What is happening in clinical research in the UK and how are recent updates relevant to me?

Posted on: Wednesday 28 June 2023
Author: Dr Kirsty Wydenbach et al

How to cite: Wydenbach, K. et al (2023), ‘What is happening in clinical research in the UK and how are recent updates relevant to me?’, Faculty of Pharmaceutical Medicine, 28 June 2023. Available at: [https://www.fpm.org.uk/blog/what-is-happening-in-clinical-research-in-the-uk-and-how-are-recent-updates-relevant-to-me/]

This blog article has been prepared by Dr Kirsty Wydenbach with input from members of FPM's Policy and Communications Group and Clinical Trials and Regulatory Expert Group

The article presents the views of the authors and not necessarily those of the Faculty of Pharmaceutical Medicine.

Introduction

As the Faculty of Pharmaceutical Medicine (FPM) noted in a blog published in April 2023, industry-sponsored clinical trials are in decline in the UK. Since 2017, we have witnessed a 41% fall in the number of trials initiated and a 44% drop in the number of UK participants recruited[1]. Action is required to reverse this trend and ensure patient access to research and promising innovations improves dramatically, providing widespread benefit to the whole healthcare ecosystem, including the NHS, academia, industry, and most importantly, patients.

In Oct 2022, the Royal College of Physicians (RCP) and the National Institute for Health and Care Research (NIHR) published a joint position statement on ‘Making research everybody’s business.’ This includes ‘making it the business’ of pharmaceutical physicians. Through the expertise of our membership, many of whom are working at the front line of clinical research in the UK, FPM is in a unique position to develop and enable Government recommendations for UK research: but first, we all need to know what those recommendations are.

In this blog, FPM provides an overview of the recent announcements by the UK Government, regulatory bodies and the more expansive research space to enable FPM members and others in the pharmaceutical industry to answer the critical question “What does it all mean, and how is it relevant to me?”. The intent is to provide a brief educational grounding so the FPM and its members can help develop recommendations for enhancing the partnership with industry and consistent objectives and positions to increase the policy support the FPM can provide for interventional clinical trials in the UK.

[1] rescuing-patient-access-to-industry-clinical-trials-in-the-uk.pdf (abpi.org.uk)

Since 2017, we have witnessed a 41% fall in the number of trials initiated and a 44% drop in the number of UK participants recruited.

Recent announcements for UK researchers

The UK science sector is ‘the envy of the world’ according to the opening statement in the recent report from Lord O’Shaughnessy. Still, unfortunately, this position has been eroded by progress by its global competitors. Since then, the UK Government has published information on future plans, committed to additional funding, and pledged support for the MHRA and other research bodies via recent announcements, aiming to reverse the decline of UK research.

The list below briefly summarises each announcement, starting with the founding vision from 2021.

The Future of UK Clinical Research Delivery (A Ten-Year Vision) sets out the vision for a more patient-centred, pro-innovation and digitally-enabled clinical research environment, which builds on the successes and the lessons learned in response to COVID-19 and harnesses the UK’s potential to capitalise on cutting-edge innovations across all treatments and technologies, all phases of research and all conditions.

The vision puts clinical research delivery front and centre of Government plans to build back better to tackle future healthcare challenges, and patients across the UK and worldwide benefit from better health outcomes.

The five key themes underpinning the vision are:

clinical research embedded in the NHS
patient-centred research
streamlined, efficient and innovative research
research enabled by data and digital tools
a sustainable and supported research workforce

Spring budget 2023: At Autumn Statement 2022, the government asked Sir Patrick Vallance to lead the Pro-innovation Regulation of Technologies Review. The government is taking forward Sir Patrick’s recommendations on regulating emerging digital technologies, published alongside the Spring Budget. Based on Sir Patrick’s interim findings on life sciences, the government is providing extra funding for the Medicines and Healthcare Products Regulatory Agency (MHRA) to help it maximise the use of its Brexit freedoms and accelerate patient access to treatments.

Commercial clinical trials in the UK: the Lord O’Shaughnessy review – final report: In February 2023, the government commissioned an independent review to offer recommendations on resolving key challenges in conducting commercial clinical trials in the UK and transforming the UK’s commercial clinical trial environment. The review outlines 27 recommendations, including priority actions to progress in 2023 and longer-term ambitions for UK commercial clinical trials.

