The UK’s Health Research Authority is currently mulling over whether to disclose which clinical trials conducted in the country breached its own rules and global ethical standards by failing to register.
Since 2013, trial registration has been a regulatory requirement in the UK. Researchers conducting a trial must commit to registering it in order to receive ethics approval.
However, a 2015 audit conducted by the HRA – which oversees Britain’s regional ethics committees – showed that many researchers subsequently failed to honour their commitments and did not register their trials.
During last year’s enquiry by the UK parliament’s Science and Technology Committee, it emerged that the HRA had provided an academic researcher with access to data on unregistered clinical trials only on condition that he did not reveal details on which trials had not been registered.
Hearing about the Health Research Authority's refusal to disclose data on unregistered trials, the Committee’s chairman, Norman Lamb MP, burst out with a single exclamation - “Unbelievable":
Dr Goldacre: Simon [Kolstoe] did a fantastic audit of all the trials approved by his ethics committee. It was published in a journal. He reported the percentage of trials that published their results, but not the individual trials that did and did not report their results. My understanding of that— correct me if I am wrong—is that the Health Research Authority would not permit him to share that information.
Dr Kolstoe: A confidentiality agreement was signed with the sponsors. The Health Research Authority was able to use that information for audit purposes, but we were not allowed to publish it.
Chair [Norman Lamb MP]: Unbelievable.
To test the Health Research Authority’s commitment to transparency, TranspariMED recently filed a Freedom of Information request for the data held by the HRA on these unregistered trials.
In response, the HRA provided details on the trials that had been registered – but withheld data on those that had failed to register as required by its own rules.
At the time, transparency campaigners strongly welcomed the Health Research Authority’s 2013 policy and 2015 audit as groundbreaking steps forward for trial transparency, both in the UK and internationally.
In December 2017, Transparency International, Cochrane and CRIT jointly with TranspariMED called on governments to ensure that all clinical trials are registered and reported, and to effectively enforce existing laws and regulations. Trial registration of clinical trials is a universal ethical obligation under the Declaration of Helsinki.
Previous investigations by STAT News and two trials trackers developed by the EBM Data Lab at Oxford University have demonstrated that greater visibility of trialists’ and institutions’ performance leads to significant improvements in their performance. Improving this performance is in the interests of patients, taxpayers, and public health agencies in the UK and beyond.
Considering the overwhelming public interest in curbing reporting bias and evidence distortion in medicine, we strongly hope that the Health Research Authority will take the logical next step towards improving transparency in the field, and decide to make its own audit findings transparent.
Note: Additional information on the research integrity enquiry and HRA trial audits can be found on the TranspariMED blog.