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170 clinical trials run by NHS Trusts violate disclosure rules

Two thirds of clinical trials run by NHS Trusts have not posted their results, a new analysis shows. Out of 263 clinical trials completed more than a year ago, only 93 have results on the European registry. NHS Trusts have failed to post results for the remaining 170 trials, in violation of EU guidelines.

There are huge variations in the trial reporting performance of individual NHS Trusts. Seven trusts have posted the results of every single due trial, but dozens of trusts have posted not a single trial result.

The trial reporting performance of the ten NHS Trusts with the largest number of due trials is shown below.

The results of many clinical trials funded by public money and involving NHS patient volunteers may be lost forever unless these trusts take actions soon.

Debra Winberg, a postgraduate researcher at the London School of Economics, has already identified several trials that were completed by NHS Trusts many years ago but have never published their results anywhere, as part of an ongoing research project conducted in collaboration with TranspariMED.

According to EU guidelines, each and every clinical trial listed on the EU registry must post its summary results there within 12 months of trial completion.

Posting all clinical trial results onto registries is important regardless of publication in academic journals, for several reasons:

  • Posting results onto registries accelerates medical progress because the 12-month timeline permits far more rapid results sharing than the slow academic publication process allows.

  • Posting results onto registries minimises the risk of a trial never reporting its results and becoming research waste, which can happen when a principal investigator dies or leaves their post during the prolonged process of submitting an academic paper to a succession of medical journals.

  • Research shows that trial results posted on registries typically give a more comprehensive and accurate picture of patient-relevant trial outcomes than corresponding journal articles do.

  • Results posted on registries are easier to locate and are open access.

  • Registry reporting facilitates comparison of trial outcomes with a trial’s originally stated aims, and thus discourages harmful research malpractices such as the ‘silent’ suppression, addition, or switching of selected outcomes, HARKing, and p-hacking.

Overall, the reporting performance of NHS Trusts (35% average) is even weaker than that of UK universities (60%).

Following pressure from transparency advocates and parliament, many UK universities and NHS Trusts are now working hard to upload missing clinical trial results, so these numbers are likely to substantially improve over the coming months.

While some institutions on the continent are also starting to tackle the problem, taken as a whole, non-commercial trial sponsors in the rest of Europe tend to perform significantly worse than their UK peers, and are lagging behind in addressing the issue.

Nearly half of Britain’s 234 NHS Trusts have sponsored at least one trial listed on the European registry. In total, the registry lists 1,209 trials sponsored by trusts, but most of these are not yet due to post results. The full data set covering all NHS Trusts was compiled by the EBM Data Lab at Oxford University, and can be found here.

For comparison, this recent report by TranspariMED and UAEM contains performance data for UK universities.

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