The Health Research Authority’s new service offering a 50% faster research ethics committee review for non-COVID clinical trials in the UK is set to continue.
The decision to offer to fast-track ethics review follows positive feedback from pharmaceutical companies and contract research organisations who have taken part in a three-month pilot of the accelerated service.
Available for global trials and first-in-human studies, developing medicines in key areas of patient need such as heart disease and diabetes, the service uses an expert fast-track committee to provide a consistent and efficient approval process.
The extension of the service provides an opportunity to fully evaluate the pilot and explore how a fast-track ethics review can be incorporated into wider rapid approval and study set-up processes. This includes integration into the combined review with the Medicines and Healthcare products Regulatory Agency, which offers a single application, combined review and decision for a clinical trial.
Dr Matt Westmore, Chief Executive of the Health Research Authority‘This is an exciting step forward following great demand for our fast-track ethics review service for non-COVID-19 studies.
‘The fast-track service is one way we are using our experience of approving urgent COVID-19 research to help rebuild a strong research environment for all types of research, and to ensure that the UK maintains its world-leading reputation for health and social care research.
'We are playing our part to help new high-quality research studies get set up in the NHS and beyond – operating at pace but without lessening the important protection ethics review provides for patients and health volunteers taking part in research.’
Fast-track ethics review applicant'The process of submitting through the pilot was straightforward and responses to any operational questions were answered swiftly, which really helped in the use of a new process.
'Having study documents reviewed within days of submitting really saved valuable time for Phase 1 studies. I thought using the pilot was great and I hope this continues as it will have a great impact on our projects.'
Nicola Adey, Head of Regulatory Affairs, UK and Ireland PSI CRO UK Ltd'We found the fast-track review service to be extremely fast and efficient and wouldn’t hesitate to use the service again.’
Ethics review makes sure that patients and healthy volunteers taking part in clinical trials and other research are protected. Expert committees look at how participants are recruited, what information they receive and how they can join or withdraw from the trial.
The fast-track ethics review service uses a dedicated ethics committee with expert staff, working virtually to shortened timelines. It builds on the Health Research Authority’s COVID-19 approval service, which has offered fast-track reviews for around 800 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 new fast-track research ethics review service is building on.
For further information about the new fast-track research ethics review and the entry requirements, please visit www.hra.nhs.uk/fast-track-ethics-review.