UK Agency to Up the Ante on Trial Transparency
Clinical trials in the UK will have to pay more attention to data transparency under a new strategy being developed by the National Health Service’s Health Research Authority (HRA) that would offer sponsors and researchers both support and sanctions.
HRA says in a policy paper issued last week that it will develop a strategy to ensure all trials are registered, results are reported and information is shared with trial participants. Currently, HRA says, 30 percent of UK trials are not registered, 25 percent of trials do not report results and only 10 percent share findings with trial participants.
The agency’s plan, which it intends to carry out over the next two years, includes taking the registration responsibility out of sponsors’ hands and registering trials itself. Reporting rates will be enhanced by establishing a standard format for final trial reports and sending reporting reminders to sponsors and investigators. HRA will improve participant communication by requiring researchers and sponsors to submit a lay summary of trial results for publication on the agency’s website.
The strategy also has a performance review component that includes publishing information on individual trials’ transparency performance and making an assessment of a sponsor’s compliance part of the approval process for new studies. HRA also plans to establish sanctions for noncompliance, although its policy paper does not specify how they will be determined.
To read the HRA plan, click here: https://bit.ly/39HzDbw.