MPs have issued a strong call for the government to take responsibility for getting missing clinical
trial results reported today. The House of Commons Science and Technology Select Committee
report on Research integrity: clinical trials transparency makes a series of recommendations to
Government including high level political leadership on transparency to setting up a detailed audit of
reporting rates of all UK trials. The committee urges the Health Research Authority (HRA) to run that audit and to start to sanction researchers who aren’t reporting results.
The MP’s report is an excellent summary of the state of clinical trials transparency in the UK and we recommend reading it. It highlights the work AllTrials and the DataLab at the University of Oxford have already done to uncover information about unreported trials and includes information from EU TrialsTracker, our new website which displays the clinical trials carried out in the EU which have broken EU rules on reporting results. The tracker currently shows that only 51% of clinical trials on the EU register have followed the rules and reported results there.
Rt Hon Norman Lamb MP, Chair of the Science and Technology Committee, 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 tax payer has a
right to expect those who benefit from public funding to follow the rules and publish in full.”
“People take part in these trials in good faith, hoping to help inform doctors and decision makers on
vital issues affecting many of us every day. Their efforts are betrayed if the results are not made
available at the end.”
The Health Research Authority responded that “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.”
Dr Ben Goldacre of the DataLab in University of Oxford and co-founder of AllTrials said that the
HRA’s response is admirable. “They have reflected, they recognise there is a problem, they are
taking action. They are looking at the practicalities of fixing the problem. This is great stuff, but it’s
also great leadership, and what a public body should do, when presented with ethical breaches.”
Síle Lane, Sense abut Science one of the co-founders of AllTrials said, “There is no excuse for failing to report clinical trial results. So, why should Imperial College London be allowed to run one more trial, while they have not posted results for three quarters of their currently overdue trials? Or the University of Nottingham, which has reported results for just 1 out of their 17 overdue trials on the register? Why should these institutions be allowed run any more trials on patients? Why are ethics committees giving them permission to run more trials? Why are funders paying for them? Before we pay for new clinical trials, let’s make sure we get value from the trials we’ve paid for already.”