Slow recruitment still hitting UK trials, says pharma
Despite efforts to improve the environment for commercial clinical trials in the UK, the sector is still facing headwinds like low recruitment rates and rising costs.
That is the message from the latest annual report (PDF) on clinical trials from the Association of the British Pharmaceutical Industry (ABPI), which says that patient recruitment into trials in 2024/25 fell 25% on the previous year to just over 19,000, and is now at the lowest level since 2017/18.
The disappointing finding comes more than two years after the 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.
That included a target of quadrupling participants in commercial clinical trials by 2027, which would advance medical science, but also bring significant investment into the country. The new ABPI report suggests that is looking like a pipe dream.
According to the ABPI, companies state slow set-up times for studies and significantly lower recruitment targets for UK sites compared to other European countries as the main reasons for the decline.
That assessment also runs counter to comments made by O'Shaughnessy earlier this year, who said the UK had turned a corner in trials and was once again taking a "global lead," helped by the Medicines and Healthcare products Regulatory Agency (MHRA) implementing reforms to speed up trial approval times.
According to the new report, while overall participation in clinical trials in England has increased since the pandemic, only 3.4% of participants in 2024 were recruited into industry trials in the NHS.
The government has implemented measures to try to improve matters, and has committed to reducing clinical trial set-up times 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.
However, while the regulatory decision target is being met, only 27% opened for recruitment on time, and just 41% recruited their first patients within the 30-day allocation.
It is not all doom and gloom, however, and on the positive side there was a 36% increase in the number of new industry trials initiated to 578, and the UK climbed from eight place to sixth place for global phase 3 trial starts.
That said, competition with other countries remains intense, and Spain is now topping the list for European locations while China is "continuing to expand its global dominance in clinical trials," according to the ABPI.
"Industry clinical trials bring widespread benefits for patients, the NHS, and the economy," said Dr Janet Valentine, the trade organisation's head of research and innovation policy.
"While the increase in the number of industry trials initiated in the UK is positive, the low number of patients taking part is selling UK patients short of the opportunity to participate in studies of the latest therapeutic innovations," she added.
The report makes a series of recommendations to get the recovery back on track, topped by a concerted effort by investigative sites to "set and meet higher recruitment targets."
It also wants to see executive-level accountability for clinical trials across the NHS, and strenuous efforts to make the most of the £300 million VPAG Clinical Trials Investment Programme, a public-private partnership announced last year to improve UK commercial trials delivery.