The review was conducted by Lord James O’Shaughnessy, Senior Partner at consultancy firm Newmarket Strategy, Board Member of Health Data Research UK (HDR UK) and former Health Minister, who was appointed as review Chair. Lord O’Shaughnessy consulted closely with industry and stakeholders across the UK clinical trials sector, including FPM during the review.

Government response to the Lord O’Shaughnessy review into commercial clinical trials in the UK: In principle, the government welcomed all recommendations from Lord O’Shaughnessy’s review and will consider the delivery of all recommendations. The government made five headline commitments as an immediate first step, backed by up to £121 million. These headline commitments will improve the speed of commercial clinical trials in the UK. In addition, they will take forward the foundational actions that will be adopted as part of the government and the health system’s ongoing work to support commercial clinical trials. Finally, the government will provide an implementation update in the autumn, outlining progress against these commitments and responding in full to the remaining review recommendations.

Pro-innovation Regulation of Technologies Review: Life Sciences and the government response: Professor Dame Angela McLean, the Government Chief Scientific Adviser, with input from experts Sir John Bell and Camilla Fleetcroft, has conducted a review of how pro-innovation regulation can support life sciences and has put forward recommendations to government. This report follows the publication of reports on digital technologies and green industries as part of the Pro-Innovation Regulation of Technologies Review. As in those reports, this review focuses on the specific regulatory opportunities identified for action within the next 12-18 months. It follows extensive engagement across government, regulators, industry and academic experts to identify actions that could realistically resolve problems in these short time scales.

Chancellor reveals life sciences growth package to fire up economy: The multi-faceted ‘Life Sci for Growth’ package brings together ten different policies, including £121 million to improve commercial clinical trials to bring new medicines to patients faster (see above), up to £48 million of new money for scientific innovation to prepare for any future health emergencies, £154 million to increase the capacity of the UK’s biological data bank further aiding scientific discoveries that help human health, and up to £250 million to incentivise pension schemes to invest in our most promising science and tech firms.

The Chancellor’s £650 million package also includes plans to relaunch the Academic Health Science Network as Health Innovation Network to boost innovation by bringing together the NHS, local communities, charities, academia and industry to share best practices.

Response to consultation on UK clinical trial legislation: The MHRA and the Department of Health in Northern Ireland, working closely with the HRA, consulted on a set of proposals to update, improve and strengthen the UK legislation that underpins the regulation of clinical trials. Having analysed over 2000 responses received, they will now take forward legislation to reform the UK clinical trials regulatory framework. These will include guidance on diversity in trial populations and a more flexible risk-appropriate regulatory approach while streamlining the application process with combined reviews to reduce duplication.

MHRA announces new recognition routes to facilitate safe access to new medicines with seven international partners: MHRA announced new regulatory recognition routes for medicines that will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States. These recognition routes, facilitated by existing international partnerships such as those developed through the Access Consortium and Project Orbis, mark the start of a new global recognition framework for medicines that will be in place by the first quarter of 2024.

New regulatory pathway set to support safe patient access to innovative medical technologies: Plans are advancing for a new regulatory pathway that facilitates the development of innovative technologies by providing innovators and manufacturers with a multi-partner support service, including targeted scientific advice that brings new products to patients sooner. Set for launch later in 2023, the IDAP will be run by the MHRA, NICE, and other partners, including the devolved administrations. This new programme aims to bring innovative technologies and solutions to the forefront of the National Health Service (NHS) through a new, integrated support service for developers that will include enhanced opportunities for early engagement.

Innovation Ecosystem review programme: This work will cover both NHS support to enable and embed clinical research and how the NHS can most effectively drive the adoption and spread of proven and cost-effective innovations to all patients who would benefit from them. The innovation ecosystem is incredibly complex, with multiple initiatives, organisations and a wide range of localised networks and cultures, and resolving this cannot solely be achieved by NHS action. The review will therefore prioritise broad engagement and gaining consensus and buy-in from key partners. There are five key priorities:

Priority 1: Embedding Research: Increase the speed, scale and diversity of research in the NHS
Priority 2: Demand signalling and horizon scanning
Priority 3: Uptake of proven innovation
Priority 4: Building innovation capacity
Priority 5: Innovator support

However, the UK cannot act in isolation despite Brexit resulting in separation from some EU processes, potentially enabling more flexibility. As outlined below, other global announcements impacting the UK research environment have also happened this year.

