JPM: Is the UK's clinical trials sector turning a corner?

New data from the UK medicines regulator has shown an increase in clinical trial activity in the country, after years of decline, which it says shows that the promise of reforms is already starting to have an effect.

The MHRA has reported that applications to start studies rose 9% between January and November last year, compared to the same period of 2024, with growth strongest in early-stage studies.

The data was revealed as a UK delegation headed by MHRA chief executive Lawrence Tallon attended the JPM Healthcare conference in San Francisco – flying the flag for the UK sector – and has been called an "encouraging sign" by the Association of the British Pharmaceutical Industry (ABPI).

According to the regulator, the highlights of the data include a 16% increase in healthy volunteer studies, while first-in-human studies were up 5%. It also pointed to a 7% increase in studies being run in the UK for the first time, calling it "a sign of growing international confidence in the UK as a place to launch new research."

Arguably, most encouraging is a 75% increase in requests by company sponsors for advice meetings with the MHRA, to make sure study protocols are designed correctly from the outset and avoid costly delays later.

"These impressive gains have been made within the limitations of the current regulatory framework," said the MHRA, adding that a package of significant changes will be delivered when new clinical trial regulations take effect from April.

In its update, the agency said that a fast-track notification route – which will help companies get studies up and running more quickly – will be implemented later this year and ensure patients can benefit from new treatments sooner. It anticipates that around 20% of studies will move onto the fast-track, which will remove some of the red tape around lower-risk studies whilst freeing up capacity at the agency to assess other, more complex studies.

Among other changes, the MHRA will also introduce a 14-day assessment route for phase 1 trials, which it says will restore a rapid pathway for first-in-human testing of new medicines. It will also allow safety data from overseas studies to be considered and introduce new systems to assess computer simulations, such as in silico trials, that can be used to predict how new medicines may behave before they are tested in patients.

"Clinical trial sponsors are clear about what they need: speed, clarity and flexibility," said Tallon. "New rules will make it simpler to start lower-risk studies, strengthen support for early-stage research and embrace modern approaches, including adaptive trial designs and computer model simulations, while maintaining patient safety."

The package of measures is designed to deliver on the UK government's pledge to cut the time from trial application to first participant from around 250 to 150 days, by delivering regulatory decisions within 60 days, opening sites to recruitment within 60 days of approval, and recruiting the first patients within 30 days of the trial opening.

Alarm bells have been ringing about the state of the UK clinical research sector for several years, after a report from the ABPI found a 41% decline in new trial initiations between 2017 and 2021.

Just over two years ago, a report by Lord O'Shaughnessy on commercial clinical trials in the UK found that the country was slipping behind other countries as a hub for clinical research, and made a series of recommendations to reverse the decline, some of which are starting to be put into place by the MHRA.

In December, a report from the NHS's Health Research Authority found that there had been a 17% increase in the number of people participating in trials to more than 450,000 in 2024/25 compared to the prior 12-month period, although, the number participating in commercial trials fell by around 25%.

Commercial studies accounted for just over 3% of the total number of international studies being run and, in its analysis, the ABPI said patient recruitment into trials in 2024/25 was at the lowest level since 2017/18.

In a statement, the ABPI's head of innovation and research policy, Dr Janet Valentine, said: "Speed and predictability in regulatory approvals are critical to setting up clinical trials and will be essential to meeting the government's ambition of a 150-day set-up. We therefore welcome the MHRA's efforts to accelerate regulatory processes. These improvements must be sustained, so the UK can consistently deliver rapid trial set-up and timely patient recruitment."