Putting patients at the centre of innovation starts with clinical trial access
A reliable and sustainable clinical trial system plays a pivotal role in supporting patients with unmet needs. The lack of a clear and open route to accessible investigational drugs risks compromising the health outcomes and well-being of patients with limited treatment options.
It is clear that the UK government appreciates the value of a thriving life sciences and research industry, with a particular focus on improving the function of clinical trials. The Future of UK Clinical Research Delivery, published in March 2021, was a bold and ambitious vision for clinical research in the UK, with a remit to unlock the full potential of clinical research delivery to tackle health inequalities, bolster economic recovery, and improve the lives of people across the UK by 2031. More recently in May 2023, Lord James O’Shaughnessy shared his findings from his independent review of the UK commercial clinical trials landscape, identifying ways to resolve key challenges towards improving the speed and efficiency of the UK clinical research ecosystem.
Despite this focus, the reality is that there has been a visible decline in the number of commercial clinical trials (i.e., those being funded by pharmaceutical and biotechnology companies). Last year, the Association of the British Pharmaceutical Industry (ABPI) reported that the number of participants recruited to industry clinical trials via the National Institute for Health and Care Research Clinical Research Network between 2017 to 2021 fell by 44%.1 In this same timeframe, the number of industry clinical trials initiated in the UK per year fell by 41%, resulting in a steep drop in the UK’s global ranking for the number of Phase III industry clinical trials, from 4th in 2017 to 10th in 2021.
While this decline was accelerated by the COVID-19 pandemic, compared to other countries, the resources available in the UK to set up trials and recruit patients post-pandemic continue to deplete.1 Consequently, we see a widening gap in the pressing need to provide new and effective solutions to patients with unmet needs and the availability of active clinical trials. If limited access to interventional industry clinical trials persists, diminishing availability to innovative treatments will result in a detrimental impact on patient health outcomes.
Evolving the clinical trial landscape
The O’Shaughnessy report notes the need for a step change in actions, recognises the necessity to support conversations around the research ecosystem between clinicians and their patients, and highlights the importance of increasing the profile of clinical trials among the general public, especially disadvantaged or marginalised groups.2
In many instances, patient populations are not aware of, informed about, or engaged enough in the research process to recognise that taking part in research could benefit their care. One of the shifts necessary to address this challenge is the inclusion of clinical trials as a part of routine ‘standard of care’, rather than on the fringes of NHS practice or professional guidelines.
This requires effective public access to information related to research, so people can easily indicate their interest in taking part in current or future studies. Both the National Institute for Health and Care Research (NIHR) and NHS England (NHSE) are developing the integration of Be Part of Research with the NHS App, which could provide a practical tool for people to easily register their interest. However, the current system lacks the appropriate infrastructure to link expressions of patient interest in research to appropriate clinical trials. While the NHS App holds promise, it is dependent on patients having adequate access to the internet to register, using the NHS App, and being engaged enough to actively register.
The O’Shaughnessy review further highlighted the lack of a single source of truth about clinical trials activity in the UK, making it even harder for clinicians, patients, and the public to know what is available, and how it is relevant for them. Too often, people hear about potential trials through word-of-mouth or closed networks. An industry-wide shift in our approach is needed, from a reliance on individuals learning about clinical trials and expressing interest of their own accord, to supporting the frontline workforce in bringing appropriate information more systematically to patients. We also need to enable a better distribution of research across geographies, communities, and care settings, to ensure equality of access for all patients across the entire UK.
Ensuring clinical trials are built around patients
The current landscape of clinical trials in the UK is at a pivotal juncture, with far-reaching implications for patient care. It is imperative that we innovate to create a more transparent environment and more accessible pathways to clinical trials for the public. Crucially, this effort must be underpinned by the meaningful involvement of patients and the public.
At Boehringer Ingelheim, for example, we continue to look for new and different ways to partner with the NHS and trials sites and to serve patients better, no matter who or where they are. Through a comprehensive review of our internal strategies, close collaboration with the NHS, and sharing of best practices, we strive to ensure that the patient perspective resonates throughout every stage of the research journey.
We believe patient and public involvement and engagement (PPIE) has a crucial role in putting patients at the centre of service delivery, to achieve a more sustainable, efficient, and inclusive healthcare system that works for patients and is fit for future. If done properly, PPIE in service transformation also offers a considerable opportunity to reduce health inequalities, in alignment with NHSE’s Core20PLUS5 ambitions.
With seemingly unprecedented levels of service transformation underway at every level of the health service and across multiple therapeutic areas, it is crucial to ensure the patient voice is not lost in the tumult and that they and the wider public contribute meaningfully to health system innovation.
Patient-centricity is now indisputably recognised as vital for healthcare delivery: patient involvement is mandated in NICE clinical guidelines and technology appraisals development,3 NHSE has published a toolkit on the importance of co-production with patients for quality improvement,4 and Integrated Care Boards (ICBs) have legal duties to involve patients and the public.5
It is therefore vital that we openly discuss the challenges of patient involvement, share learnings when we do things differently, and work together to accelerate progress.
- Association of the British Pharmaceutical Industry. 2022. NHS patients losing access to innovative treatments as UK industry clinical trials face collapse. Available at: https://www.abpi.org.uk/media/news/2022/october/nhs-patients-losing-access-to-innovative-treatments-as-uk-industry-clinical-trials-face-collapse/
- Lord James O’Shaughnessy. 2023. Commercial clinical trials in the UK: The lord o’shaughnessy review - final report. GOV.UK. Available at: https://www.gov.uk/government/publications/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review-final-report
- NICE. 2013. Patient and Public Involvement Policy. Available at: https://www.nice.org.uk/media/default/About/NICE-Communities/Public-involvement/Patient-and-public-involvement-policy/Patient-and-public-involvement-policy-November-2013.pdf
- NHS England. 2023. Co-production resource toolkit. Available at: https://www.england.nhs.uk/publication/co-production-resource-toolkit/
- NHS England. 2021. Building strong integrated care systems everywhere: ICS implementation guidance on working with people and communities. Available at: https://www.england.nhs.uk/wp-content/uploads/2021/06/B0661-ics-working-with-people-and-communities.pdf
About the authors
Vani Manja is Managing Director at Boehringer Ingelheim UK and Ireland.
Liz Walsh is Head of Clinical Development and Operations at Boehringer Ingelheim UK and Ireland.