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Piloting progress: The new HRA fast-track ethics review - a blog by Dr Nicole Mather, HRA non-executive director

Last updated on 25 Feb 2021

Accelerating research to enable benefits for citizens is front page news more than ever before. At the Health Research Authority, during the pandemic we have made some high-impact service improvements. This includes the 24 hour fast-track service for urgent COVID-19 public health research and a COVID-19 patient-matching service, increasing patient involvement in study design to higher levels than before the pandemic.

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The HRA has also developed a new fast-track pilot for ethics review for non-COVID-19 global trials and first-in-human studies. This aligns with work by system partners such as MHRA and NIHR to shape the future: across the UK health research ecosystem, we recognise the opportunity and importance of embedding the learnings from the pandemic to build back better than before.

There have been high levels of interest in our new pilot fast-track system, significantly accelerating the ethics review process, while maintaining the quality and openness of the approach. This pilot allows us to collect feedback from applicants, our HRA teams and REC members as users of the service, as well as testing some operational changes and evaluating their impact. We will use this information to inform our future design decisions and ensure good value for money in our new approach.

The response to date has been very encouraging with 80 expressions of interest from across industry and non-commercial sponsors. We have had 28 studies reviewed through this new pathway in just six weeks with a review period of just 14-16 days. This means that study sponsors can quickly begin to focus on site set up and patient recruitment.

At the HRA, we are determined to play our part in shaping the future of research. For example, PRINCIPLE is a UK national platform trial investigating COVID-19 treatment of older people in the community at high risk of complications. This approach has been supported by a multi-disciplinary team including the NIHR and HDR-UK. HRA reviewed PRINCIPLE through our 24h process enabling 4,296 patients to participate. This trial focuses on repurposed therapies and has to date demonstrated that azithromycin and doxycycline are not effective, and is currently focusing on budesonide.

The UK research ecosystem is redesigning itself to accelerate the research of the future, seizing the opportunity to build back better, transforming the experience of researchers and cementing the role of the UK as a leading global hub for life sciences. Combined with ongoing investments in UK research and health data infrastructure, our work at the HRA will form part of a future environment to attract more research into the UK and help patients from across all corners of the UK to benefit from cutting edge research.

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