The updated regulatory framework will expedite trial approvals and promote trial design innovation without affecting patient safety. New laws will be introduced in Parliament to address the need for a more effective, streamlined, and flexible clinical trial regulatory framework in the research industry. It will make the UK a more attractive place for innovators to conduct important research and will help to get potentially life-changing new treatments to patients and the NHS as quickly as possible. This marks an important milestone in the Medicines and Healthcare products Regulatory Agency’s biggest overhaul of the clinical trial regulations in 20 years, and will support taking trials to the patient.
The new legislation, which once made into law will come into force following a 12-month implementation period to ensure readiness, aims to reduce unnecessary administrative burdens on trial sponsors without compromising patient safety. It will see duplicative requirements removed and processes streamlined, with the introduction of the combined review and notification scheme for some clinical trial initial applications and amendments embedded into law. These changes are being introduced with support from health system partners including the Health Research Authority (HRA), academia and researchers.
The reforms were developed through a series of stakeholder workshops, seeking the views of a wide range of organisations and individuals from across the clinical research sector, including patient representatives. A public consultation took place in January to March 2022, to which over 2,000 responses were received, and the Government response was published in March 2023. Alongside the regulations, the MHRA and HRA are producing guidance to embed meaningful public involvement in clinical trials and increase the diversity of people taking part in research trials. This will ensure that research findings can improve everyone’s care, helping address health inequalities, because the UK is one of the best places in the world to do research that people can trust.
Modernizing the regulatory framework will strengthen the UK’s standing as a prime destination for conducting groundbreaking, safe clinical trials. This emphasized in Lord Darzi‘s Independent Investigation of the NHS in England, to make the UK more attractive for commercial clinical trials. To prepare the clinical trial community for the upcoming changes and facilitate a smooth transition to the new regulations, guidance will be developed through engagement with a wide range of stakeholders and will be published during the implementation period.
