MPs call for more transparency around clinical trial results

Concerns over scientists who fail to divulge the results of their clinical trails have been raised in a new report.

The House of Commons Science and Technology Committee said that failure to publish data from such research holds a “risk to human health”.

The group of MPs called for increased transparency surrounding clinical trials.

It has previously been alleged that nearly half of clinical trials fail to publish their results.

This presents a risk to human health as well as increasing research “wastage”, the MPs said.

The committee’s latest report said that “selective non-publication of the results of research distorts the published evidence base and is a threat to research integrity”.

MPs heard that “publication bias” may have led to money being wasted from the public purse, for example when the Government decided to spend £424 million to stockpile Tamiflu in response to the H1N1 “Swine Flu” epidemic in 2009.

During hearings, MPs were told that: “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”, which meant that governments were “relying 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”.

Meanwhile, a trials tracker website claims that Public Health England has three overdue trials relating to meningitis vaccination and many NHS Trusts have high numbers of unreported clinical trials.

MPs said that the NHS Health Research Authority (HRA) has not done enough to improve reporting rates, even though it has been in charge of “promoting research transparency” since 2014.

They said that the HRA should be given the funding it needs to produce an official list of which trials have reported results and which ones have not.

The report adds that the HRA should introduce a system of sanctions to drive improvements in clinical trials transparency, such as withdrawing favourable ethical opinion or preventing further trials from taking place.

Commenting on the report, committee chairman Norman Lamb said: “An astounding amount of information from clinical trials is going unreported.

“The HRA must act now to ensure current regulations are enforced and impose tough sanctions on those who seem to think it is acceptable to disregard valuable research, threaten research integrity and, in some cases, endanger human life.

“Many of these trials are funded with public money and the taxpayer has a right to expect those who benefit from public funding to follow the rules and publish in full.

“It is particularly disappointing that trusted bodies such as Public Health England and a range of NHS Foundation Trusts are failing to report results from clinical trials. Public trust in medicine could easily be eroded by these failings from such important parts of the health system.”

Dr Mary Ramsay, head of immunisations at Public Health England, said: “We register all our trials on the EU Clinical Trials Register before they begin and are in the process of uploading our results data to it. We are committed to transparency and have already published this data publicly in academic journals and online at clinicaltrials.gov.”

Teresa Allen, chief executive of the HRA, added: “We are committed to do more to drive research transparency, which is both a good practice requirement and long-standing ethical principle.

“Transparency is essential so that participants are protected from unnecessary research and patients benefit from improved outcomes and care informed by high quality studies.

“We will act on the recommendations published by the select committee today, and report on our progress.”