle bureaucracy, writes Masud Husain
Clinical research in the UK is now at a critical point. What used to be a shining example across the world has become slow, ponderous, and inefficient. The number of patients entering clinical trials in the UK fell by 27% from 2018 to 2023 and new industry trials declined 38%.1 Small wonder that pharmaceutical companies, reluctant to embrace a system which they consider “unreliable and unpredictable,” are turning away from the UK.2 Shockingly, some clinical studies, including trials, are failing simply because they never start. Although the UK government plans to introduce new legislation to improve the situation,3 this on its own won’t resolve matters because of the lack of integration between universities and the NHS.
Although several factors have been identified as contributing to poor clinical trial performance in recent reports,12 one issue that has received little attention is the relationship between universities and the NHS. Higher educational institutions are critical for healthcare research.4 They drive innovation and often lead clinical studies. But the locations where these are performed are usually hospitals, not universities. One key structural problem that is an obstacle to research is that the administrations running universities and hospitals work independently, often duplicating approval processes and increasing costs that are ultimately met by the taxpayer, charities, or students’ fees.
A second key structural problem concerns multicentre research. Each university and NHS Trust operates independently, therefore, a study is scrutinised afresh, sometimes several times over at each site. Replication of efforts in reviewing and approving contracts, costs, protocols and agreements as well as many other procedures, such as honorary contracts, can take more than a year. The system has become an exasperating maze to navigate. A formidable “mountain of small things” is obstructing progress.5
What is the solution? There must be a fundamental structural change. We can’t rely on individual universities or NHS trusts alone to conduct clinical research in the national interest because they have their own governance and financial agendas.
First, a radical step forward would be for the government and charities to award research grants only to those institutions that have a genuinely unified administration across academic and clinical sites, with no duplication of oversight. To make a true improvement, research centres need to have one system with integrated accounting, approvals, and contracts. Institutions should have to prove that they undertake all this in a single*,* joint administration which cuts across academia and health providers, with one contract for its employees.
Second, if administration can be conducted by one entity across a university and NHS trust, it should be possible to have one contract for other staff who work across these sectors too. The current system of honorary contracts for researchers in NHS hospitals must be abandoned. Only organisations that can prove that unified contracts are in place for their researchers should be awarded research grants.
A third important change would be that once obtained, approval at one research centre should apply to all other institutions across the country, provided that they too have a single, joint administration overseeing research. This is particularly critical for multicentre intervention studies. A repeated complaint from pharmaceutical companies is that it’s not worth starting a trial in the UK because it costs so much—in time and paperwork—to obtain approvals across sites. We should be able to stop this if we truly have a national health service committed to research and innovation.
But how can such structural changes come about? A very good example is the Athena Swan Charter.6 Originally introduced to improve career structures of women in science, technology, and medicine, it has led to a shift in organisational culture across universities in the way they approach diversity, equity, and inclusion.7 The key incentive was that to apply for research grants it was necessary to provide concrete evidence of commitment and adherence to the charter’s principles. As a result, Athena Swan has brought about fundamental change.
For clinical research grant applications, if the incentives for universities and hospitals were to be made similarly challenging, we could encourage these organisations to streamline systems to cut out replication, reduce administrative costs, and free up clinicians to do research. This is where a national body like the National Institute for Health and Care Research (NIHR) needs to step up and insist on structural change across research centres and the national networks it funds. We don’t need any more reports on why the UK is failing. We just need to get back to doing what we once did well, and that requires the courage to dismantle the costly bureaucracies we have created.8
Footnotes
Competing interests: The author’s research is supported by a Wellcome Trust Discovery Award and by the NIHR Oxford Health Biomedical Research Centre. He has received honorariums from Bial Pharma, Eli Lilly, Otsuka, and Sumitomo.
Provenance and peer review: Not commissioned, not externally peer reviewed.
References
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The Association of the British Pharmaceutical Industry. Getting back on track: Restoring the UK’s global position in industry clinical trials. https://www.abpi.org.uk/publications/getting-back-on-track-restoring-the-uk-s-global-position-in-industry-clinical-trials/
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The Academy of Medical Sciences. Future-proofing UK Health Research: a people-centred, coordinated approach. https://acmedsci.ac.uk/policy/policy-projects/future-proofing-uk-health-research
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