Policy paper

The Future of Clinical Research Delivery: 2022 to 2025 implementation plan

Published 30 June 2022

This was published under the 2019 to 2022 Johnson Conservative government

Ministerial foreword

In 2021 we, the UK and devolved governments, set out our vision for the future of clinical research delivery. Saving and Improving Lives: The Future of UK Clinical Research Delivery lays out our ambition to create a world-leading UK clinical research environment that is more efficient, more effective and more resilient, with research delivery embedded across the NHS. We also set out our plans for 2021 to 2022, as the first steps in delivering on the vision.

A digitally enabled, pro-innovation and people-centred clinical research environment is key to realising our ambitions to make the UK a world-leading hub for life sciences that delivers improved health outcomes for our citizens and attracts investment from all over the world. We will harness the explosion in innovative technologies to benefit patient outcomes and make a tangible difference to people’s lives across the UK. Clinical research is crucial to these efforts, as the lynchpin to driving improvements in healthcare.

As we emerge from the shadow of the pandemic and look to the future, we will work together to ensure that the UK is seen to be one of the best places in the world to deliver cutting-edge clinical research. We are working hard both to recover research delivery in the NHS and to use this moment as a catalyst for transformation, building increased resilience and embedding innovative practice as we go. The cross-sector partnerships built through the UK Clinical Research Recovery, Resilience and Growth (RRG) programme provide the strong foundations we need to succeed, drawing on expertise and support from industry, academia, charities, patients and the public, regulators, funders and the NHS.

Our vision was clear on the importance of unleashing the true potential of clinical research across the UK, addressing long-standing health inequalities and improving the lives of us all. We, the UK and devolved governments, are excited to set out the next stages as we look to turn our vision into a reality and build a clinical research system of the future.

Lord Kamall of Edmonton in the London Borough of Enfield
Parliamentary Under Secretary of State for Technology, Innovation and Life Sciences
Department of Health and Social Care

Robin Swann
Minister for Health
Northern Ireland Executive

Eluned Morgan
Minister for Health and Social Services
Welsh Government

Humza Yousaf
Cabinet Secretary for Health and Social Care
Scottish Government

Executive summary

In March 2021, we published our bold and ambitious 10 year vision: Saving and Improving Lives: The Future of UK Clinical Research Delivery. This was followed in June 2021 by The Future of UK Clinical Research Delivery: 2021 to 2022 implementation plan setting out the steps we would take to progress the vision in 2021 to 2022.

This phase 2 plan summarises the progress that we have made so far and the actions that we will take over the next 3 years, from 2022 to 2025, ensuring we make the progress necessary to achieve our vision in full by 2031.

This plan has been developed by the cross-sector UK Clinical Research RRG Programme in consultation with stakeholders from across the clinical research ecosystem. Our plan is centred around the 5 overarching themes identified in the vision:

1. a sustainable and supported research workforce to ensure that healthcare staff of all backgrounds and roles are given the right support to deliver clinical research as an essential part of care
2. clinical research embedded in the NHS so that research is increasingly seen as an essential part of healthcare to generate evidence about effective diagnosis, treatment and prevention
3. people-centred research to make it easier for patients, service users and members of the public across the UK to access research and be involved in the design of research, and to have the opportunity to participate
4. streamlined, efficient and innovative research so that the UK is seen as one of the best places in the world to conduct cutting-edge clinical research, driving innovation in healthcare
5. research enabled by data and digital tools to ensure the best use of resources, leveraging the strength of UK health data assets to allow for more high-quality research to be delivered

We have made significant progress over the past year – a new combined review process has led to halving of approval times for new Clinical Trials of Investigational Medicinal Products (CTIMPs) since January 2022 compared to previous separate applications, streamlining the route through the regulatory journey for researchers, the world-leading £200 million data for research and development programme has been announced to invest in health data infrastructure in England with devolved administrations aligning and strengthening their infrastructure; and a new UK-wide professional accreditation scheme for Clinical Research Practitioners (CRP) has been launched to help double the size of this important workforce in the future.

However, the recovery of research delivery following the pandemic remains challenging. The Department for Health and Social Care (DHSC) and NHS England are taking firm action to address this, with the support of the devolved administrations, through the ‘Research Reset’ programme. We are committed not only to returning to pre-pandemic levels of performance, but to using this as an opportunity to reform and catalyse the transformation needed to create the flourishing, responsive and resilient system set out in our vision.

