MHRA reports high pharma investment in UK trials

Drug companies are continuing to invest in trials in the UK, according to new Medicines and Healthcare products Regulatory Agency (MHRA)-backed research.

The study looked at 4,616 clinical trial submissions received by the UK regulator between February 2019 and October 2023 and found that the majority came from for-profit drug developers.

“Our data analysis confirmed that 85% [of trial submissions] were from commercial sponsors, which shows that pharmaceutical and biotech companies invest heavily in clinical trials in the UK to develop new drugs and therapies,” the authors wrote.

Of the clinical trial submissions filed by commercial sponsors, 25% were for Phase I, 26% were for Phase II, and 33% were for Phase III. About 11% of the trials were described as “multiphase” programs.

UK landscape

The UK’s attractiveness as a study destination has been a subject of debate for years. The instigation was from a 2022 ABPI report suggesting the number of industry trials initiated in the UK per year had fallen 41% between 2017 and 2021.

A subsequent government review by Lord O’Shaughnessy — a member of the House of Lords and founder of medical consulting group Newmarket Strategy — concluded that the action was needed to make the UK more attractive.

In response, in December, the Labour government began debating regulatory changes it said would “strengthen the UK’s position as a global leader for innovative clinical trials.”

On April 11, the proposals were signed into law, triggering a 12-month rollout process that will “deliver the most significant update to UK clinical trials regulation in two decades,” according to the government.

One of the impending changes — the provision of an automatic authorization mechanism for certain studies — is likely to make the UK more attractive for drug research, according to the MHRA authors.

“Introducing automatic authorization for notifiable trials and some specific modifications will make trial approvals and modifications more efficient, enabling low-risk trials to receive MHRA authorization more quickly.

“This is aligned with Lord O’Shaughnessy’s recommendations suggesting that the MHRA should continue adapting its regulatory processes to ensure that the UK remains at the forefront of clinical trial innovation.”

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