UK Government Puts Its Foot Down on Clinical Trial Transparency
The UK’s Health Research Authority (HRA) as of Sept. 15 is requiring researchers to tell the agency at the end of their trials how they fulfilled their transparency requirements, including filing a lay summary of their trial findings that the authority will post on its public website.
Juliet Tizzard, director of policy and partnerships at the HRA, said that the authority has heard many accounts of participants never being informed of trial results, which has frustrated participants and made them hesitant to participate again.
“We will take a more proactive approach to prompting sponsors and researchers of clinical trials to keep their study information up to date in registries and all studies to submit a final report, through systems improvements and monitoring. We will publish the information we receive,” the HRA said.
The FDA has also been turning up the heat on sponsors and investigators who don’t submit trial results to ClinicalTrials.gov. It’s begun taking real action for the first time, issuing its first three noncompliance letters this year that carry the threat of monetary fines if the compliance problems went unfixed. The two sponsors and one principal investigator are now in compliance.