UK backs AI-generated placebo groups to speed drug trials

AI-generated, synthetic clinical trial data has the potential to speed up drug research, according to the UK government.

The UK Department for Science, Innovation and Technology (DSIT) made the comments last week, citing a recently completed Medicines and Healthcare products Regulatory Agency (MHRA) project that saw researchers use AI-data in place of a placebo control group as the basis for the idea.

“This approach can make trials quicker, cheaper, and more inclusive, while still ensuring safety and effectiveness. Patients could benefit from faster access to new treatments, supporting efforts to improve health outcomes and reduce pressure on our NHS,” the DSIT wrote in a press statement.

This was echoed by Puja Myles, director of the clinical practice research datalink at the MHRA, who said the project “has given us a better understanding of the scenarios when synthetic data could be used to boost sample sizes of clinical trials.”

Innovation

Support for the MHRA project was provided through the third round of the Regulators’ Pioneer Fund (RPF), which provides grants to government agencies to encourage the elimination of rules that hinder innovation.

A DSIT spokesperson told Clinical Insider, “The Regulators’ Pioneer Fund, which is part of the Regulatory Innovation Office, supports UK regulators and local authorities to adopt new and experimental regulatory approaches that seek to remove barriers to innovation and help businesses get their innovative products and services to market faster.

“It enables regulators and local authorities to act with impact to respond to innovation and grasp emerging opportunities, thus supporting the growth and productivity of the UK economy.”

AI key to UK trial regs overhaul

DSIT’s comments fit with other instances of government support for AI in trials. For example, in April, UK R&D agency ARIA awarded contractor Lindus Health funding to develop an AI system for study design optimization.

The comments are also in keeping with the regulatory shake up the UK government announced last month, which aims to provide a regulatory “framework that is streamlined, agile, and responsive to innovation.”

In a recent post about the planned changes, MHRA chief executive Lawrence Tallon said AI “could speed up vital parts of our clinical trial application review from three hours to just 35 seconds.

“The time this saves allows our clinical trials team to support new initiatives, such as life sciences innovation and upstream advice,” he added.

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