O'Shaughnessy says UK clinical trials sector is on the mend

After losing ground in commercial clinical trials in recent years, the UK has now turned a corner and is once again taking a "global lead," according to former health minister Lord James O'Shaughnessy, who published a landmark report on the sector two years ago.

On the occasion of International Clinical Trials Day (20th May), O'Shaughnessy said that the UK's development since 2023 has been "remarkable," helped by the Medicines and Healthcare products Regulatory Agency (MHRA) implementing reforms to speed up trial approval times.

"Despite its global reputation for excellence, by 2023 trial approval set-up times had slipped badly," he said, but the MHRA is "now delivering consistently good approval times while introducing further reforms to add speed and flexibility to the process."

In 2023, there was real concern about the UK's slide down the rankings of clinical research locations, with figures from the Association of the British Pharmaceutical Industry (ABPI) suggesting there had been a 41% decline in new trial initiations between 2017 and 2021.

Among the targets for reform in O'Shaughnessy's review was the lengthy and bureaucratic process for set-up and approval of trials compared to other countries, often taking upwards of six months to complete, which UK Prime Minister Keir Starmer wants to reduce so trials can be up and running within 150 days.

MHRA chief executive Lawrence Tallon said that changes to regulations since then represent the most significant update to the UK clinical trials landscape in 20 years, but pledged to do more.

"The UK is already a research powerhouse driven by innovation, with one in eight trials in the UK testing treatments in humans for the first time," he said. "But we want to go further [with] reforms that will address the research sector's need for a more risk-proportionate regulatory framework for clinical trials and will help get cutting-edge new treatments to the NHS as quickly as possible."

Among the measures introduced by the MHRA and Health Research Authority (HRA) are a pilot inclusion and diversity plan to offer guidance on how to make sure studies represent the patient populations they are designed to treat.

As of today, the MHRA is also launching a six-week consultation on the use of real-world data (RWD) for external control arms of clinical trials, which has the potential to help accelerate the approval of treatments, especially in cases when randomised controlled trials may not be ethical or feasible.

The agency said sources of RWD can include electronic health records (EHR), disease and patient registries, and patient-reported outcomes (PRO) data.

New UK clinical trials regulations designed to introduce an agile, innovative and patient-centric regulatory framework for clinical trials were debated in Parliament in February. There will be a 12-month implementation period for the MHRA to update processes and procedures and to publish new guidance to prepare trial sponsors for the new regulations before they come into force.

A recent paper published by the MHRA in the British Journal of Clinical Pharmacology included an analysis of more than 4,600 clinical trial submissions between 2019 and 2023 to provide a benchmark to gauge the impact of its reforms.

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