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UK parliament to grill universities over missing clinical trial results

On Tuesday, UK parliament will assess progress in clinical trial reporting by universities and NHS Trusts. The session follows up on parliament’s 2018 enquiry into clinical trial transparency, and will be streamed live from 09:30 onwards.

Update: A transcript of the session is now available online.

Meanwhile, new compliance data shows substantial but uneven progress by non-commercial trial sponsors across the country.

Key takeaways:

  • Parliament will grill medical research institutions that have failed to fix their trial reporting

  • UK regulators will be questioned about their efforts to improve trial reporting.

  • UK universities and NHS Trusts have made strong but uneven progress in trial reporting

  • Most clinical trials of medical devices remain unreported

  • Chair of Committee: "Two-thirds compliance is not enough"

Parliament will grill medical research institutions that have failed to fix their trial reporting

Sinners. Two institutions, Manchester University NHS Foundation Trust (66% of due trials still missing results, 31 trials total) and St George's, University of London (all 11 due trials are missing results) will have to explain their weak performance to parliamentarians.

Winners. On the positive side, two institutions that have significantly improved their performance, University Hospitals of Leicester NHS Trust and Queen Mary University of London, will also be asked to share their perspectives.

UK regulators will be questioned about their efforts to improve trial reporting

Health Research Authority. The national ethics regulator, the Health Research Authority (HRA), will be quizzed about its efforts to draw up a national transparency strategy. In 2018, Parliament recommended that the HRA develop a national clinical trial monitoring system and impose sanctions on trial sponsors that fail to register trials or report their results. Data compiled by TranspariMED shows that the proposed monitoring system would be highly cost-effective. The HRA has put a lot of effort into developing a national strategy, and recently ran a monitoring pilot. However, the HRA has so far appeared to be resistant to imposing sanctions.

MHRA. The national medicines regulator MHRA will also make an appearance. The MHRA has made rapid progress on improving the accuracy of trial registry entries – a remarkable achievement by an agency whose capacity has been severely strained by Brexit.

UK universities and NHS Trusts have made strong but uneven progress in trial reporting

Surge in trial reporting. Non-commercial trial sponsors across the UK have already uploaded more than twice as many clinical trial results onto the European trial registry in 2019 than during the preceding four years combined – even though posting results there has been mandatory since 2014. Nonetheless, 487 due trials run by UK universities and NHS Trusts are still missing results, and some institutions have made little or no progress.

Progress by universities. In recent months, UK universities have uploaded 293 trial results, compared to just 173 results uploaded during 2014-2018. Five universities have already attained a 100% reporting rate: East Anglia, Hertfordshire, Keele, Queen Mary, and Surrey. Overall, 72% of university-sponsored trials now have results on the European registry. A total of 180 university results are still missing.

Progress by NHS Trusts. NHS Trusts, which are public bodies within the UK’s National Health System, have uploaded 303 trial results over the past few months, compared to just 93 results posted over the preceding four years. Most NHS Trusts with sizeable trial portfolios have by now put over half of their trial results online. Among the larger sponsors, Guy’s and St Thomas’ stands out with 93% of its trials reported. University Hospitals Birmingham (only 6% reported) and University Hospital Southampton (13%) are negative outliers. Overall, 56% of NHS Trust trials have posted results. A total of 307 NHS Trust results are still missing.

Most clinical trials of medical devices remain unreported

Hidden medical device trials. While public and political attention has focused on the European registry, trials listed elsewhere have equal – and in some cases, greater – scientific and medical importance. For example, clinical trials of medical devices such as pacemakers, vaginal mesh implants, and artificial hips are listed exclusively on and ISRCTN.

The results of many of those trials will be lost forever unless their results are made public soon. For this reason, the World Health Organisation, Cochrane, Transparency International, TranspariMED and the AllTrials campaign have consistently demanded that the results of all clinical trials be made public

Medical device trials fly beneath the public radar. The European trial registry only captures certain types of drug trials. All other clinical trials run by UK institutions are listed on different registries. The world’s largest trial registry,, alone contains six times as many trials sponsored by UK universities than the European trial registry does. (Consolidated reporting data for the third trial registry commonly used in the UK, ISRCTN, is not available.) Sadly, the data set discussed above does not take these trials into account.

Mixed progress on device trials. While many UK universities have used the current momentum to strengthen their management of all trial registries, or report plans to do so soon, some universities continue to neglect trials not listed on the European registry. In January 2019, a stunning 97% of UK university trials listed on, 1,575 clinical trials overall, were still missing tabular results.

Urgent action required. At a minimum, institutions should identify those completed trials that have never reported results anywhere, and post their results onto registries. Going forward, institutions should routinely and consistently post the results of each and every clinical trial onto all registries where it is listed within 12 months of trial completion, in line with World Health Organisation best practices. (Some UK universities are already doing this.)

Chair of Committee: "Two-thirds compliance is not enough"

Norman Lamb, Chair of the Science and Technology Committee, said:

“It is encouraging to see that in general both Universities and NHS Trusts have worked towards improving compliance with their obligation to publish the results of clinical trials.

“A number of organisations have taken the Committee’s recommendations seriously and have now reported all their due results. Those institutions should be commended for taking action following my Committee’s Report.

“However, two-thirds compliance is not enough. I am disappointed that after almost eight months, we have seen only a modest improvement, and some institutions continue to ignore the Committee’s recommendations and flout the rules.

“When public money is spent on research, organisations need to recognise that they must be accountable - and that means full compliance. But the most important point is that failure to publish fully results in distortion of overall research outcomes. This is totally unacceptable.”

Dr Karla Soares-Weiser, editor in chief at Cochrane, said:

“At Cochrane, we rely on the availability of clinical trial data to produce high-quality and relevant systematic reviews. We welcome this effort among UK-based non-commercial clinical trial sponsors to improve reporting rates – though there is still clearly much more to be done for all sponsors to meet their full ethical obligations and achieve 100% compliance.

“Given that this issue goes far beyond the UK, we think it’s time for similar coordinated action on clinical trial transparency in other countries. We encourage researchers, healthcare professionals, patients and members of the public to get involved and to hold clinical trial sponsors to account on their reporting rates.”

Till Bruckner, founder of TranspariMED, said:

“Many universities and NHS Trusts have put considerable effort into fixing this problem, and every week more clinical trial results are being made public. This is excellent news for patients and taxpayers. However, some institutions have yet to upload a single result, and others continue to ignore trials of medical devices. This is unacceptable. The Health Research Authority must finally impose sanctions to ensure that each and every clinical trial involving UK patients is registered and promptly reported.”

Note: The compliance data cited above was collated by the EBM Data Lab using its EU Trials Tracker. TranspariMED did not independently check the accuracy of this data. The EBM Data Lab’s data set is available online.

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