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Regulatory Focus™ > News Articles > 2019 > 8 > UK Committee Insists on Sanctions for Trial Reporting Failures

UK Committee Insists on Sanctions for Trial Reporting Failures

Posted 23 August 2019 | By Ana Mulero 

UK Committee Insists on Sanctions for Trial Reporting Failures

The UK House of Commons Science and Technology Committee echoed on Friday the call from 12 patient groups to impose a system of sanctions for failing to report results of clinical trials.
“The Health Research Authority (HRA) must follow my Committee’s recommendation from last Autumn to introduce a system of sanctions for those who do not comply with reporting results requirements for clinical trials,” Commons Science and Technology Committee Chair Norman Lamb said in response to an open letter from 12 patient groups. “For too long there has been little consequence to non-compliance with current requirements and it’s time action was taken.”
The coalition called on Lamb in the 20 August open letter to put pressure on HRA to follow the committee’s recommendation—initially set forth in 2013 and restated in an October 2018 report and subsequently support in a February request from the UK government—on introducing penalties on sponsors or investigators for failing to comply with rules on reporting trial results.
The UK government and HRA were already in discussions to put in place a system for imposing sanctions as of February but a May letter from HRA and a recent meeting of an HRA transparency group revealed pushback.
The HRA “group agreed that we need to tighten up the requirement here as it is crucial that registered studies report their results” but “felt that discussing firmer sanctions was premature and that before that it explored we should do much more to facilitate compliance through better systems, collaboration with funders, data sharing and making information public,” HRA said


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