Consultation on the International Council for Harmonisation (ICH) E6 (R3) Good Clinical Practice (GCP) Guidelines: The ICH Expert Working Group (EWG) for ICH E6(R3) has been updating ICH E6(R2) GCP guidelines. The MHRA represents the Pharmaceutical Inspection Co-operation Scheme (PIC/s) in the EWG. Compliance with the ICH E6(R3) GCP Principles, but not the entirety of the guideline, will become a legal requirement in the UK. MHRA is consulting with UK stakeholders to compile and coordinate their comments to the EWG. A summary blog is available. The European Medicines Agency (EMA) are also holding a public workshop.

As of 31 January 2023, all initial clinical trial applications in the European Union (EU)/European Economic Area (EEA) must be submitted through the Clinical Trials Information System. European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. It aims to ensure that the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants.

European Health Union: Commission proposes pharmaceuticals reform for more accessible, affordable and innovative medicines: The European Commission is proposing to revise the EU’s pharmaceutical legislation – the most significant reform in over 20 years – to make it more agile, flexible, and adapted to the needs of citizens and businesses across the EU. The objectives of the revision are to make medicines more available, accessible and affordable. It aims to support innovation and boost the competitiveness and attractiveness of the EU pharmaceutical industry while promoting higher environmental standards. In addition to this reform, the Commission proposes a Council Recommendation to step up the fight against antimicrobial resistance (AMR).

What does this mean for me?

It is not always easy to see how reports and changes such as those outlined above can impact each area in the pharmaceutical industry, and it can be even harder to see if there may be changes in your area of expertise, particularly if that sub-speciality has seemingly not been mentioned.

Those in regulatory affairs or a more strategic clinical research and development role will need to remain updated on the UK and EU legislation changes since they will impact legal requirements, underlying processes, and what guidelines can be predicted in the future. Many of the announcements, for example, the global regulatory partnerships, will impact how regulatory and clinical development teams align, most certainly altering how medical affairs work with those earlier in the development lifecycle. There will be even more opportunities to talk to regulators to streamline programmes in the UK and globally. Changes will not happen overnight, but keeping current as Government plans progress is critical. Many of the recommendations aim to further break down barriers between regulators, what they all do on a day-to-day basis, and how that dovetails into industry needs and requirements. How the industry responds to these changes is still an open question, as there may be commercial concerns. Nevertheless, focusing on enabling access to patients with evidence-based value pricing will support the delivery of research and its objectives. Pharmaceutical physicians are responsible for keeping these objectives at the forefront in positively influencing their corporate sponsors to engage collaboratively with these changes. The MHRA have previously stated that ‘Regulators don’t bite’, so use these upcoming possibilities to get their opinion.

For example, frontline researchers and clinical investigators can expect local considerations, such as contracting and approvals, to improve. There is also the possibility of working closely with colleagues outside the industry at the heart of NHS delivery and whom the Government are keen to include more in research. Lord O’Shaughnessy’s recommendations note the current failure to make the most of the NHS, including primary care, and expanding the use of research networks is also something we can expect to see, and all be a part of.

As the recommendations are taken forward into new processes and future ways of working, this is also an ideal opportunity to review and question your own working culture and see what can be changed. It is not just about embracing innovation (a key priority of progressing UK research) but streamlining and ensuring you do not get left behind as an individual and that the company you work for positively adapt to working with these reforms rather than failing to engage and maximise their potential. With revalidation and appraisals being an annual part of being a pharmaceutical physician, it is also imperative that everyone stays updated and looks ahead to try and embed some aspect of the recommendations into their objectives. A good example is maintaining GCP training and ensuring the inclusion of appropriate updates for the changes that may come from ICH E6(R3).

Summary

The UK research landscape continues to evolve, bringing opportunities to ensure legislation and processes optimise time and reduce complexity. The importance of improving UK access to industry-sponsored interventional clinical trials and providing patient benefits cannot be underestimated. The FPM and its members are a core part of the future direction, and we will be looking to how FPM can best use its insights and expertise to influence and shape the UK Life Sciences Vision.