Recommendations for building a UK fit for the future of clinical research

Meeting these challenges and taking opportunities will need to see both the private and public sectors working collaboratively to maintain the stability seen over the past several years and strengthen the UK’s life sciences ecosystem.

With this in mind – and against the backdrop of commitments made by the Government and the pharmaceutical industry as part of the Life Sciences Industrial Strategy and Sector Deals – the UK can build an ecosystem fit for the future of clinical research by:

1. Increasing investment in clinical research

The UK continues to rank highly in Phase I and Phase II clinical trials but falls behind other countries in late-phase clinical trials. With countries including China and Japan increasing R&D investment in life sciences research, it is important the UK maintains its world-leading position. Further opportunities exist to strengthen national capacity and enhance interactions between industry, academia and the NHS.

Commitments in the NHS Long Term Plan and Sector Deal 2 are an important sign of the Government’s commitment to providing a supportive environment.

Additionally, the commitment to increasing R&D investment to 2.4% of GDP and industry investment is key to achieving this.

Evidence shows that existing investment in clinical research can improve NHS performance[26] and patient outcomes[27,28], increase patient involvement in research and promote economic growth and productivity in the UK[29].

The impact of increased NHS investment in the UK’s clinical research environment would be significant with the following potential benefits.

• Greater equity in funding allocation to clinical research sites across the UK
  
  
• Higher NHS performance and delivery of care to patients
  
  
• Boosted opportunities for patient recruitment to clinical trials and involvement in research
  
  
• An enhanced innovation-ready workforce
  
  
• An improved UK research offer which welcomes highly skilled professionals, promotes collaborations and attracts private investment from around the globe Failure to invest in clinical research will ultimately jeopardise patient access to improved healthcare delivery and innovative approaches. This will diminish the UK’s current strength in clinical research.

2. Simplifying the process for setting up and running clinical trials

It is essential that high-quality, ethically responsible trials and other clinical studies, including Complex Innovative Design (CID) trials, are as easy to initiate and conduct as possible.

Processes need to be transparent, simple, harmonised, consistent with global standards, and sensitive to the needs of clinical trial sponsors. Commitments in the NHS Long Term Plan and Sector Deal 2 are an important sign of the Government’s commitment to improving the clinical trial landscape.

The HRA has a key role to play as the national governing body for health research in the UK and they are working with the MHRA on combined ways to speed up the approval process[30].

The NIHR provides the key governance and infrastructure for set-up of clinical trials, recruitment of patients and collection of data. Their work on building resources for commercial sponsors[31] and introducing a National Directive on commercial contract research studies[32] has been important for ensuring the UK remains attractive to commercial sponsors.

NHS England is crucial for ensuring that NHS bodies are committed to supporting clinical research, and that research is smoothly integrated into its day-to-day activities. Industry is well engaged with their ongoing work with NHS Improvement and NIHR on implementing a single contract review process[33] for commercial contract research. As the UK’s devolved health model creates a risk of fragmentation, this single contract review process has the potential to provide consistency across the devolved nations.

3. Building a workforce fit for the future

The design, delivery and management of clinical trials, as well as analysis of clinical trial data and meaningful patient involvement, all depend on a highly skilled workforce. These experts are the critical foundations for an attractive UK environment for clinical research. Collaborative working to ensure the necessary skills are supported and embedded across all NHS organisations is needed to improve the lives of patients in the short and long term.

If the UK is to deliver the clinical trials of tomorrow, it must act now to deliver a sustainable workforce. The current work of NIHR in supporting skills and training is valuable and we need to build on this. A sustainable workforce is one which is supported, in part, by opportunities for training on, and use of, innovative approaches and technologies. Alongside such opportunities: STEM education and skills need promoting at all levels; a robust forward-thinking skills system is required for major skills gaps in certain areas; multiple routes to meeting skills needs are required, including a skills-based immigration system which allows access to global talent.

The biennial ABPI Skills Survey has consistently identified recruitment challenges in areas such as clinical pharmacology. The 2019 survey[34] also showed the rapid emergence of high priority need for skills in immunology and genomics, driven by an equally rapidly evolving scientific environment.

In addition, data science emerged as a critical area, with skills in informatics, computational, mathematical and statistical areas in growing demand, particularly in interdisciplinary areas such as chemoinformatics.

These skills gaps must be addressed in order to fulfil our ambition to remain world-leaders in clinical trial performance, especially in therapeutic areas such as cancer and immunology.

The Clinical Pharmacology Skills Alliance[35], a collaboration between the ABPI, British Pharmacological Society, Health Education England and the Faculty of Pharmaceutical Medicine, is a prime example of a cross-sector initiative successfully addressing a specific skills gap.

The UK Government has recognised the importance of skills development, with commitments in the Life Sciences Industrial Strategy and Sector Deals. It is essential that ongoing and future initiatives address both current and anticipated future skills needs based on the changing nature of the development of medicines.

4. Harnessing the UK’s data infrastructure for medicines R&D

Healthcare data is key to clinical research. This includes the information on feasibility – the process of deciding if/how much the UK can contribute to specific trials – as well as the data being collected during the trial. Real-world evidence - patient data that are routinely collected outside trial situations - are also a potentially rich resource for understanding disease and the effects of treatment.

It is essential that there is clarity on the availability of health data in the UK to commercial bodies and on the uses to which they can be put in medicines development. The quality of the data and processes for accessing the data must be clear. This must be supported by appropriate governance, standards and regulations and a suitably skilled bioinformatics workforce.

