UK “keeping up momentum” on clinical trials review

Lord James O’Shaughnessy has welcomed the UK government’s official response to his review of commercial clinical trials, saying there have been a number of positive developments since it was published in the spring.

The government has committed to one of the key recommendations in the review – doubling trial recruitment by 2025, then doubling it again by 2027 – along with other headline commitments backed up by £121 million in funding over the next three years.

Those include a substantial reduction in the time taken for approval of commercial studies, with a target of 60 days, a comprehensive and mandatory national approach to contracting to cut out red tape, and the provision of ‘real-time’ data on commercial clinical activity in the UK due to roll out in 2025.

It also pledges a common approach to contacting patients about the opportunity to take part in research, and the establishment of clinical trial acceleration networks (CTANs) designed to speed up studies in areas like infectious disease vaccines, cancer, and dementia.

“The MHRA is performing much better, there is significant progress towards a national approach to contracting and costing, and most importantly the number of – and patients recruited to – industry-sponsored trials in the UK is growing again,” said Lord O’Shaughnessy in a LinkedIn post.

“But there is still much to do, and I’m incredibly grateful for the support and energy of everyone in the UK clinical trials sector who is trying to help us regain our globally-leading position.”

The O’Shaughnessy review was commissioned in response to an industry report that found a 41% decline in new study starts between 2017 and 2021, with a 48% reduction in participation in phase 3 trials that provide the NHS with the highest income.

The Association of the British Pharmaceutical Industry (ABPI) published a new report earlier this week which found signs of a recovery in commercial trials, with a 4.3% increase in the number run last year compared to 2021, although, the total number still fell well short of historical norms.

Among the improvements made since the review was first published is the elimination of a backlog in research approval applications by the Medicines and Healthcare products Regulatory Agency (MHRA), a new notification scheme for phase 4, and low-risk phase 3 clinical trials, and the removal of barriers to the acceptance of nationally agreed costs, according to newly-appointed Health and Social Care Secretary Victoria Atkins (pictured top).

She also promised new guidance on arrangements for identifying and contacting potential trial participants by the end of the year.

Atkins said the review showed “a welcome level of ambition,” adding that the government shares the desire to return the UK to its leadership role in commercial clinical research.

“We will work together across the UK to continue the timely enactment of this plan, implementing new UK performance indicators with immediate effect and progressing a range of commitments designed to enhance attractiveness as a destination for globally competitive life sciences research and our ability to deliver high-quality research funded by medical research charities and UK taxpayers.”