The phase 2 plan is aligned with funding confirmed through the government spending review for April 2022 to March 2025 and includes up to £150 million of additional funding from the National Institute for Health and Care Research (NIHR) and £25 million additional funding from RRG partners across the UK, complementing up to £200 million in England for the data for research and development programme announced in March 2022 and demonstrating the government’s ongoing commitment to delivering on the UK’s potential as a global life sciences superpower. This funding will enable RRG partners to:

• recover the UK’s capacity to deliver research through DHSC and NHS England’s Research Reset programme, and aligned work in the devolved administrations, aiming for 80% of all open studies on the NIHR Clinical Research Network (CRN) portfolio to be delivering to time and target by June 2023
• ensure we can recognise and support our expert workforce, and develop robust workforce plans, providing the basis for strategic investment in capacity development to support achievement of our vision in full
• broaden responsibility and accountability for research across the NHS, and improve measurement, visibility and recognition of those supporting the delivery of clinical research studies
• achieve a sector-wide, sustained shift in how studies are designed and delivered so that inclusive, practicable and accessible research is delivered with and for the people with the greatest need and in ways that enable us to tackle the greatest challenges facing the NHS
• streamline processes, strengthen our regulatory environment and ensure faster approval, set-up and delivery of studies with more predictability and less variation, as well as make it easier to understand and access the UK’s clinical research offer, thereby utilising the unique opportunity to develop a more flexible and improved regulatory model for clinical research outside the EU and improving our attractiveness as a leading destination to conduct cutting edge and global multi-centre clinical studies
• invest in the infrastructure and tools needed to implement people-centred, innovative data and digitally-enabled methods and increase partnership working across the health data ecosystem to ensure people across the whole of the UK can benefit from these approaches

The RRG programme will oversee the delivery of this plan, continuing to work in partnership with stakeholders across the sector and regularly revisiting the original vision to consider any further actions that will be needed to deliver it in full. In doing so, we will ensure that the NHS is able to tackle the healthcare challenges of the future and people across the UK and around the world will benefit from better health outcomes.

Further information about the RRG programme, including our delivery partners and governance, are available on the dedicated Recovery Resilience and Growth website. Detailed summaries of our progress to date and our future plans will be published on the site on an ongoing basis, providing a central point of information and updates about the programme and our progress towards achievement of the vision. You can also sign up to receive regular email updates on our progress.

UK-wide approach

Health policy is a devolved responsibility, where each of the UK administrations has distinct ownership over implementation. However, we are committed to delivering on a vision with a UK-wide reach and in pursuit of a common goal: to create a seamless and interoperable service across the UK to support clinical research delivery, shaping the future of healthcare and improving people’s lives.

We are therefore further strengthening a joined-up system, where sponsors of both commercial and non-commercial research can easily deliver studies across the UK and people can more easily participate. To ensure compatible and consistent ways of working across England, Scotland, Wales and Northern Ireland many commitments in this plan are focused on UK-wide implementation. Organisations such as MHRA (Medicines and Healthcare products Regulatory Agency) and systems such as IRAS (Integrated Research Application System) have a UK-wide reach and their actions will have impacts across the country. In some instances, actions are being led by a specific organisation on behalf of the UK, while others will be delivered through UK partnerships – recognising the different legislative and delivery contexts across the UK government and devolved administrations.

Scope

The needs of UK citizens and our health research system are broad and diverse. We are committed to maintaining a rich and balanced portfolio of studies in rare and common diseases, ranging from complex, intensive studies in small, highly targeted populations to pragmatic population health research in large cohorts, using a range of methodologies and methods as appropriate to the research questions.

Our vision focuses specifically on the future of UK clinical research delivery. Other types of research, including social care and public health research, are vitally important to provide the evidence necessary to support policy making and service delivery in these areas. Many partners involved in the RRG programme support this broader programme of research activity and other work programmes are underway to enable their development. We expect that many of the improvements we make in the clinical research environment will have benefits for other kinds of research and will work across our organisations and with wider groups of stakeholders to ensure the lessons are shared.

Research reset

As we recover from the pandemic, clinical research delivery is facing unprecedented challenges and there is an urgent need to reset the UK’s research portfolio so we can build for a stronger future.

The number of studies in the NHS is now higher than ever before. This is accounted for by the additional COVID-19 studies, other research that has remained on the portfolio from before the pandemic and has been paused or delayed, together with new studies being funded and coming into the system. In addition, the number of studies in set up is now much higher than pre-pandemic, further increasing the workload for NHS R&D offices and research delivery teams. This is taking place in the context of the recovery of wider NHS services and resourcing the high number of studies is challenging. Throughout this, the resilience of the workforce has been remarkable.

Recovery of the UK’s capacity to deliver clinical research is essential if we are to deliver the ambitions set out in this phase 2 plan. Indeed, many of the challenges the vision seeks to address have been exacerbated by the pandemic, so Research Reset and reform go hand in hand.

Since summer 2020, all delivery partners across the sector have been working to restore the diverse and balanced portfolio of studies which were impacted due to the COVID-19 pandemic. While this has had some positive impact, it has not resulted in the restoration of activity across all studies that were underway before the pandemic. We are taking further action through the Research Reset programme to build back a thriving, sustainable and diverse research and development portfolio within the NHS.

