One year after the UK’s biggest overhaul of clinical trial regulation in 20 years, is the UK on its way to becoming a first-class choice for commercial clinical research?
Legislative changes to streamline clinical trial approvals were announced by the MHRA in March 2023, promising the biggest overhaul of UK regulation in 20 years to facilitate the UK becoming a first-class choice for biopharma companies conducting clinical research.
Promising shorter and more flexible timelines than EU regulators, the proposed changes followed recommendations proposed in the independent review conducted by former health minister Lord James O’Shaughnessy for the MHRA, NHS, HRA and NIHR to address key challenges in the UK commercial clinical trials environment. Of the 27 recommendations proposed, five initial headline commitments were announced, including a commitment to substantially reduce the time taken for approval of commercial clinical trials and to deliver a national approach to contracting to facilitate faster start-up times.
Improvements to the commercial clinical trial environment in the UK were announced during a challenging time for the biotech industry, with a post-pandemic downturn in funding exacerbated by a challenging economic environment. Additionally, the MHRA struggled to deliver its promised accelerated timelines in late 2023, and experienced significant delays. However, despite the challenges, the MHRA continued to push ahead and shared frequent updates on progress to ensure transparency as they addressed the situation.
In October 2023, the MHRA announced a new streamlined notification scheme to reduce processing time to 14 days for the lowest-risk phase III and IV trials, estimated to support 20% of UK initial clinical trial applications. For the remaining 80%, the MHRA aims for a 60-day turnaround time for all approvals to bring innovative new medicines to UK patients more quickly. An ABPI report published in November 2023 demonstrated that the UK’s clinical trial industry was showing signs of improvement even prior to the MHRA’s announcement, with an increase in both initiated clinical trials and clinical trial recruitment compared to the previous year (2021 to 2022).
The MHRA figures announced in April 2024 showed a 52% increase in CTA applications compared to the previous month, with 100% of initial applications and amendments assessed within the statutory timelines. The average timeframe for review came in at 27 days, 3 days below with 30-day statutory timeframe, second review timelines on target at 16 days, and CTA amendment reviews completed within 25 days – 10 days faster than the MHRA’s statutory timeframe for review.
Gabrielle Brill, Regulatory Affairs Manager – Clinical Pharmacology at Simbec-Orion comments:
“Simbec-Orion works with clients to deliver competitive timelines. Utilisation of Simbec-Orion’s in-house key trend analysis, which comprises of all queries raised by REC/MHRA over the past 10 years shows a consistent decrease in the number of queries generated during initial review, with an average of 1-2 queries per REC application in the last 3 years and an average of 4 queries per MHRA application in last 3 years. These low query rates result in a more rapid response time to address queries and subsequently a quicker issue of the final approvals. In addition, utilising our key trend analysis reduces the risk of downstream amendments.”
Faster approvals and a commitment to ensuring the UK is an attractive choice for commercial clinical trials comes as biotech funding begins to show signs of recovery from the 2021-2022 decline (IQVIA, 2024). Analysis of clinical trials data from Global Data indicated revealed 43% of healthy volunteer studies were initiated by biotech companies in 2022, with first-in-human trials accounting for a large proportion of studies initiated. Given 40% of new launches in 2023 were first-in-class, and 54% of drugs launched in the last 5 years had Orphan Drug Designation (IQVIA, 2024), support for innovative drug development has never been more important. For biotech companies seeking to conduct clinical trials in 2024, the MHRA has long supported complex innovative trial designs (ABPI, 2018, Wydenbach, 2019), enabling faster and more efficient clinical trials than ‘traditional’ approaches to clinical trials. The commitment of UK regulators to provide a welcoming and efficient environment to conduct clinical research, combined with funding of £121 million to improve the clinical trial infrastructure in the UK shows that for biotech getting back to business in 2024, the UK is a strong contender for the future of commercial clinical development.
ABPI (2023) Getting back on track: Restoring the UK’s global position in industry clinical trials, 17 November [online] https://www.abpi.org.uk/publications/getting-back-on-track-restoring-the-uk-s-global-position-in-industry-clinical-trials/
ABPI (2018) Complex Innovative Design (CID) Trials – A Report From The Ministerial Industry Strategy Group Clinical Research Working Group, September [online] https://www.abpi.org.uk/media/bnxbacl2/cid-trials-misg-crwg-paper-for-ols-sept-2018-v2.pdf
DHSC Media Team (2023) What we’re doing to speed up clinical trials in the UK , Department of Health and Social Care, https://healthmedia.blog.gov.uk/2023/11/22/what-were-doing-to-speed-up-clinical-trials-in-the-uk/
IQVIA (2024) Global Trends in R&D 2024: Activity, productivity, and enablers, 22 February, [online] https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/global-trends-in-r-and-d-2024-activity-productivity-and-enablers
MHRA (2024) MHRA Performance Metrics: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments [online] PowerPoint Presentation (publishing.service.gov.uk)
MHRA (2023) MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years [online] https://www.gov.uk/government/news/mhra-to-streamline-clinical-trial-approvals-in-biggest-overhaul-of-trial-regulation-in-20-years
Wydenbach, K (2019) Spread the word – clinical trial regulators do not bite!, 15 March https://medregs.blog.gov.uk/2019/03/15/spread-the-word-clinical-trial-regulators-dont-bite/