ABPI says UK clinical trials sector ‘improving’

ABPI says UK clinical trials sector ‘improving’

There are glimmers of a recovery in the UK’s clinical research sector, with an uptick in the number of new studies being started, according to a new report.

The analysis, published by the Association of the British Pharmaceutical Industry (ABPI), is an encouraging sign but “is not yet enough to restore the UK’s global ranking on trials,” according to the trade organisation.

The data shows that the total number of industry clinical trials initiated in the UK per year rose marginally by 4.3%, from 394 trials in 2021 to 411 in 2022, although, the ABPI noted that this remains well below the 2015 peak of 690.

The UK has traditionally been a stronghold for clinical research, but pressure on the NHS and a slower-than-expected recovery after the pandemic have raised red flags about the long-term health of the sector, threatening the government’s vision of making life sciences a pillar of the national economy.

An ABPI report published last year found a 41% decline in new study starts between 2017 and 2021, prompting a review of the sector led by former health minister Lord James O’Shaughnessy that recommended sweeping changes to the way clinical trials are run and regulated in the UK and a target of doubling the number of people taking part in commercial studies in the next two years.

Since then, the Medicines and Healthcare products Regulatory Agency (MHRA) has started reforming the regulations governing trials, including new processes to hasten the set-up and approval of low-risk studies, which has typically taken longer in the UK than in other countries.

The new analysis also shows some positive developments in recruitment rates, with research organisations reporting a “moderate”15% increase year on year to just over 42,000 in 2022/23, although, once again that is short of the 58,000 peak in 2017/18.

Similarly, the average time taken to start trials has also contracted from 305 days to 194 days, down 36%, which the ABPI attributes in part to the introduction of a new model national contract that sets out standardised costings for most studies.

The UK’s global ranking is unchanged, despite the progress, sitting at fourth for phase 1 trials, sixth for phase 2, and tenth for phase 3 studies that “provide the NHS with the highest income, while also providing the most patents with free cutting edge medication,” said the ABPI.

It is calling for continued cross-government focus on speeding up clinical trial approvals and set-up, expanding UK capacity to deliver clinical trials, and improving visibility and accountability for clinical trial performance.

The trade body also says it remains important to boost the workforce, facilities, and infrastructure available for research to increase trial capacity.

“We are relieved to see that the sharp decline in industry clinical trials over the past years now shows signs of recovery. But this is not a champagne cork-popping moment,” said Janet Valentine, head of innovation and research policy at the ABPI.

“We recognise the huge amount of work by the NHS and government bodies that has gone into halting the steep decline, [but] we are still at the beginning of a long journey,” she added. “It’s therefore vital that the government maintains this momentum, taking further steps reversing the downward trend, to increase global confidence [in] UK life sciences.”