The Health Research Authority has launched a new service for pharmaceutical companies and research organisations seeking to start clinical trials of medicines in the UK. It will offer swift review of global trials and first-in-human studies, developing medicines in key areas of patient need such as heart disease and diabetes.
The service, to fast-track the vital ethics review stage of clinical trials approval, will run in pilot form for the next three months. It will offer a 75% reduction on the statutory timeline for ethics review, contributing to quicker set up of new research studies in the NHS and beyond.
Ethics review checks that patients and healthy volunteers taking part in clinical trials and other research are protected. Expert committees look at participant-facing aspects of the trials such as how they are recruited, what information they receive and how they can join or withdraw from the trial.
The new service, offered as a pilot until March 2021, uses a dedicated ethics committee with expert staff, working virtually to shortened timelines. The pilot will test the demand, and the financial and practical feasibility of a fast-track ethics review service.
The fast-track research ethics review service builds on our COVID-19 approval service, which has offered fast-track reviews for almost 700 COVID-19 research studies in record timelines. This speed was made possible by unsustainable factors such as out of hours working and a reduction in non-COVID 19 research. However, the experience has opened-up new possibilities which the pilot service is building on.
Professor Sir Terence Stephenson, Chair of the Health Research Authority‘Ethics review provides important protection for patients and healthy volunteers taking part in research. During the pandemic, the HRA has offered swift ethics review of COVID-19 research whilst maintaining robust standards. We now want to use our experience of responding to COVID-19 research to help rebuild a strong research environment and ensure that the UK maintains its world-leading reputation for health and social care research.’
This pilot sits alongside the HRA’s separate pilot service with the Medicines and Healthcare products Regulatory Agency (MHRA) offering a single application, combined review and single decision for a clinical trial. If our fast-track ethics review pilot is successful, we will develop a fast-track combined review, enabling clinical trials to get from application to first recruit in record times whilst maintaining high standards of safe and ethical research.
Lord Bethell, Minister for Innovation‘This is an exciting step which demonstrates the UK’s continued innovation and further cements our position at the forefront of world-leading research.
The quality of our research into COVID-19 has proved vital across the world - from finding new treatments to bringing forward a vaccine – and the Covid-19 process has shown it’s possible to carry out a fast-track ethics review without lowering safety standards. Being able to apply this rapid innovation to research into other diseases will ultimately mean patients can safely access ground-breaking treatments more quickly.’
For further information about the new fast-track research ethics review pilot and the entry requirements, please visit www.hra.nhs.uk/fast-track-ethics-review-pilot.