The HRA is committed to promoting research transparency and since October 2013 it has been a condition of the favourable ethical opinion for clinical trials to be registered on a publicly accessible register.
This must be no later than six weeks after recruitment of the first UK participant into the trial.
In support of this requirement, the HRA has completed a retrospective, two-staged review to identify the proportion of clinical trials that had been publicly registered following favourable opinion from a Research Ethics Committee (REC).
What we did:
We focused the review on studies listed as a clinical trial on the Integrated Research Approval System (IRAS) form.
This included Phase 1, medical device and ‘other’ clinical trials. Clinical Trials of Investigational Medicinal Products (CTIMPs) (Phases 2-4) were excluded on the basis that it is a legal requirement to register these on the EU clinical trials register via EudraCT.
In August 2015 we conducted the registration searches (Stage 1) of clinical trials registries (primarily the International Standard Randomised Controlled Trial Number (ISRCTN) and clinicaltrials.gov).
We searched using the full study title for studies that received a favourable opinion between 30 September 2013 to 30 June 2015 (Phase 1 trials) and 1 January 2015 to 30 June 2015 (medical devices and ‘other’ clinical trials).
Stage 2 was carried out in January 2016 and involved a follow up search of the registries to see whether the trial could be found. Where this was not the case, we contacted the Sponsor / Chief Investigator / Contract Research Organisation (CRO) to identify if the trial had been registered and if not, to enquire as to the reason for this.
The UK is leading the way in terms of the registration of Phase 1 studies. However, we do have a system in place for sponsors to request a deferral of publication where there may be issues of commercial confidentiality.
What we found:
In total 800 clinical trials receiving a favourable opinion were included in the review.
Figure 1 provides a breakdown of the study type and the numbers found on a publicly accessible registry over the monitoring periods.
Figure 2 highlights a positive change from baseline to follow up across all studies types.
Phase 1 studies had the largest proportion of trials registered with more than 60 per cent at baseline to just over 75 per cent at the end of the monitoring period.
Increased awareness by the HRA to highlight the requirement around trial registration may have acted as a catalyst for registration in many cases.
The HRA recognises that ethical and moral obligations of researchers and research sponsors set out a best practice standard for all health research to be registered.
Through our commitment to promote research transparency, the HRA will continue to routinely monitor compliance of clinical trial registration requirement.
Where it is still unclear whether or not a trial identified in this review has been registered on a publicly accessible registry, the HRA will follow up.
We do acknowledge valid reasons for trials not being registered, for example recruitment of the first UK participants not having commenced.