As I begin to research key topics and themes to include in our upcoming COG UK conference (2024), I've taken time to reflect on the changing mood of the UK's Clinical Trial sector. Since our last edition in February 2023 the O’Shaughnessy Report has dominated headlines with recommendations to improve and rebuild the UK's Commercial Clinical Trials.
Historically, the UK has been seen as an attractive location for running clinical trials, thanks to its world-leading academic research and public health infrastructure. However, in recent years the clinical trial landscape in the UK has become more precarious with the initiation and execution of trials becoming more complex and challenging for sponsors.
“Commercial clinical trials are absolutely vital to both our UK life sciences sector and widening NHS patient access to innovative medicines all across the UK.” George Freeman, Minister for State at the new Department for Science, Innovation and Technology, UK Government
On the positive side, the UK continues to offer access to expert investigators and large patient populations across a broad range of therapeutic areas. The NHS is a centralized healthcare system which allows for efficient patient recruitment and data collection. The UK also has a strong clinical research tradition and a regulatory framework that is aligned with key international markets. Major government investments in genomics and biomedical research help position the UK at the forefront of medical innovation. In May 2023, Jeremy Hunt, the UK Chancellor of the Exchequer announced a £650 million investment into the UK's Life Science sector. As well as significant investment into the NHS, this included £121 million to improve commercial clinical trials, and £154 million to increase the capacity of the UK’s biological data bank
Running clinical trials in the UK has recently become more challenging in some respects. The process of obtaining regulatory and ethics approvals has become lengthier due to increased scrutiny and complex requirements, and resourcing issues at regulatory bodies. The UK's departure from the European Union raised uncertainties around recruiting patients from the EU and data sharing. Lockdowns and strains on the NHS during the COVID-19 pandemic also caused significant disruption to many trials. Since the COVID-19 pandemic the clinical trial sector has been slow to bounce back due resource and capacity issues in the NHS.
“The number of commercial clinical trials initiated in the UK continues to decline” An opportunity for growth: Clinical research in the UK, The Association of the British Pharmaceutical Industry
There are also financial pressures - the UK government has aimed to cut the bill for assessing new drugs, to remain competitive in the global landscape. The UK must work to remain cost-competitive compared to emerging clinical trial locations such as Eastern Europe, South America, and Asia.
However, it’s not all doom-and-gloom… Steps are being taken to streamline bureaucracy and reduce logistical barriers to UK clinical trials. The Health Research Authority has introduced an online form to simplify ethics applications. The Association of the British Pharmaceutical Industry is working with the government to clarify regulations and processes. In May this year, the Lord O’Shaughnessy Review into Commercial Clinical Trials in the UK was published, with the recommendations expected to double the numbers of people taking part in commercial clinical trials in the next 2 years, and double it again by 2027.
“..the government should aim to double the numbers of people taking part in commercial clinical trials in the next 2 years, and double it again by 2027.” - Lord O’Shaughnessy review, May 2023
Unfortunately, many trial sponsors who would traditionally have run their trials in the UK are now looking at international markets. This is amongst other challenges, due to extended regulatory approval/ update timelines making trials increasingly expensive, as well in some cases the drop-out of enrolled patients due to no long qualifying to the trial’s criteria.
The future success of UK clinical trials relies on the ability to leverage strengths like scientific expertise, while innovating to offset emerging challenges. Important priorities include sustaining investment in cutting-edge research, integrating healthcare data, developing expertise in key growth areas like cell and gene therapies, and building strong collaborative networks across Europe and internationally.
Clinical Outsourcing Group UK (COG UK), our flagship conference is taking place on 20th & 21st February 2024 in London, UK. This event attracts the UK's clinical research ecosystem with attendees from Biopharma, Public Health, Academia, and Full & Functional Service Providers.
Reach out to me directly at firstname.lastname@example.org if you wish to contribute to the programme.
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