Our objective in implementing Research Reset is to give as many studies as possible the chance of completing and yielding results, generating the evidence needed to improve care and sustain our health system. However, this will require closure of studies that are not viable in the current context to free delivery resources in the system for those studies that can deliver. Lessons must also be learned to reform and increase the resilience of our research system. As part of this we have asked funders and research sponsors to review their active studies to assess the viability of delivering these within the capacity available.

Our aim is for 80% of all open studies on the NIHR CRN portfolio to be delivering to time and target by June 2023. We will take an agile approach to the Research Reset programme, continuously assessing whether further action is required with the input of stakeholders across the sector including patients and the public.

The devolved governments support this approach and we are working together across the UK to ensure synergistic arrangements are in place to promote the smooth delivery of cross-border studies. Each devolved administration will also review possible new eligibility criteria for national delivery support to ensure deliverability within available resources is feasible.

A sustainable and supported research workforce

The UK clinical research workforce has been fundamental to our collective success to date and will be critical to the achievement of our vision in the future. Healthcare and research staff of all backgrounds must be offered rewarding, challenging and exciting careers within clinical research, so that the most talented people can be brought into clinical research, including research delivery and R&D management, as a life-long career. This will help to bolster the capacity of the clinical research system and support a motivated and sustainable workforce. Collectively, we can realise the potential of UK clinical research to improve outcomes for people across the country, sustain our NHS and improve the economy.

Progress over the past 12 months:

• in England, to support the drive to recover the portfolio, DHSC provided over £30 million of additional funding via the NIHR Clinical Research Network (CRN) in the 2021 to 2022 financial year to increase research delivery capacity, especially in community settings and with a key focus on achieving flexibility and agility in the workforce. The Welsh Government provided £1.7 million to support additional capacity in order to achieve the recovery of non-COVID-19 research, including development of research capacity outside of hospital settings. £3 million of funding from the Department of Health in Northern Ireland has been provided to support the work of a Taskforce established to address clinical research recovery in Northern Ireland
• the NIHR, working with the devolved administrations, launched a UK census for nurses and midwives working in clinical research in order to understand the true size of this workforce. Data was also sought on location, speciality and banding or grade. It was able to identify that there are at least 7,469 research nurses and midwives across the UK and Ireland working at every level and within all areas of healthcare. This census demonstrates the breadth and depth of nurse and midwife involvement in research across the healthcare sector
• in June 2021, NIHR on behalf of the UK launched a new UK-wide professional accreditation scheme for Clinical Research Practitioners (CRP) as part of efforts to double the number of this important workforce over the next few years. Over 1,000 members have already signed up to the CRP directory
• NIHR also launched the UK wide Associate Principal Investigator Scheme, which aims to make research a routine part of clinical training so doctors, nurses and allied health professions can become the principle investigators of the future. Over 1,000 health and care professionals had registered for the scheme by April 2022
• in February 2022, Wales published a vision for research career pathways that outlines recommendations to improve support and encourage more health and social care professionals to embark on research careers

Phase 2 commitments

To continue this progress and build towards a sustainable and supported research workforce, we will ensure we can retain and recognise our expert staff and develop robust workforce plans to provide the basis for strategic investment in capacity development:

• the RRG Programme will lead the development of a cross-sector research workforce plan to support implementation of our vision in full. Developed over 2022 to 2023, this plan will guide additional investment in our workforce from 2024
• RRG partners will ensure workforce plans developed by key healthcare organisations include research requirements, particularly noting the knowledge and skills needed across the wider workforce to deliver research as an essential part of high-quality care. This will include the NHS People Plan, coordinating with Health Education England and DHSC, and equivalent plans in the devolved administrations
• NHS England, working with its partners is developing a comprehensive, long-term NHS workforce plan. This will include consideration of research requirements to support the delivery of high-quality care
• Health Education and Improvement Wales, working closely with Welsh Government and the NHS, will develop plans to support and facilitate the nursing, midwifery, allied healthcare professionals and health sciences professions in embracing research as part of their roles and career pathways. Through the development of competency and skills frameworks, Health and Care Research Wales is working to support the inclusion of research delivery roles
• NIHR will provide investment to support NHS R&D transformation, increase research capacity including nurses, midwives and allied healthcare professionals, and provide more opportunities for rewarding careers in research
• the RRG partners will expand the package of training programmes for the research workforce including through the RCP-NIHR Credentialing Scheme, the NIHR Associate PI scheme, the NIHR Nurse and Midwife Leaders Programme, an NHS England programme for executive nurses in Trusts and Integrated Care Systems (ICSs), and a research matron’s toolkit
• NIHR and the devolved administrations will invest in learning and support for researchers, so that they are equipped with the expertise and cultural competency to design and deliver people-centred studies to meet the needs of patients, service users and the public, including those from underserved communities and groups not traditionally served by research
• in support for NHS R&D transformation, Wales will invest in a new Health and Care Research Wales Faculty, which will include increased investment in the NHS Research Time scheme to help develop the next generation of principal and chief investigators in the NHS alongside enhanced mentorship schemes

