UK To Up Transparency By ‘Auto Registering’ Trials
Latest HRA Audit Shows Over 10% Trials Failed To Comply With Mandatory Trial Registration
The UK says its initiative to unilaterally register clinical trials when they are given a research ethics committee approval will make it easier for trial sponsors to comply with their transparency requirements.
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The UK regulatory agency, the MHRA, is planning to establish a “world-class sovereign regulatory environment” for clinical trials to support the development of new innovative medicines. In the first of two articles, we look at the MHRA’s proposals to slim down trial approval processes, lighten the safety reporting burden, and introduce greater transparency of trial registration and results.
The UK has started monitoring whether clinical trial sponsors are fulfilling responsibilities to make their research open and transparent.
Ongoing efforts by the UK to deliver a single decision on the ethical and regulatory approval of new clinical trial applications have reached a major milestone ahead of the 2022 mandatory deadline.