Industry is engaged with Health Data Research UK which aims to facilitate partnership working across NHS organisations and other health data custodians within the Health Data Research Alliance and enable access to data through the Innovation Gateway and Digital Innovation Hubs.

5. Embedding patient involvement in clinical research

Patient involvement in clinical research is a key strength for the UK supported by an active patient charity sector and the NIHR. To embed this in clinical research, we need to ensure that there are practical tools available and that there is a systems-wide approach.

ABPI is working with the Association of Medical Research Charities (AMRC), NIHR and MHRA to provide leadership in this area.

6. Ensuring continuing high standards for transparency

Clinical research conducted for the benefit of the public and patients globally, must be transparent – a key pillar of any research activity. As well as scientific rigor, transparency measures ensure trials are appropriately registered and findings communicated to the general public (including researchers, healthcare professionals, patients and regulators).

Historically, compliance around registration and reporting of clinical trials has been poor, but over the past decade, transparency in industry has dramatically improved[36]. However, there is still more to do.

ABPI has identified three key areas in which clinical transparency can be improved, believing that research needs to be made available, accessible and understandable.

A key element of research transparency is registration and reporting on international databases and registries, in a timely manner, as governed by UK and EU legislation. In the UK, the Health Research Authority (HRA) ensures that those conducting research across non-commercial, charity and commercial clinical trials, comply with these regulations.

To achieve greater clinical trial transparency, the HRA’s draft strategy[37], proposes how it can improve registration and reporting in clinical research. ABPI supports this draft strategy and continues to work with the HRA to improve transparency in commercial clinical trials. Any UK specific initiatives should be practical to implement and not duplicate work for clinical trial sponsors. In addition, any UK initiatives should be in line with international standards such as the WHO standards for clinical trial registries[38].

Once made available, research should be accessible, through user-friendly registries and databases, and open access journals where research findings do not sit behind pay walls. ABPI is working with key stakeholders across the sector to explore the pharmaceutical industry’s perspectives and policy needs relating to open science, with a focus on open access publishing.

Lay communication is an essential part of clinical research. Findings from clinical trials must be communicated in a way that is understandable to the general public – a process greatly improved by patient and public engagement.

The EU Clinical Trials Regulation 536/2014 (Article[37]) requires clinical trial sponsors to provide summary results of clinical trials in a format understandable to laypersons[39]. These layperson summaries will be made available in a Clinical Trials Information System. Although the Regulation was adopted and entered into force in 2014, the timing of its application depends on the development of this system.

Looking forward, the ABPI will be continuing efforts to promote the accessibility and understanding of clinical research, exploring issues such as open access publishing and preparing for the new requirements for lay summaries, under the EU Clinical Trials Regulation No 536/2014.

The UK Government acknowledges the need for change and has advocated for greater research, governance and ethics[40]. ABPI welcomes this commitment and will continue to work with industry and key stakeholders to improve clinical trial transparency.

7. Securing a future UK-EU relationship on medicines and research

UK clinical trial activity has remained strong following the Brexit referendum result, based on the figures in this report from shortly after the result.

However, continued uncertainty about the future UK-EU relationship undermines the attractiveness of the UK as a destination for clinical research. Because clinical trials are conducted over several years, any impact on activity will not be seen in datasets for another few years.

However, it is clear that continuing uncertainty threatens to undermine the UK’s attractiveness to industry as a destination for clinical research. The UK’s life sciences industry has identified four areas for the UK to secure for a future UK-EU relationship, to ensure the UK research environment continues to thrive[41].

These include, research stability; ability to trade; a common regulatory framework and access to the best talent – all of which impact the UK’s clinical research environment.

As UK research is a complex ecosystem, it relies on a stable science and research environment, supported long-term by cross-sector global investment and collaboration. EU framework programmes, such as Horizon Europe, drive world-leading research, with the EU a global leader in life sciences R&D.

Currently the UK is highly influential in both the design and delivery of EU R&D programmes. Anything less than full participation and influence in EU programmes, would result in an unsatisfactory position for UK life science R&D and UK patients.

Without the ability to influence the design of research programmes, leading researchers are likely to move out of, or not move into, the UK and this loss of globally recognised and highly skilled researchers will drastically undermine the UK’s research base.

If a diminishing ability to influence the design of EU R&D programmes remains after the UK leaves the EU, it will be critical for the UK Government to develop and deploy alternative and ambitious research and innovation programmes.

This will require significant change in the current R&D funding architecture and will be essential to reach the R&D investment target of 2.4% of GDP and retain its status as a world-leader in R&D.

The EU has provided much of the scientific, regulatory and trade infrastructure for the pharmaceutical industry in the UK through the European Medicines Agency (EMA).

Securing any continued international R&D investment and collaboration between the UK and the EU, will largely depend on the regulatory framework the UK has in the future.

In particular, participating in the EU regulatory framework for medicines and having continued access to the EU clinical trials database, are critical for ongoing future clinical trials in the UK.

Regulatory cooperation is essential for ensuring medicines continue to be researched, developed and delivered to patients in the UK and the EU.

To maintain a thriving UK research environment, particularly clinical research, industry need certainty in order to plan and decide where to invest.

As long as there is uncertainty regarding the timelines around Brexit and what the future relationship with the EU will look like, pharmaceutical companies will find it a challenge to make decisions to invest in the UK.