Clinical research delivery embedded in the NHS

Our aim is to create a step change in the delivery of clinical research in the NHS, so that research is increasingly seen as an essential part of healthcare. Making research an intrinsic part of clinical care means that patients and service users can expect to have access to the most cutting-edge treatments and technologies. We want the NHS to actively participate in generating evidence about effective diagnosis, prevention and treatment through research. By acknowledging the important role of the whole of the healthcare workforce in clinical research delivery, we can ensure everyone is empowered to get involved in research and further boost overall capacity for research in the NHS and wider health system. Measuring clinical research will also support NHS leaders to drive behaviour change and incentivise more engagement in research activity. Finally, ensuring clinical research is embedded within the NHS will be essential in giving the UK the capacity to grow in an increasingly competitive global market.

Progress in Phase 1:

• the UK Research and Development (UKRD) and NHS R&D Forum, with NIHR, developed the ‘Best Patient Care, Clinical Research and You’ online guide that aims to help busy non-research staff become more aware of the impact of research in their trust

• the General Medical Council (GMC) published its position statement Normalising Research - Promoting Research for all Doctors

• the Allied Health Professions’ Research and Innovation Strategy was published, addressing the key areas which impact research and innovation across all health professions in England

• the NHS Chief Nursing Officer (CNO) for England published the strategic plan for research for nurses. The plan aims to create a people-centred research environment that empowers nurses to lead, participate in and deliver clinical research that is fully embedded in practice and professional decision making

• together with existing strategies in the devolved administrations, we are continuing the development of UK-wide support for the key professional groups

Phase 2 commitments

In order to more deeply embed clinical research in the NHS, we will take action to broaden responsibility and accountability for research across the NHS, and improve measurement, visibility and recognition of those supporting the delivery of clinical research studies. The role of healthcare leaders and professionals will be vital in this:

• NHS England and the devolved administrations will each develop clear and tangible plans to work towards embedding responsibility and accountability for research in healthcare delivery

• NHS England and the devolved administrations will use existing legal duties and planning frameworks to promote and facilitate research. Each administration will develop assurance frameworks and use existing channels such as annual reports and joint forward plans to help cement the importance of research as a core duty. In England this will include the implementation of the Health and Care Act. Integrated Care Boards (ICBs), NHS England and the Secretary of State for Health and Social Care will all have enhanced duties to report on how they are promoting and facilitating research. NHS England will also lead development of a research framework for ICBs to help them understand and fulfil the minimum expectations around research that the Health and Care Act sets. This will herald a significant shift in how research is considered within the NHS and drive a greater responsibility for more research activity across all sites. In Wales, we will explore opportunities provided through the development of the NHS Executive in Wales to strengthen the national oversight of NHS research
• we will work across the UK administrations to introduce new metrics and measures to increase the visibility and recognition for undertaking and supporting clinical research across NHS organisations
• NIHR, working in partnership with NHS England and the devolved governments, like the Scottish Health Research Register (SHARE), will continue to enhance the UK Be Part of Research platform through collaboration with other existing registries. National digital channels (for example the NHS App or NHS website) will feed into the Be Part of Research platform

The RRG programme will ensure strategic co-ordination of this work across the UK clinical research ecosystem, supporting progress and ensuring alignment of initiatives, as well as identifying key areas where we can go further in the next 3 years.

People-centred research 

The vision set out our ambition for more people-centred research, designed to make it easier for patients, service users and members of the public to access research of relevance to them and be involved in its design. To achieve this, delivery of research in community, primary care and virtual settings needs to increase, with delivery designed around the needs of the people participating in it. Alongside this, we will ensure we maintain our world-leading specialist research infrastructure, which provides opportunities for people to access early-phase studies, complex therapies and devices.

