MHRA will receive the near £1 million support to fund three projects that aim to improve how patients can access life-changing treatments in clinical trials, find a way to introduce complex AI safely into front line clinical settings and make the UK the place to launch advanced microbiome products that can support the development of personalised medicine.
The first project has been awarded £750,387 to tackle the challenges of finding control groups for clinical trials, through the development of alternative synthetic datasets.
Currently, patients run the risk of being randomly assigned to control groups and therefore are denied access to treatments that could improve their symptoms or extend their life, and clinical trials for rare diseases can often find it difficult to recruit enough patients for their trials altogether.
The second project aims to address the issue of how to safely introduce complex ‘black-box’ AI products into clinical settings, so that clinicians can be confident that the decision from the AI device is appropriate and suitable in that specific context.
This project will accelerate key parts of the recently published roadmap for the Software and AI as a Medical Device change programme, the MHRA’s ambitious programme of reform to ensure that medical device regulation is fit for purpose for software, including AI.
The third project has been awarded £52,438 to explore the development of guidelines around regulating microbiome therapeutics and diagnostics, a rapidly emerging field that poses a challenge for regulators and companies due to its novel and complex nature.
Therefore, appropriate internal and external guidance based on expert scientific knowledge are needed to facilitate the regulatory process, bring confidence to the microbiome field and ensure the safety of patients.