UK: UK seeks to increase clinical trials transparency

26-02-2019

UK: UK seeks to increase clinical trials transparency

(Source: RAPS 2019-02-25)

The UK government issued a policy paper to improve clinical trials transparency in response to 10 recommendations a House of Commons Science and Technology committee report offered in 2018.

“Research findings must be communicated in ways that are timely, meaningful and relevant to evidence users,” Parliamentary Under-Secretary of State for Health Baroness Blackwood said, welcoming the chance to address the October 2018 report. “Only with a system which values transparency can we hope to improve patient care and support the sustainability of the health and care system through research.”

The first recommendation called for an explicit commitment on introducing requirements to support clinical trials transparency under the EU’s new Clinical Trials Regulation (CTR), which is set for implementation in 2020. In response, the new policy paper pointed to an April 2018 reaffirmed commitment of the UK government to “implementing all of the requirements” of the CTR “that are within its control.”

Responses to recommendations two through five make note of an upcoming requirement on data submissions to better monitor commitments of the university sector, plans to call on units within the National Health Service in England in helping to ensure publication of clinical trial results identified by the report, the development of “model clinical trial agreements” for pharmaceutical research, as well as considerations already underway at the Health Research Authority (HRA) around gathering definitive clinical trial registration information. The response to recommendation six is a slightly more detailed version of the response to the fifth, adding HRA plans to publish an outline of its new strategy in 2019.

Responses to recommendations seven through nine describe how the government committed to identifying how best to direct HRA to publish information on unregistered clinical trials and asking HRA to publish its new transparency strategy by year’s end, as well as working with HRA to strike the right balance in new measures to improve transparency. The UK government is “consulting further with HRA and other stakeholders on how best to drive improvements in transparency and how this can be achieved in relation to the remit of the HRA,” the response to the tenth recommendation says.

The policy paper comes as a no-deal exit looks increasingly likely, with the 29 March deadline approaching. Guidance on no-deal Brexit preparations from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) includes guidance issued last October on the supply of investigational medicinal products for clinical trials and January guidance on arrangements to modify existing regulations on trials, pharmaceutical and medical devices. The UK government also published three pieces on draft legislation in January for the regulation of pharmaceuticals, devices and trials as part of contingency planning in the event of a no-deal Brexit.

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