Progress in Phase 1:

• delivering studies such as PANORAMIC and IBS-RELIEVE has demonstrated the UK’s growing ability to harness technology and conduct studies virtually and in the community
• HRA and MHRA, in collaboration with NHS Research Scotland, Health and Social Care Northern Ireland (the equivalent to the NHS in Northern Ireland), and Health and Social Care Research Wales, have published UK-wide guidance on the set up of interventional research to enable research to be delivered across organisational boundaries and to help take research to where people might find it easier to take part, for example using hub and spoke models
• the NIHR led UK Working Group on Remote Trial Delivery published a report in June, which discussed the challenges and opportunities in remote trial delivery and provided guidance for researchers
• the NIHR Race Equality Framework was piloted by industry. This self-assessment tool helps organisations to improve racial equality in health and care research
• partners across the UK are working together to ensure patient and public involvement in research in a variety of ways including through regulation, ethics, payment for public contributors and development of new public engagement strategies. This includes the publication of a shared commitment to public involvement in research to ensure involvement is built into study design, delivery, and dissemination
• in Northern Ireland the Clinical Research Recovery Resilience and Growth Taskforce implementation plan includes a patient and public engagement and involvement sub-group, which is focused on the development of patient and public centred priorities, and an innovation sub-group planning approaches to innovative and people-centred trial design
• in Wales, the ‘Discover your Role’ programme is underway, with a co-created action plan to ensure that people are at the heart of new developments in research
• the NHS Research Scotland patient and public involvement workshop series completed and reported in September 2021. Findings from the workshops and the Scottish Patient Public Involvement Survey are informing work to support greater visibility and connectivity, increased diversity and representation, and a review of the current mechanisms for pre-award funding
• RRG partners have partnered with the International Standard Randomised Controlled Trial Number (ISRCTN) registry to make it easy for researchers to fulfil their transparency responsibilities. Trial registration is the first step to ensuring research transparency from the outset, and from 2022 the HRA began automatic registration of clinical research with ISRCTN, taking the burden away from research sponsors and researchers

Phase 2 commitments

Our aim will be to achieve a sector-wide, sustained shift in how studies are designed and delivered so that inclusive, practicable and accessible research is delivered with and for the people with the greatest need and in ways that enable us to tackle the greatest challenges facing the NHS. The UK’s ability to deliver diverse trials and studies will also give us a competitive advantage on the global stage, attracting researchers from around the world to base their studies here:

• the HRA is leading a cross-sector project, co-produced with public contributors, to collect evidence about how high quality, people-centred clinical research is done well: finding out what matters most, what ‘good’ looks like and what might be making it difficult. It will make recommendations to help improve the way clinical research happens in the UK and disseminate information about actions and resources developed by partners
• NIHR will invest in the development of skills and tools for innovative trial delivery, increasing the confidence and ability of our researchers to design and deliver studies in people-centred ways
• NHS England will launch a toolkit that could be used by researchers across the UK to help them engage more effectively with selected underserved communities. NIHR will also promote increased use of the resources developed by the NIHR INCLUDE project project which enable researchers to increase inclusion of underserved communities in their research
• NIHR and NHS Digital will develop mechanisms to monitor the diversity of people participating in NIHR Clinical Research Network portfolio studies in England in order that we can understand where improvement is needed and what action will be most effective.
• in England, the NHS Accelerated Access Collaborative will invest in demand signalling (the process of identifying, prioritising and articulating the most important research questions) and horizon scanning (the process of identifying and better understanding emerging transformational technologies of potential benefit to the NHS and our communities) to improve identification of the most needed treatments and technologies and rapidly bring these into clinical use
• in Scotland, SHIP is leading the new Scottish Health and Industry Partnership Demand Signalling Plan. This new framework will support identification and decision making around key strategic challenges and operational pressures to accelerate NHS Scotland Re-mobilisation, Recovery and Re-design, aligning with delivery of the NHS Recovery Plan 2021 to 2026, and the Life Science Vision healthcare missions
• medical research charities play an important role in supporting people-centred research, utilising their contacts with patients and communities, and prioritising their needs when setting a research agenda. The Association of Medical Research Charities (AMRC) will be working with NIHR and NHS England to formalise this work – and will share findings once developed across the UK

The RRG programme will ensure strategic co-ordination of this work across the UK clinical research ecosystem, supporting progress and ensuring alignment of initiatives, as well as identifying key areas where we can go further within the next 3 years.

Work is also underway to improve access to research through digitised recruitment as detailed in the section on research delivery enabled by data and digital tools.

Streamlined, efficient and innovative research 

Facilitating research to happen quickly and predictably will not only bolster our economy and status as a life sciences superpower, but will also drive innovation, which translates into improved care. We have the opportunity to develop a more flexible and improved regulatory model for clinical research outside the EU in the best interests of patients and the public, and since the publication of the vision we have been building towards our aims of supporting a more streamlined, efficient, and effective clinical research environment.

