Former health minister Lord James O’Shaughnessy said the UK is “building from a position of strength” as he assessed commercial clinical activity 18 months after his landmark review.

Speaking at the Future of UK Life Science Regulation 2024 conference on 6 November. O’Shaughnessy highlighted positive strides made in the country’s clinical research sector. He went on to outline the major remaining issues limiting clinical trials in the UK and advocated for data transparency, a common contracting model, and increased decentralisation of trials to further improve the country as a clinical trials hub.

At the event, which was organised by the UK Bioindustry Association, O’Shaughnessy said, “The UK market has sorted itself out and is ready to grow again”, noting in particular £1.3bn a year now spent on the National Institute for Health and Care Research (NIHR), up 4.2% from 2022/2023, and over a million subjects currently enrolled in clinical trials across the country. He pointed to regulatory continuity as the Labour government entered office in 2024 as a key factor in the success of regulatory reform.

However, O’Shaughnessy noted several remaining factors holding the sector behind. Despite encouraging regulatory reform by the government , he drew attention to “site-level” problems, chiefly difficulties in trial initiation and early recruitment. “What we need to focus on are interventional trials,” he said.

O’Shaughnessy noted several measures in his talk to tackle remaining weaknesses in the UK’s commercial clinical sector. Among these was radical transparency of clinical data across organisations and making this data readily available to patients, which he stated could boost trial participation by the public.

He also expressed interest in a common contracting model for contract research organisations (CROs) as employed in Catalonia, Spain, a leading region for clinical trials, and pointed to trial decentralisation as another route to increase the number of trial participants. To this end, O’Shaughnessy pointed to recent FDA guidance on decentralised clinical trials as a useful reference for changes to domestic regulation.

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Discussing the future developments in the UK clinical space, O’Shaughnessy highlighted the country’s lead in techbio investment, attracting more of this funding than the rest of Europe combined. Fostering this advantage would offer a promising route to reduced trial and drug discovery costs, he said. Conversely, O’Shaughnessy noted the country’s relative scarcity of public-private partnerships in the clinical space, despite a thriving site management organisation (SMO) market, and saw potential in collaborations such as that between Eli Lilly and Health Innovation Manchester.