top of page

UK govt promises national clinical trial ‘directory’ – but will it deliver?

The UK government today announced that it will set up a national clinical trial ‘directory’ to provide continuously updated information on trials being conducted in the country. A detailed work plan will be made public in autumn 2023.


The ‘Lord O’Shaughnessy review into commercial clinical trials in the UK,’ a report released today, noted that there is no single directory of clinical trials in the UK, and recommended that:


“MHRA, HRA, NIHR and its equivalent organisations across the UK should collect, consolidate and publish national monthly returns on all the clinical trials activity that is happening in the NHS, and NHS bodies and commercial sponsors should publish numbers of patients in trials on a monthly basis.”


“Building on near real-time activity and performance generated according to the above recommendation, the UK governments should create a UK phase 1 to 4 clinical trial directory – called ‘clinicaltrials.gov.uk’ – to create a single source of activity for patients, clinicians, researchers and potential trial sponsors.”


Currently, clinical trials run in the UK are either registered on the American ClinicalTrials.gov registry or on the London-based ISRCTN registry. Both registries are official data contributors to the global WHO trial registry network.


The fragmentation of UK trials between two separate registries makes it difficult to obtain a comprehensive overview of all trials run in the county. Data on all UK ethics approvals for clinical trials are already being centrally collected by the Health Research Authority, but those data only provide a one-time snapshot of planned trials.


Government pledges £81 million


In its official response to the report, the UK government stated that:


“The government… accepts both recommendations, with delivery to begin immediately, and backed by £81 million over 3 years, provided by the NIHR. This will benefit all NIHR Clinical Research Network (CRN) portfolio research from all funding sources, and ensure that transparency and accessibility for patients, clinicians and research funders is enhanced.”


The £81 million pledge form part of a wider £650 million life sciences funding package announced today.


It is unclear whether or not the new ‘directory’ is intended to become an official WHO trial registry, or a national information hub that is separate from established registries.


Promises made, promises broken?


Till Bruckner, founder of TranspariMED, said:


“It would be extremely useful for many stakeholders to have a continuously updated overview of which UK trials are ongoing and how many patients have been recruited into each of them.”


“However, this government has a history of making bold announcements about improving clinical trials and then failing to deliver. For example, the government’s #MakeItPublic strategy announced long ago that all clinical trials would be pre-registered directly by the Health Research Authority, but currently 8% of UK clinical trials are still not being pre-registered because the government has so far failed to deliver on that simple pledge.”


“Providing monthly updates on the recruitment figures for each and every UK clinical trial would be far more challenging – and far more expensive – to implement.”


“TranspariMED hopes that the government will use this latest initiative to finally, and fully, deliver on the transparency pledges set out in the #MakeItPublic strategy and in the government’s UK National Action Plan for Open Government 2021-2023.”


The Lord O’Shaughnessy review


The Lord O’Shaughnessy review’s mandate was to produce recommendations for making the UK a more attractive destination for clinical trials run by industry. It sets out an overarching target of increasing recruitment to commercial trials four-fold by 2027.


The review’s analysis and recommendations focus on the concerns of industry rather than on those of non-commercial researchers or patients:


“There does not seem to exist a consolidated real-time view about which clinical trial sites are carrying out which kinds of trials for what number of patients, and whether they are performing against the targets agreed with their commercial and other partners. If this is true of research into medicines it is even more true of research into devices, diagnostics and the rapidly growing digital health sector.”


“It is not acceptable that we are spending hundreds of millions of pounds each year and cannot properly account for whether it is delivering excellence or not.”


“The lack of good-quality data has 3 negative consequences. First, it means that very little performance management is possible by the funders of the research infrastructure, such as NIHR. As a result, underperformance goes unchallenged and over-performance unrewarded. Second, it means that industry has no way of seeing which trial sites are performing well or have capacity, and which should be avoided. Too often they are selecting sites in the dark, especially small biotech or healthtech companies with less experience of working in the UK or outsourcing these decisions to clinical research organisations. Third, it means that clinicians, patients and the public are not able to find out which trials are recruiting in their area or virtually that might be relevant to them.”


“The lack of a single source of planned and ongoing trials leads to inequity of information, with senior clinical academics are more likely to refer patients to trials that they are aware of through their research practice and missed recruitment.”


“A clinical trial directory would help trial recruitment if this directory maintained up-to-date information for phase 1 to 4 trials in the UK, including status of trial (open, closed, recruiting, and so on) to enable capacity planning.”


Sources:

Bình luận


Subscribe
Subscribe
Recent Posts
bottom of page