Progress in phase 1:

• in a new approach to licensing and regulation implemented by the MHRA, NICE, the All Wales Therapeutics and Toxicology Centre (AWTTC) and the Scottish Medicines Consortium (SMC), over 100 innovation passports have been issued through the Innovative Licensing and Access Pathway (ILAP), to robustly and safely support the path to market of the most innovative, transformative treatments
• the combined review from the MHRA and the UK Research Ethics Service, in collaboration with the HRA facilitates speedier set up for clinical research trials by requiring applicants to only make a single application for both Clinical Trial Authorisation (CTA) and Research Ethics Committee (REC) approval. Since January 2022, all new Clinical Trials of Investigational Medicinal Products (CTIMPS) in the UK have been benefiting from the combined review, halving the approval time compared with separate applications over the period 2018 to 2021
• the range of model UK contracts agreed with industry and the NHS has been expanded including the first UK-wide model Clinical Investigations Agreement (UK mCIA) for research in medical devices, and the first Model Confidentiality Disclosure Agreement (mCDA) for use by companies with potential NHS sites has also been launched
• the MHRA ran a public consultation on proposals for legislative changes for clinical research. The proposals aim to promote patient and public involvement in clinical research, increase the diversity of participants, streamline clinical research approvals, enable innovation, and enhance clinical research transparency. The consultation sought the views of the wider public, clinical research participants, researchers, developers, manufacturers, sponsors, investigators, and healthcare professionals to help shape this important future legislation and over 2,000 responses were received
• NHS England published refreshed guidance on Excess Treatment Costs (ETCs), expanding the framework to include studies where Clinical Commissioning Groups are the commissioner for the service where the study takes place and setting out the provider types which can utilise the national payment system in England. From April 2022 the provider thresholds for ETCs has been reduced, meaning that the number of providers who receive ETCs will increase

Phase 2 commitments

In our next phase of work, we will streamline processes, further strengthen our regulatory environment and ensure faster approval, set-up and delivery of studies with more predictability and less variation. Significant emphasis will be placed on reducing unwarranted variation in ways of working across sites and other research infrastructure, so that conducting clinical research in the UK is high quality, predictable and reliable. This will be particularly important for commercial contract research as speed and predictability is key to the UK’s competitiveness and our ability to attract global multi-centre research studies into the NHS.

The UK is globally recognised for its scientific expertise and dedicated research infrastructure. However, the devolved healthcare systems and competition between organisations has created a complex landscape which is difficult to navigate and creates barriers for researchers and companies. We will work across the UK clinical research system to ensure it is easier to understand and is attractive as a leading destination to conduct cutting edge clinical studies.

To improve research approvals and strengthen our regulatory frameworks:

• a single UK approval service will replace HRA and HCRW Approval and equivalent process in Northern Ireland and Scotland, and site permission and confirmation processes across the UK
• MHRA will work with HRA in continuing the development of IRAS to streamline health technology and medicines research, and HRA will explore whether it is viable to embed a fast-track ethics review as part of combined review
• HRA will lead UK-wide work to further expand the suite of model agreements, including decentralised and other innovative delivery models as well as particular fields of innovative products such as Advanced Therapy Medicinal Products
• following public consultation on proposals for legislative changes for clinical research, the MHRA is now carefully analysing the responses received, preparing a Government response and developing secondary legislation to improve and strengthen our clinical research legislation
• MHRA will support risk-proportionate trial conduct and monitoring, including through Good Clinical Practice (GCP) guidance and pragmatic investigator guidance, and will work with HRA to develop guidance on use of in vitro diagnostics (IVDs) in clinical research
• MHRA and HRA will also establish a comprehensive stakeholder reference group to assist with guidance generation on new legislation and ensure there is a common understanding of regulatory requirements that will enhance the UK’s international attractiveness as a place to conduct multinational trials

To improve study set-up:

• learning lessons from delivering COVID-19 research, we will enhance our early feedback service offer via the NIHR CRN to support study design that is optimised for delivery and explore how we can further match research delivery demand to capacity across the UK
• we will implement the UK-wide National Contract Value Review (NCVR), with the aim of expediting the costing elements of the contracting process across NHS Trusts to ensure costing does not delay study set-up. From 1 April 2022, the NCVR will begin to replace the current time-consuming process whereby each NHS organisation negotiates with each commercial sponsor for every study in order to agree bespoke contract value. The programme will be monitored throughout implementation to ensure lessons can be learnt and the process improved to ensure it achieves its aims. The existing single cost and contract review model in Scotland and across the NIHR Patient Recruitment Centres in England will integrate with NCVR as it develops, supporting more effective UK alignment and efficiency
• the Experimental Cancer Medicine Centre (ECMC) Network, with support from MHRA and HRA, will complete their pilot to set up Phase I oncology trials within 80 days of IRAS submission. Learning from this programme will be shared to enable improved set-up performance in other specialities
• RRG programme partners will identify and establish mechanisms to achieve efficient costing and contracting across other parts of the health system, supporting and enabling an increase in decentralised study designs and research taking place in primary care and community settings.
• DHSC and NHS England will lead a review of their current Excess Treatment Costs (ETC) process in England to review experiences of the policy and t explore how best we can support non-commercial research in the NHS

