ABPI urges decisive action to rescue UK clinical trials

The Association of the British Pharmaceutical Industry (ABPI) has reported a significant decline in the number of UK industry clinical trials being conducted, constituting a “clear and serious” threat to the long-term future of industry clinical research in the UK.

This finding appears in a report, Rescuing patient access to industry clinical trials in the UK, which was published on 20 October 2022. In its report, the ABPI recommends a number of short-term measures to regain the UK’s competitiveness in industry clinical research.  (Long term recommendations were set out in the ABPI’s report this time last year Clinical research in the UK: An opportunity for growth.)

The ABPI has drawn on similar data and metrics from the most recent Life Sciences Competitiveness Indicators report (see further here). Its key findings include:

• A 44% decline from 2017/18 to 2021/22 in patient access to industry research, with a significant drop in participants recruited to industry clinical trials on the National Institute for Health and Care Research Clinical Research Network.
• It blames consistently slow and variable study set-up timelines as driving the decline, with an increase in the median time between a trial applying for regulatory approval and that trial delivering its first dose to a participant rising to 247 days – placing the UK 7th among comparator countries.
• The number of clinical trials in the UK in turn fell by 41% between 2017 and 2021, with pharmaceutical companies increasingly placing their trials in other countries.
• The UK has fallen from 4th in 2017 to 10th in 2021 for Phase III industry clinical trials.

The ABPI warns of serious consequences of reduced access to interventional industry clinical trials – in particular for patients with limited treatment options in routine care, such as people living with rare diseases. Conversely, if the trend can be reversed and the UK can preserve and grow the UK life sciences sector, the ABPI cites data suggesting significant benefits, including:

• An additional £68 billion of GDP for the UK economy from increased R&D investment
• Additional annual NHS revenue of £165 million and £32 million in cost saving (if recruitment to trials in the UK were to rise to be on a par with Spain)
• A 40% decrease in total attributable burden of disease

The ABPI urges 11 specific actions by Government and NHS England in the short term to stabilise and reverse the decline and underlines the need for all stakeholders to act decisively. The actions are grouped under the headings of (i) prioritising interventional industry clinical trials; (ii) improving set-up processes for industry clinical trials; and (iii) leveraging industry trials to boost NHS research capacity and culture.  Key recommendations include:

• Accelerating prioritisation of the set-up and delivery of interventional clinical trials of new medicines and vaccines
• NHS England and devolved administrations establishing mechanisms to improve coordination between companies and study sites
• The introduction of a 60-day maximum timeframe for costing and contracting of industry clinical research
• NHS England working to ensure all NHS Trusts in England are committed to adhering to prices generated by the interactive Costing Tool for industry clinical research
• NHS England working with the pharmaceutical industry to co-develop research guidance and research performance metrics for Integrated Care Systems
• NHS England incorporating best practices in research finance into its upcoming research guidance for Integrated Care Systems

In response to the ABPI’s report, the British Medical Association (BMA) urged the government to act decisively and “stave off this existential threat to the UK life sciences sector and healthcare ecosystem”.  The Chair of the BMA’s medical academic staff committee, Professor David Strain, stated:

“The worrying decrease in the number of clinical trials in the UK in recent years is further evidence of the UK’s declining dominance as one of the world’s leaders in medical research. This highlights the importance of maintaining the closest possible relationship to our partners in the European Union, as a system of separate regulatory arrangements is placing us at a disadvantage.”

Key takeaways

• This report is a strong reaction from the UK industry body in response to the current UK clinical trials landscape. The ABPI views clinical trials as an important indicator of the UK’s life sciences sectoral performance overall when compared with regulatory peers, and this Report echoes its dismay at the UK’s performance in the Life Sciences Competitiveness Indicators report 2022.
• The clinical trials framework is also of vital importance to other current UK government life sciences priorities, for example, clinical trials are clearly central to the five year genomics strategy recently outlined by the UK government, see further here.
• The regulatory backdrop here is important and the timing of the recommendations is apt. The UK is yet to publish the outcome to its clinical trials consultation from earlier this year (see our analysis here), and any potential  divergence from the EU’s Clinical Trials Regulation (which came into force post-Brexit) may become apparent as time passes.