05/10/2025
If patients only knew how bureaucracy obstructs their involvement in research and clinical trials
Masud Husain
Brain, Volume 148, Issue 10, October 2025, Pages 3423–3424, https://doi.org/10.1093/brain/awaf309
One of the major frustrations, for researchers and patients alike, is the inordinate time it now takes for people to have an opportunity to participate in new studies. This includes testing of new drugs. In several areas of medicine, novel therapeutics are the last hope for sufferers. In cancer, their availability can be time-critical; lives might be saved if a new treatment proves to be effective. In some brain disorders, a new drug might prevent accrual of irreversible disability which is a costly burden for patients, their families and society.
In the UK, the situation has become particularly absurd. The last set of published data, which is already out of date, showed that in 2021 the median time between a clinical trial application being submitted to the regulator and the first dose in a patient was 271 days for some commercial trials. The corresponding time in the USA was 159 days. Year-on-year the time taken to commence a trial has continued to increase across the world.1
Why is this the case? The UK government sought to find the answer and commissioned a review conducted by James O’Shaughnessy which in 2023 concluded that ‘clinical trial set-up and approval processes in the UK are slow and bureaucratic’.2 It dryly observed that there is a ‘lack of accountability at every level for underperformance in clinical trials’. In response to the recommendations of the review, the Department of Health & Social Care this year published its target to cut the time to trial set-up to 150 days.3 The UK government’s focus seems specifically on ‘cutting the time taken between regulatory approval to … first participants recruited’.
Clinical researchers will be supportive of this initiative but will also continue to be frustrated. They will be shocked by the lack of ambition. They know full well that ‘150 days’ does not actually capture all the time it takes from acquiring funding or Pharma involvement to trial initiation. There is a great deal that goes on before submission to a regulator, so the real time required is far longer. One of the biggest obstacles to getting a trial off the ground in the UK remains obscure to patients—and perhaps even politicians—who are unlikely ever to think of it as a potential problem. This is the relationship between universities and the NHS, each of which has independent regulatory processes for research approval.
Academics, who are usually university employees, are critical for healthcare research.4 They are the Principal Investigators (P*s) who are driving innovation and leading clinical studies. They are also the people that pharmaceutical companies approach to run new trials. But the locations at which their patient-facing research is performed is most often in hospitals, not universities. Many clinical P*s work across both sectors. However, the administrations running universities and hospitals are not joined up. They work independently. Even though some institutions pretend to have joint research offices, the motivations of hospitals and universities are not aligned.
One of the goals of a university is to maximize grant income while ensuring that research is conducted safely and with low legal risk. For hospitals, the priority is service delivery and cutting waiting list times. As O’Shaughnessy spotted, the incentives for them to perform research are, on face value, extremely low.2 Instead, the imperative is mitigation of litigation risks. Nevertheless, with increasing pressure to recoup costs, hospitals are scrutinizing whether any NHS infrastructure or personnel are involved in a study so that they claim some of the research costs. There is an endemic culture of hospitals considering themselves to be ‘possessors’ of patients who are seen in their clinics.
This situation means that there are two sets of local administrations—in the NHS and in the university—with oversight over any single research study, in addition to an independent research ethics committee and the NHS Health Research Authority (HRA). Such multiplicity of governance at any one site constitutes a major obstacle to getting studies off the ground in timely fashion.
A second key problem is with research conducted across several different sites across the country. Because each university and NHS Trust operates independently, one study is often scrutinized several times over at different sites, either financially or for governance. Recursive reviews of research protocols by R&D departments; legal scrutiny of contracts; material or data transfer agreements between universities and/or NHS Trusts; calculation of overheads to be charged; costings for each university and hospital; university research service approvals; obtaining honorary contracts for non-clinical researchers; and many other procedures can take months, if not years. Shockingly, some studies in the UK never start because Pharma isn’t prepared to hang around for this kind of nonsense. Who can blame them? Intriguingly, neither universities nor hospitals seem to care when this happens, although patients certainly would—if they ever knew. No one is held accountable for these opportunity costs.