To make the UK offer easier to navigate:

• the RRG partners will develop a strategic plan, with input from partners and associated organisations across the UK’s research infrastructure, on how we will unify, streamline and promote our services and support. We will work with others across the UK clinical research system to ensure that all companies, researchers and their teams can quickly and easily:
  • understand UK capabilities to deliver their study at all stages of the protocol development and delivery pathway
  • connect with the right part of the system to help them at the right time
  • access the network of expertise and resources available to create a package of support to deliver studies efficiently
• MHRA, NICE, AWTTC and SMC will work with partners across the UK to develop ILAP as an effective route into the UK research system, particularly through the development of a support toolkit
• the further development of IRAS will also provide navigation and signposting through the research journey, directing applicants to relevant guidance and advice. Through interfaces with other systems it will reduce burden and duplication

Research delivery enabled by data and digital tools

The UK’s health data offering is one of our global strengths due to our national health systems and cradle-to-grave healthcare records. Investing in data and digital tools, and making ethical use of them to support clinical research, for example by making it easier to recruit and follow-up participants, increases the efficiency and effectiveness of the clinical research process. These tools also increase the resilience and sustainability of the healthcare system and reduce the burden on the NHS workforce.

Progress in Phase 1:

• the data strategy for health and social care in England was published in June 2022
• up to £200 million committed to support NHS-led health research (subject to business case) was announced on 2 March 2022 to invest in health data infrastructure to support research and development in England, with parallel activity in the devolved governments

• the NHS-Galleri trial demonstrated the potential for the use of healthcare data to support rapid, large scale recruitment to and delivery of clinical studies in the NHS. The Accelerated Access Collaborative (AAC), led by NHS England, coordinated the design and set up of a 2 part, real-world demonstration project involving clinical data capture from NHS Digital and NIHR, and was a demonstrator for the ‘Find, Recruit and Follow-up’ service and NHS DigiTrials. The trial has already passed the halfway point in their recruitment of participants, with over 100,000 enrolled following the launch in autumn 2021

• each delivery partner funded as part of year one of the ‘Find Recruit and Follow-up’ service launched Minimum Viable Products (MVPs) of their services including: NHS DigiTrials, which has successfully facilitated 28 active trials through its service with a further 8 in application and 12 in pre-application; NIHR CRN launched its early stage ‘concierge’ service, with 2 companies and 4 data service providers as early users; and HRA, which agreed an approach to review by the Confidentiality Advisory Group which will enable more efficient study set up in future. In addition, the MHRA Clinical Practice Research Datalink (CPRD) has launched SPRINT (Speedy Recruitment into Trials), a data-enabled research service that facilitates rapid feasibility and patient recruitment into industry sponsored phase 2 to 4 trials across the UK
• making use of real-world data (RWD) in and for clinical research is now a reality, supported by MHRA’s published guidance. This is the start of a series of guidelines to provide general points to consider for sponsors planning to conduct clinical research using RWD to support regulatory decision making

Phase 2 commitments

The next 3 years will see a revolution in how we use data across the health system. We will go further in utilising innovative data-driven methods and digital tools to transform the way we design, manage and deliver people-centred clinical research studies across the whole of the UK. We will achieve this by increasing the use of data and digital tools in recruitment and follow up, and by improving access to data via Trusted Research Environments (TREs: a type of Secure Data Environment, secure spaces where approved researchers can access rich, linked datasets) and through increased partnership working across the UK health data ecosystem.

We are very clear that the opportunity to use health data must be done in a way which is secure and trusted by members of the public, so governance and oversight processes must be both as efficient as possible and transparent, robust and trustworthy. Public trust and understanding of how data is being used to support research continues to be critical in developing appropriate activities. We will be working together to consider how to implement recommendations from the Goldacre Review, and ensuring that all work is supported by comprehensive public involvement and engagement activity.

To improve study planning, recruitment and follow-up:

