Measures include a requirement to publicly register studies and share results among research participants
The Medicines and Healthcare products Regulatory Agency (MHRA) – in collaboration with the Health Research Authority (HRA) – has announced a rebooted regulatory framework for clinical trials across the UK.
Updated measures include a legislative requirement to publicly register studies and disseminate results among research participants. This also includes providing guidance which will help researchers involve people with lived experience in clinical trials, while recruiting more diverse cohorts of participants.
Richard Torbett, ABPI chief executive, was positive about the changes: “It’s great to see the MHRA taking forward these important changes to UK clinical trials regulation centred on patient safety and the benefits of participating in research. The reforms are a significant step forward for UK clinical trials and come at a crucial time for industry clinical research in the UK.
He added: “We welcome the MHRA and HRA’s commitment to work with our industry to co-develop new regulatory guidance and their pragmatic approach to patient and public involvement and trial diversity. We look forward to working with them to make the UK an attractive destination for clinical trials.”.
Meanwhile, under the framework, clinical trials application processes in UK will be more flexible proportionate and streamlined without compromising safety. It is hoped this will assist in cementing the UK as an appealing destination for trials, including global multi-site studies.
The MHRA will also incorporate a timeline for completing an application review within a maximum 30 days in general – with a maximum ten days for a decision to be granted once the regulator has received final details.
It is believed that the legislative alterations will result in a regulatory framework that is as future-proof as possible.
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