Trial Reporting at NHS Trusts in England

Nearly all trials of medicinal products conducted in Europe since 2004 are required to post their results directly onto the EU trials register within one year of completion. Since September, our EU TrialsTracker has monitored all clinical trials in the EU to check whether they are compliant. Recently we produced a specific report on data on trial reporting at UK Universities: the House of Commons Science and Technology Committee is currently using this data to alert Universities and monitor their current reporting performance.

Today we’re sharing another cut of data relevant to the UK: trial reporting at NHS Trusts in England. For those of you not familiar with the UK system, most larger public healthcare institutions outside of primary care are organised into “Trusts”. This can include hospitals, mental health services, and ambulatory services. A large amount of healthcare research in the UK is sponsored by, and conducted within, these Trusts.

A report from the House of Commons SciTech Committee highlighted that many of these Trusts are failing to comply with EU rules on clinical trial reporting:

Meanwhile, many NHS Trusts have high numbers of unreported clinical trials according to the site: the Manchester University NHS Foundation Trust has 13 overdue trials, NHS Greater Glasgow and Clyde has 12 that are due to have reported, and both Newcastle upon Tyne Hospitals NHS Foundation Trust and Hull and East Yorkshire Hospitals NHS Trust have 11 outstanding trials.

Below we provide a full list of all research sponsored by NHS Trusts from the EU register. As with any sponsor, you can also check the individual sponsor page for each NHS Trust on our EU TrialsTracker for live updating data. The NHS lists 234 active Trusts in England as of November 2018. 107 (45.7%) sponsor at least one trial on the EU register. NHS Trusts sponsor 1,209 trials in total on the EUCTR. 62 Trusts have at least one trial due to report results. Out of 263 due trials, just 93 (35.4%) have submitted results to the EU register (as required by EU guidelines): this is much worse than the compliance rate elsewhere (59.7% compliance for UK Universities, and 54.1% for the EU register overall). In addition, some Trusts also have trials whose compliance cannot be assessed, usually due to incorrect data provided by the Trust itself.

As with our University data, we also present compliance with reporting requirements on the US registry, ClinicalTrials.gov. Our FDAAA TrialsTracker shows compliance with US law (the FDA Amendments Act 2007) for all sponsors. As you would expect, the numbers are smaller: as of February 2019, there are only 13 trials sponsored by NHS Trusts covered under US reporting rules, of which only one is due to report results, but that trial is currently unreported on the register and therefore in breach of US law. You can see the data here, or take a look at the google sheet embedded at the bottom of this post.

As always, we share this data to help sponsors meet their ethical and legal trial reporting obligations. There are links to all the relevant sponsor pages from our EU Trialstracker for each Trust in the spreadsheet. We hope that sponsors will use this data to assess and improve their current reporting performance, and ensure their registry data is all current and correct.

Please let us know if you find this useful. We’re currently looking for resource to roll out specific dashboards based on out TrialsTrackers. Highlighting compliance at NHS Trusts is one example of a new feature we could implement with additional funding. We’re also always happy to help any interested parties get the information they need to ensure all trials are fully reported in accordance with their ethical and legal responsibilities. If you have any questions, or have any leads on funding for this type of work, please do get in touch: bennett@phc.ox.ac.uk.