This is partly because the governance and contract systems at universities and NHS Trusts have turned into an infuriating labyrinth to navigate. They have a chokehold on research, even before ethical review or the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approval. This asphyxiation deters not only pharmaceutical companies but also P*s from even contemplating new clinical studies. Who can face the formidable ‘mountain of small things’ that stubbornly stands in the way of progress?5 Worryingly, many P*s are now relieved when they are unsuccessful at securing a grant that involves research across universities and hospitals. This is because it has simply become too much work to run such studies—work that is completely unnecessary for the safe participation of patients. Even closing a study at the end of its term has, as I found recently, become the provenance of four different groups of administrators, each writing to me for the same details.
In short, we have created a many-headed, lumbering beast that is totally out of control, a leviathan that seems to have not one, but rather several minds of its own. The situation is particularly galling when one considers that much of the funding for clinical research at universities and hospitals comes from government—and the taxpayer.6 These institutions, funded by us, are haggling over money awarded by government to conduct research, each wanting to maintain independent oversight over it. They employ several groups of people to conduct this exercise. Such devolution of responsibility to both university and hospital simply isn’t a cost effective or time efficient way to run research. It also prevents patients from being given rapid opportunities to participate in new studies and treatment trials. It is a madness that simply would not be permitted to exist, let alone thrive, in any leading business organization.
How can we change this system? It seems to me that this can only be through radical structural transformation.7 The solution is actually in clear sight. Let’s insist that there must be a single unified governance system across academic and clinical sites, without any duplication of oversight: just one administrative body which takes responsibility for a research study, with one single contract for its employees. In addition, let’s make it so that approval at one centre also means approval across all such institutions across the country. This is a national health service after all, isn’t it?
The problem is that we can’t trust either universities or NHS Trusts to do this. As we have seen, they have parochial priorities (financial and legal risk mitigation) which mean that they cannot be relied upon to take the obvious initiative which would be in the interests of patients. Instead, this change must be driven by government through its organs: NIHR (National Institute for Health and Care Research) and UKRI (UK Research and Innovation). These organizations make a major contribution to UK healthcare research and could lead the changes required by using their funding leverage.
For NIHR this might be through the BRCs (Biomedical Research Centres) it funds. Although many BRCs state that their university and NHS components work together, this is a pretence. There is no real unification. Accounting, approvals and contracts are all separate. I have first-hand experience because I work in a BRC which straddles two different university departments and two different NHS Trusts, each with it own administrative teams. If the incentives for universities and hospitals were made sufficiently tough, we could potentially get to a streamlined system that cuts out rounds of replication. NIHR needs to insist that centres it supports—BRCs and national networks—will not receive any funding unless they can show that they have one unified administrative body for governance across a university and its partner hospital. The same should apply for UKRI grants.
Regarding multicentre studies, one of the interesting initiatives that the UK is contemplating is to use the NHS app to recruit patients into studies and trials.8 In many ways—and provided digital exclusion can be mitigated—this is an extremely positive step. It might allow patients far more opportunities to be involved in studies and trials across the country. It also has the potential to reduce the culture of ‘possessing patients’ that many NHS Trusts seem to assume, thereby liberating people to make choices that would otherwise not be available to them. What a refreshing change that would be!
The UK Government has announced its ambitions to streamline clinical research. Although several aspects of its proposal are laudable, it is missing one vital part of the problem: the relationship between universities and the NHS. We can’t leave these organizations to come up with the obvious solution. If only we had the nerve to dismantle the multiplicity of administrative bodies that have been created, supposedly to protect patients.
https://academic.oup.com/brain/article/148/10/3423/8272552?login=false
One of the major frustrations, for researchers and patients alike, is the inordinate time it now takes for people to have an opportunity to participate in
