The Medicines and Healthcare products Regulatory Agency announced funding this week to support three projects aimed at driving regulatory innovation in the Healthcare and Life Sciences sector. 

The MHRA will receive nearly £1million from BEIS' Regulators' Pioneer Fund which will enable research in three areas:

  • Using synthetic data to create artificial control groups for clinical trials
  • Using AI products in clinical settings
  • Regulating microbiome therapeutics and diagnostics

All three give insights into emerging uses of technology which the Government believes may become an everyday feature of the UK's healthcare system in future. They also provide an indication of the MHRA's desire to make the UK a desirable destination for companies looking to bring innovative Health Tech products to market.  

Artificial patient data in clinical trials

The majority of the £970,688 BEIS funding will go towards a project aiming to create data sets of artificial patients which can be used to create control groups for clinical trials. If successful, these synthetic data sets could help to increase patient numbers and better reflect groups which are traditionally less well represented in clinical trials. Artificial patient data could also remove the need to protect patient privacy when collecting data, reducing the time and cost of conducting clinical trials.

Dr Puja Myles, Director of the Clinical Practice Research Datalink at the MHRA, said: "This funding could revolutionise how clinical trials are conducted, giving patients access to potentially life-changing treatments, saving money that could be better spent on more advanced research while providing highly reliable results for the clinical researchers."

Using AI as medical device

The second project will explore how to explain to clinicians the process by which AI products make decisions in clinical settings. The aim is that by helping clinicians to understand the basis of the AI decision, they will then be able to assess what weight to give those decisions when determining diagnosis and treatment, helping to introduce complex "black box" AI products into clinical practice. 

The MHRA hopes this project will help to speed up some of the regulatory reform of AI as medical device which we posted about recently MHRA reveals roadmap for regulatory reform of Software and AI as a medical device. 

Guidelines for regulating microbiomes

The final project is aimed at helping regulators develop guidelines for the use of microbiome-based diagnostics and therapeutics. Use of microbiomes as a healthcare product is a new and complex field, where rapid advancements are being made. As with any emerging field, this brings huge challenges for regulators trying to understand and keep pace with developments so that society can benefit from new technologies while ensuring patient safety.

A microbiome is the community of microorganisms (bacteria, viruses and fungi) living together in a body. New technologies are now allowing researchers to understand better the interconnected and hugely complex nature of the human microbiome in order to harness its potential for diagnosis and treatment.

If you would like to discuss how the current regulatory regime or future changes might impact you or your products, please contact our Health Tech team.