Following a Freedom of Information request by TranspariMED, the UK’s Health Research Authority has released a data set of clinical trials that may have remained unregistered.
Trial registration is a universal ethical obligation under the Declaration of Helsinki and has been a UK regulatory requirement since September 2013.
Determining actual trial registration rates is notoriously difficult, as unregistered clinical trials remain invisible unless and until their outcomes are made public – which in many cases never happens. As a result, the evidence base on drugs, medical devices and treatments is riddled with gaps and biases, with negative consequences for patient safety, public health, and medical progress.
The data now released by the HRA provides a unique opportunity to determine exactly how many clinical trials in one country have remained unregistered.
The HRA compiled its database by compiling and reviewing the (mandatory) formal ethics approvals issued for all clinical trials conducted within the UK during a 21 month time period, and was thus able to capture every single trial.
At the time, the HRA audited its own data and found that it was unable to locate registration data for 101 trials, including 23% of Phase I trials, 40% of medical device trials, and 40% of other trials.
However, the HRA has cautioned that the true proportion of unregistered trials is likely to be somewhat lower:
“Where trials could not be located on a publicly accessible database, this does not necessarily mean that they have not been registered.
The requirement to register is no later than 6 weeks after recruitment of the first participant and this time point may not have been reached at the time of searching.
It is unlikely that studies will have commenced immediately after the favourable opinion has been issued; in which case there would be no expectation that these studies are registered at the point of audit
Not finding the trial may have been due to the search method rather than the trial not having been registered”
The data set will enable independent researchers to revisit all these trials and determine which of those still remain unregistered.
Till Bruckner, founder of TranspariMED, said:
“The Health Research Authority’s move is a welcome further step towards greater clinical trial transparency. As a result, we will not only be able to determine exactly how many trials failed to register, but also to identify the institutions that conducted these trials, and alert them to the fact that their policies and safeguards may need strengthening.”
The HRA’s data set covers most clinical trials that received ethics approval in the UK over the 21 month time period between 30 September 2013, when trial registration became compulsory, and 30 June 2015. It identifies 101 trials for which no registration record could be found.
TranspariMED has already contacted several academics asking them whether they might be interested in digging into it. If you are interested in working with this data set, please get in touch with TranspariMED first to avoid possible duplication of efforts.
Note: Additional information on HRA clinical trial audits can be found on the TranspariMED blog.