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Europe: Combined review to facilitate speedier set up for clinical research trials in the UK

2021/07/20  GOV.UK

The Medicines and Healthcare products Regulatory Agency is playing a pivotal role helping to ensure that the UK remains one of the best places in the world to deliver safe, cutting-edge research.

The unprecedented challenges of the last 18 months have shone a spotlight on UK clinical research. Through a heightened spirit of collaboration and innovation, the healthcare professionals, researchers, participants, regulators, medical charities and industry who make up our research ecosystem have made a huge contribution to the global effort on therapeutics and vaccines.

As we look forward, there is an opportunity to build on what we have learned and achieved and realise a bold and ambitious vision of clinical research delivery. The recently launched implementation plan for the government’s Recovery, Resilience and Growth (RRG) programme for UK clinical research, sets out the steps being taken over the next year, backed by over £64 million of government funding, to begin to turn the UK vision for clinical research delivery into a reality.

The Medicines and Healthcare products Regulatory Agency (MHRA) is playing a pivotal role helping to ensure that the UK remains one of the best places in the world to deliver safe, cutting-edge research. Part of this work is the combined review, which will provide a more streamlined and efficient service for research applicants. From January 2022, all new Clinical Trials of Investigational Medicinal Products (CTIMPs) in the UK will be subject to a combined review from the MHRA and the UK Research Ethics Services, in collaboration with the Health Research Authority (HRA), facilitating rapid start up and benefitting patients sooner.

Applicants need only make a single application for both Clinical Trial Authorisation and Research Ethics Committee (REC) opinion and approval is delivered together. A number of sponsors have already used this new process with some reporting a 30 per cent improvement in overall trial set up times.

This work is part of the transformation of the Integrated Research Application System (IRAS). We are collaborating with the HRA, the devolved administrations, the National Institute for Health Research (NIHR) and other research partners to create a world-class hub for health and social care research in the UK, with smooth and intuitive access to research approval, study management, best practice guidance and lay-friendly information about the results of research.

We’ll provide further information on any changes researchers and/or sponsors need to make in good time, including how applicants can access support with the new system.

However, applicants are encouraged to start using the service now so they can ensure their internal processes and systems are aligned for January 2022, when all approvals for CTIMPs will be processed via the combined review. Get started now by visiting https://www.hra.nhs.uk/combined-review.

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