• the Find, Recruit and Follow-up service will work across the 4 administrations to consider how activity can be expanded to include SAIL, Scottish Health Research Register, data infrastructure in Northern Ireland, NIHR BioResource and other key national data infrastructure, increasing opportunities for people to quickly and easily access research of relevance to them
• NHS DigiTrials and CPRD (via MHRA) will enable a significant increase in the scale of identification of people who match the eligibility criteria for specific studies in order that they can be given the opportunity to participate in research. They will also support increased use of routine healthcare data to streamline reporting of follow-up data, increasing predictability and releasing delivery capacity in the NHS
• in England, the Data for R&D Programme will invest in health data infrastructure for research and development, supported by comprehensive PPI and engagement throughout the programme, including embedded within its governance
• NIHR will invest in data and digital platforms such as Be Part of Research and NIHR BioResource, and provide the tools and support necessary to deliver virtual and decentralised studies. Increased interoperability between regulatory, NHS and NIHR platforms will enable further streamlining of processes for researchers
• in Wales, a digital recruitment programme will be developed through partnership between Health and Care Research Wales, SAIL Databank and the NHS Wales National Data Resource programme, to develop services that utilise data resources to drive research delivery. An Expert Working Group has been established to guide on the development of this ‘data for research’ programme. A pilot service has been funded to use SAIL data to provide rapid intelligence to aid placement of research trials in Wales to support most effective recruitment
• in Scotland, scoping work and stakeholder engagement is informing plans for developments to support increased use of NHS data and digital technology to accelerate clinical trial delivery, and for further development of the Scottish Health Research Register (SHARE) to support recruitment to health research studies. We will continue to support the already established regional NHS Scotland controlled data safe havens (Trusted Research Environments) and their collaboration with the newly established Research Data Scotland to support use of data in research. We will also look for opportunities to support research and innovation as part of the forthcoming Scottish Government Data Strategy for Health and Social Care
• in Northern Ireland, the RRG Taskforce data and digital sub-group will lead work to prepare the NI data infrastructure to support digitally-enabled trials and participate in UK-wide initiatives such as the ‘Find, Recruit and Follow-up’ service.

To improve access to data and TREs:

• over the next 3 years NHS England will build upon foundational investments made in 2021 and 2022 in an interoperable network of TREs. At a national level, we will expand the scale, scope and capacity of the NHS Digital TRE to enable more users to have timely and secure access to a range of national datasets. At a regional level, we will develop a small network of regional ‘Sub National TREs’ in England, each covering a population of more than 5 million citizens and enabling access to near real time, multimodal data particularly amenable to the development of AI algorithms
• the Data for R&D Programme within NHS England will expand the ability for researchers to access a range of rich linked genomic datasets, creating linkages across the various health data systems so that genomic data can be used to support innovation and patients and service users can benefit from the provision of innovative genomic healthcare. The Genome UK Implementation Coordination Group Data Working Group will lead work looking to link genomic datasets from across the UK, and federate these where appropriate, as set out in the Genome UK: shared commitments for UK-wide implementation 2022 to 2025
• in Scotland, we will continue to support the already established regional NHS controlled TREs and their collaboration with the newly established Research Data Scotland to support use of data in research
• in Wales, we will continue to invest and grow the internationally recognised expertise and TRE available via the SAIL Databank, offering national population coverage and secure access to billions of person-based records
• in Northern Ireland, the Honest Broker Service and the more recently established Northern Ireland TRE will be supported to further develop secure access to data for research. This will sit alongside a sustained public dialogue and progression of the enactment of secondary uses legislation to facilitate data access for research in Northern Ireland.

Connecting these developments into a coherent UK offer will bring added benefit, therefore to unite plans:

• the RRG programme will ensure strategic co-ordination of this work across the UK clinical research ecosystem, supporting progress and ensuring alignment of initiatives, as well as identifying key areas where we can go further within the next 3 years to take steps towards fully realising our overarching vision
• an RRG data and digital subgroup will be established to enhance collaboration across the sector and ensure people across the whole of the UK benefit from research delivered using data and/or digitally-enabled approaches

Governance, detailed plans and ongoing updates

The UK Clinical Research RRG programme will oversee the delivery of this plan, continuing to work in partnership with stakeholders across the sector and regularly revisit the original vision to consider any further actions needed to deliver on the 10 year vision. In doing so, we will ensure that the NHS is able to tackle the healthcare challenges of the future enabling people across the UK and around the world to benefit from better health outcomes.

Further information about the RRG programme, including our delivery partners and governance, are available on the dedicated Recovery Resilience and Growth website. Detailed summaries of our progress to date and our future plans will be published on the site on an ongoing basis, providing a central point of information and updates about the programme and our progress towards achievement of the vision. You can also sign up to receive regular email updates on our progress.

Given the scope of the work and the fast pace of change in clinical research, we will keep the specifics of this plan under review via the RRG programme and adapt delivery as needed. This flexibility will allow us to meet emerging challenges and ensure that the outcomes are aligned to the most pressing issues to realise our shared ambitions.

Progress will be measured by the RRG Programme Board and the Ministerially-chaired Oversight Group, ensuring we are delivering on the commitments set out in this plan and that they are having the intended impact on the UK clinical research system. Specific measures for success will be published on the RRG website later in 2022.

We will publish a Phase 3 plan in 2025 to 2026 to align with the next government spending review period. The Phase 3 plan will showcase our progress and lay out the next steps needed to ensure the vision is delivered.

Achievement of our plan will require action across the whole sector, but by building on the foundations of collaboration and partnership that we have created through RRG programme we can collectively work through current challenges and see this vision become a reality.