Our EU TrialsTracker has now been live for four months. As of 10 January 2019, we have identified 8,062 trials registered in Europe that are unambiguously due to report results under EU guidelines; a total of 4,323 (53.6%) trials have reported results to the registry. We have also seen some institutions – for example Kings College London – improve their trial reporting performance dramatically and rapidly.
Our BMJ paper showed that non-commercial sponsors (mostly universities) were substantially worse at reporting results to the registry, when compared with drug companies. The House of Commons Science and Technology emphasised this worrying finding in their October 2018 report on clinical trials transparency:
Compliance with transparency rules varies by sponsor: while pharmaceutical companies have good rates of reporting within a reasonable timeframe, the picture is much more mixed for universities.
The Committee recommended that “every university should aim for 100% compliance.” We agree! So we decided to check the data, four months after launch of our tracker. How are UK Universities performing today?
The EU TrialsTracker allows you the check the reporting statistics for each individual trial sponsor that appears on the EU register (EUCTR). For instance here are the performance statistics for the University of Oxford. Each UK university can be individually searched by name and the status of each individual trial checked.
We’ve checked and summarized the current reporting statistics for every UK University in a single spreadsheet here (or see sheet embedded below). Of 148 private and public universities (including all the constituent schools of the University of London), 41 are listed as a sponsor for at least one trial on the EUCTR. 28 of those have at least one trial currently due to report results. 59.7% of all trials currently identified as due to report to the EUCTR have no results. In addition, some universities also have data issues, either caused by incorrect or inconsistent data from the sponsor or limitations of the EUCTR, that make certain trials impossible to assess. We supplement our EUCTR reporting statistics with data from our FDAAA Tracker, which allows sponsors to see when trials are required to report results to ClinicalTrials.gov under US law.
We shared our data to help sponsors comply. Regular readers will know that we’ve previously published feedback from trialists and university compliance staff saying both the EU and FDAAA trackers are providing valuable information to help them get all trials reported, compliant with the rules. To this end, we’ve included links to the relevant sponsor pages for each university 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.
If you find this data table of UK universities helpful, we could roll out “country dashboards” as a feature, depending on resources, so let us know. 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 would like help doing this, please get in touch: firstname.lastname@example.org.
Lastly, our work monitoring trial reporting is, sadly, hard to fund. That’s a specific and concerning issue: despite extensive discussion among policymakers and university leaders, sadly, no major UK funders offer a funding stream for research integrity work. We think this explains why progress has been slow on problems like trial reporting. So if you have any leads on how to keep building our high impact audit tools, do please let us know: email@example.com.
-Ben Goldacre and Nick DeVito