Why the UK government must continue investment to boost UK clinical trials industry
On Thursday 4 July, the UK public voted overwhelmingly for a change in leadership and a new Labour government was formed. Now, as the new administration gets its feet under the table and begins to commit to its plans to ‘change Britain’, we urge them not to deprioritize the need to invest in the future of clinical research. The clinical trial industry is the largest contributor to pharmaceutical research and development (R&D) in the UK and plays a pivotal role in advancing science, improving patient care and supporting the economy. Despite this, the industry has been in decline for the last several years. The previous government recognised this and took commendable steps to address the issue. Lord O’Shaughnessy was appointed to lead a review to help transform the UK’s commercial clinical trial environment, which resulted in clear recommendations to help revitalize and grow the sector. As a company, we now look to the new government to commit to seeing through these recommendations, which were published last year, and continue to build on the progress already made. The previous government, for example, had pledged £121 million to help deliver key ‘headline commitments’ from the report and welcomed Lord O’Shaughnessy’s ambition to get clinical trial activity back to pre-pandemic baseline levels, and then double that by 2027.
Key priorities for R&D growth
As part of the much-needed push to make the UK a highly desirable location for clinical trials, we particularly want to see:
- legislation around diversity in clinical trials to make it a requirement rather than optional
- diversity data reporting becoming mandatory for clinical trials to ensure progress
- a continued commitment to streamline the process of clinical trial approvals
- an exploration of the use of artificial intelligence (AI) in clinical trials; its benefits and challenges
- education programs and public campaigns to ensure people understand what clinical trials are and what they involve, to demystify the process and encourage more people to consider participating.
Increasing diversity in clinical trials
Diversity in clinical trials is essential for developing treatments that are effective across different patient populations. The world we live in is more diverse than ever, which gives us a cultural richness and unique opportunities to learn from one another. However, this is sadly still not always reflected in clinical studies. As an industry, we agree that for treatments to be effective, R&D must embrace diversity. However, we know that protocol design can inadvertently exclude certain groups, such as the LGBTQIA+ community. It is vital that this is addressed. For clinical trial patient recruitment, this involves a thorough assessment of the patient populations eligible for each treatment or treatment combination. We must then ensure a mix of participants are recruited, taking into account factors such as age, ethnicity, socioeconomic background and gender. We know that diversity and inclusion is increasingly seen as a priority for the life sciences industry, but there is still a way to go to achieve true and sustained diversity across all studies in the drug development pipeline. To help move this along, the government must introduce legislation to mandate diversity in clinical trials, making it a requirement to record and report this data for every study.
Understanding and optimizing AI
Artificial intelligence has huge potential in the healthcare space to help diagnose conditions earlier, analyse test results quicker and support decision-making when it comes to treatment plans and patient care. The newly elected government has promised to ‘harness the power of technologies like AI to transform the speed and accuracy of diagnostic services, saving potentially thousands of lives’. We applaud this commitment, but caution that, just like any new treatment must undergo rigorous testing through the clinical trial process, AI tools must receive the same scrutiny before widespread implementation to validate their accuracy and effectiveness. Investment in mass testing of these technologies is as pivotal as investing in other equipment. Hand-in-hand with this, the government must also consider how AI should be regulated. In the European Union (EU), the AI Act, the first-ever legal framework on AI worldwide, will become fully applicable by 2026. The Act sets out different risk levels for different AI products, which determines how much regulation they will face. Although the UK is no longer part of the EU, we expect this Act will be influential in setting our approach to AI regulation.
Accelerating approvals for clinical trials
The Lord O’Shaughnessy review acknowledged that ‘clinical trial set-up and approval processes in the UK are slow and bureaucratic, especially compared to other countries’. We have known for several years that ‘red tape’ has slowly been strangling the clinical trials industry by causing what can often be lengthy delays. This was made worse by the COVID-19 pandemic, which created a backlog for regulators. The previous and current governments both acknowledged this challenge. In November 2023, the Department for Health and Social Care committed to reducing the approval time for all commercial clinical trials to 60 days and reported that the Medicines and Healthcare products Regulatory Agency (MHRA) had been successful in doing this for all studies within this timeframe. Meanwhile, just a month earlier, the Labour Party announced its intention to create a new Regulatory Innovation Office (RIO) to hold regulators, such as the MHRA, accountable for delays in decision-making. We welcome the idea of the RIO to ensure regulators continue to meet their commitments in a timely and efficient manner and urge Sir Keir Starmer and his government to continue looking at ways to streamline the regulatory process for clinical trials in the UK. If we can speed up this decision-making, the country should be able to run more clinical trials, which will then deliver better access to the latest treatments for patients.
Demystifying clinical trials through education
A significant barrier to clinical trial participation remains a lack of public understanding and trust. Part of this is due to long-standing misconceptions about clinical trials, which have been fueled by misinformation and skepticism towards science – a phenomenon we particularly witnessed on social media during the COVID-19 pandemic. Education is the key to changing public attitudes. Ideally, this education would be integrated into the school curriculum. The UK currently has a STEAM (science, technology, engineering, arts and mathematics) education strategy to promote scientific thinking and creativity, but this fails to include any teaching about clinical research. Given that this is the largest piece that contributes to the country’s economy, this is a major omission. Wider public awareness campaigns are also required to change people’s mindset towards clinical trials and drug development. We hope the government will consider ways to do this, such as partnering with social media companies to reach, inform and engage with as many people as possible.
Investing in R&D for the future of the NHS
The new Health and Social Care Secretary, Wes Streeting MP, claims the NHS is ‘broken’ and a new approach is necessary to make it fit for purpose in 2024 and beyond. The government has promised investment and reform. For the government’s plans for the NHS to be successful, it must prioritize investment in pharmaceutical R&D and embrace the opportunity to work in partnership with others to boost medical innovation and help ensure we can all enjoy a good quality of life. We are heartened by the appointment of Sir Patrick Vallance as Science Minister. As a former Government Chief Scientific Advisor and clinical researcher, we are sure Sir Patrick will work hard to ensure science, including clinical trials, and the impact it has on wider society is appreciated and valued. We hope to see the Department for Science, Innovation and Technology, of which Sir Patrick is now a part of, the Department of Health and Social Care and the life sciences sector working hand-in-hand to continue the vision of Lord O’Shaughnessy in transforming the landscape for clinical trials in the UK. By working together, we can accelerate medical innovation, improve patient outcomes and ultimately bolster the health of the economy, contributing to the country’s growth.
Innovative Trials is a prominent international company specializing in patient recruitment and retention for clinical trials. Boasting 14 years of experience, we provide three fundamental solutions in this domain:
- Site Enrollment Optimization, facilitated by ‘boots-on-the-ground’ local patient recruitment experts operating in more than 70 countries
- Materials and digital advertising, and
- Navigator, a one-to-one support solution for patients, caregivers and sites.
With expertise in over 400 trials, 25 therapeutic areas, and more than 90 conditions, we are a trusted and seasoned partner to many major pharmaceutical companies, Contract Research Organizations (CROs) and biotechnology companies. Get in touch to find out how we can support your clinical research.