Following a 2023 review of the UK clinical trial landscape, Lord James O’Shaughnessy, the former health minister highlighted major change since the report’s publication, but asked, “How sustainable is this new change in direction?”.
At the Outsourcing in Clinical Trials UK & Ireland conference, O’ Shaughnessy and other key opinion leaders said more changes are necessary to improve the UK’s clinical trial landscape.
The conference, taking place from 11 – 12 June, gathered clinical trial experts from across the world to discuss issues related to the clinical trial landscape and clinical operations in the UK and Ireland. At a panel discussing recent improvements to the UK clinical trial landscape, prominent figures detailed the key changes that could improve the ecosystem.
Professor Michael Lewis, the scientific director of innovation at the National Institute for Health and Care Research (NIHR), listed achievements since the May review such as changes to the Medicines and Healthcare products Regulatory Agency’s (MHRA) research framework and new National Health Service (NHS) guidance on managing research financing. However, all panelists stated that the UK still has space to evolve its clinical trial sector.
“It feels like we have turned a corner. That is a big achievement, but it is not enough,” says O’Shaughnessy. O’Shaughnessy published a final report on UK clinical trials landscape in May 2023, detailing five main areas for improvement in the country’s clinical landscape.
Dr. Andrew Ustianowski, the network director at the NIHR’s North West Regional Research Delivery Network, called attention to issues with the clinical trial timelines. He says that sponsors often bring their clinical trial plans to the UK too late, approaching the US regulatory system first, and then talking to UK regulators months later with plans directed to the US system. O’Shaughnessy said that this issue was partially due to a UK tendency to measure the success of the UK regulatory system against its past iterations rather than UK comparators. He offered the potential solution of a streamlined fast-track regulatory process across several global authorities. The former health minister says that several political parties have produced viable approaches to this, including the Labour and Conservative parties. For example, the Labour party’s “Prescription for growth” outlines such a plan.
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By GlobalData
Released in February, the Labour party’s report proposed the creation of a Regulatory Innovation Office (RIO) that unifies the Regulation Executive and the secretariat for the Regulatory Horizons Council. The new office would aim to “monitor targets for regulatory approval timelines, benchmarked against international comparators”, as per the report, amongst other responsibilities.
