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UK MPs call for greater action on clinical transparency and trial reporting

Published on 30/10/18 at 11:29am

The UK’s House of Commons Science and Technology Committee has argued in a new report that the failure of clinical trial sponsors to adequately report their findings is leading to a waste of resources and could pose a threat to public health.

The report builds upon the findings from the University of Oxford’s EBM DataLab, whose recently-launched EUTrialsTracker revealed that only 51.4% of 7,784 trials required to report their findings on the European Union clinical trials register (EUCTR) had done so. As a result, clinical decisions are made without consulting all of the necessary data.

The committee cited the case of lorcainide, a heart drug which was found to pose a mortality risk to those taking it, but this risk was not made public until the results were published in 1993, when it had already been available to US patients for some time.

The argument was also put forward that the UK government was misled into wasting £424 million in response to the H1N1 swine flu epidemic in 2009 as a result of “publication bias”.

“Eight out of the 10 trials that were used by the company to show the drug was useful in preventing complications such as pneumonia had never actually been peer-reviewed or published,” Dr Simon Kolstoe, a University of Portsmouth researcher, told the committee, leading the government to rely on “a marketing spiel claiming successful trials of this drug, rather than being able to consider the actual evidence of the drug efficacy for themselves.”  

The group said that more needs to be done to push sponsors to report the entirety of their study findings, putting pressure on the NHS Health Research Authority (HRA), which has held responsibility for ensuring transparency of research since 2014, to develop a strategy to rectify the problem. The body has said it is currently working with the industry to push forward on this.

Matt Fellows

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