MHRA says AI can accelerate trials and speed recruitment

AI could accelerate drug development by helping preclinical candidates move into human trials faster, according to the UK Medicines and Healthcare products Regulatory Agency (MHRA).

The regulator spoke about the potential benefits of AI this week, citing its efforts to develop predictive computer models of drug studies as an example.

A spokesperson told Clinical Insider, “The MHRA has numerous AI projects underway, including our involvement in the creation of Centres of Excellence for Regulatory Science Innovation (CERSIs).

“Within this, a team within the MHRA is supporting the CERSI on in-silico trials — virtual simulations of how medical products might behave. These trials could help us move faster from preclinical to clinical testing, and address issues like recruitment delays.”

Synthetic data

Last week, the government’s Department of Science Innovation and Technology (DSIT) spoke about the potential role AI has in making the UK a more attractive location to trial candidate medicines, citing a recent MHRA project as an example.

The 18-month project — which was carried out in partnership with researchers at Brunel University and Birmingham University — looked at the potential use of high-fidelity synthetic data to boost sample sizes in clinical trials.

The aim of MHRA’s AI project is to use the technology to augment — rather than replace — the work of regulators, according to the MHRA spokesperson.

“AI-facilitated advances have the potential to enhance our activities, delivering safer, faster, and more consistent regulation to benefit both patients and innovators.

“It’s important to note that the adoption of this technology is not intended to replace the expertise of our experienced and knowledgeable scientific assessors but rather give them more time to focus on higher risk analyses and more finely balanced judgements,” the spokesperson said.

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