Leeds Teaching Hospitals NHS Trust Research and Innovation Strategy 2020-25 "An Always Event: Research and Innovation the Leeds Way"
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Agenda Item 13.2 - Research and Innovation Strategy
Leeds Teaching Hospitals NHS Trust
Research and Innovation Strategy 2020-25
“An Always Event: Research and Innovation the Leeds Way”
Why the NHS needs Research and Innovation:
Research and Innovation is one of the platforms of the NHS constitution as a key enabler to drive
improvements in clinical care. Benefits of clinical research and innovation to the NHS include:
• Research-active hospitals deliver better care (e.g. better CQC ratings) and have better
patient outcomes (e.g. lower mortality rates), with benefits not limited to those patients
who participate in research.
• Engaging in research may improve clinicians’ job satisfaction, can boost morale and can
reduce burnout.
• Increasing the academic content of medical posts may improve staff retention and
recruitment.
• Improved retention and engagement could potentially be cost-saving, for example through
reducing expenditure on locums and attracting increased investment from the private sector
to undertake clinical trials.
NHS organisations are central to the delivery of clinical, academic and industrially-led research that
requires the involvement of patients or clinical materials such as blood samples or biopsies to
advance understanding of disease. NHS organisations bring a highly complementary set of skills to
those found in academic and industry partners, allowing effective research collaborations to be
forged for patient, academic and economic benefit. Over the last 5 years we have carried out an
extensive review of the Research and Innovation function at Leeds Teaching Hospitals NHS Trust in
order to shape it to meet the needs of both academic and commercial partners in a rapidly changing
landscape.
Research active NHS organisations are not just beneficial for patients; they are beneficial for the UK
economy as research and innovation infrastructures can help businesses to develop new products
and gather the evidence required for regulatory approvals and market launch in international
markets. This link is articulated in the UK Life Sciences Industrial Strategy which sets out ambitions
for the numbers of clinical trials conducted in the UK to increase by 50% in the next 5 years, increase
the amount of collaborations between NHS organisations and industry partners, drive growth in the
digital sector through use of routinely collected NHS data and ultimately increase the pace of
adoption of new technologies into clinical practice. None of these ambitions are possible, nor are
the benefits realisable without NHS organisations as willing, engaged and equal partners. The Leeds
City Region has a unique industrial strength in the medical technology and digital sectors, so by
working collaboratively with local industrial partners the Trust does not just serve as a provider of
healthcare to its population, it can also actively support economic growth and job creation.
Research activity can be found in every Clinical Service Unit and we will maintain this where it is
apposite so to do to, so that every patient has the opportunity to participate in research. Over the
next 5 years we will support each Clinical Service Unit at LTHT to develop its own local research and
innovation strategy that reflect the needs of the services that it provides so that outputs from
research projects and innovation activities can be seamlessly adopted into every day clinical care,
making them strategic enablers for the organisation that drive long-term patient benefits, service
improvements and efficiencies.Agenda Item 13.2 - Research and Innovation Strategy Our vision Our vision for research and innovation at LTHT is simple: by 2025 we want every patient cared for by Leeds Teaching Hospitals NHS Trust and every member of staff to have the opportunity to participate in research in some way, making research a “always event” for the organisation. Delivery of this vision is underpinned by the following ambitions: 1. To be the best NHS Trust to deliver high quality clinical research To ensure that all patients can participate in research we need to ensure that our research delivery teams receive the right training, are fair, empowered, accountable, collaborative and patient centred. We will ensure that every member of LTHT staff has access to high quality research training through the Research Academy and that support and career development pathways are available for all professions and at every career stage. 2. To be the best NHS Trust to champion research (staff/patients/public) Research cannot be delivered in isolation; it requires buy-in from our staff, our patients and members of the public. We will ensure that research activities within LTHT are visible to all staff and patients and through a proactive communications and PPIE strategy reach out to members of the public across Leeds, West Yorkshire and the UK to engage them in research programmes being carried out at LTHT 3. To maintain and grow world-class clinical infrastructure and assets for research and innovation High quality research and innovation requires high quality infrastructure, both physical and digital. Working in collaboration with other teams in the Trust, our academic partners, industrial partners, charity partners and NIHR we will further develop the world class infrastructure required within the organisation so that programmes can be delivered at pace and scale. Our Priority Workstreams 2020-25 1. Our people, patients, public and partners Our underpinning philosophy is that “research is for all”, whether that is a patient being treated at LTHT who chooses to be a part of a research project or a member of staff who wants to run a research project. 1.1 Visibility We will increase the visibility of research to patients and members of the public so that patients feel empowered to ask about opportunities for participating in research at LTHT. We will enhance physical signage and digital visuals relating to research throughout the organisation and implement a communications strategy that ensures information relevant to patients about research is reaching them in a language that is accessible and engaging. We will further professionalise our PPIE function to provide a co-ordinated approach to Patient and Public Involvement and Engagement (PPIE) across the organisation and work with our NIHR Patient Research Champions to support their activities and engage more patients in research activities. 1.2 Engaging our staff Evidence has shown that an NHS workforce that has the time and opportunity to participate in research and innovation is a more engaged workforce, with benefits for staff recruitment and retention. Almost two thirds (64%) of doctors surveyed by the Royal College of Physicians say they would like to spend more time on research. We will further enhance the profile of research and
Agenda Item 13.2 - Research and Innovation Strategy innovation across all staff members at LTHT, broadening our engagement activities across all staff groups and including medical and non-medical undergraduates and unregistered staff to showcase the importance of research in a career in healthcare. In particular, we will work with partners to look at ways in which we can support undergraduate modules on research in the NHS with our partner academic organisations and look at opportunities for research internships during holidays to give students first-hand experience of participating in research. We will increase the visibility of research during the LTHT staff induction process and create a bespoke “introduction to research” course for all staff who want to learn more about research and the support available in the organisation. We will also create secondment opportunities for staff members to allow them to undertake short research projects in order to develop their skills prior to embarking on a formal research career, implementing “pump priming” schemes to support those starting out on their research career, building on the success of the University of Leeds HCAP programme. We will particularly focus on increasing our engagement with Junior Doctors, providing more bespoke training on research at an earlier stage in their career, signposting towards academic careers where appropriate to support the development of future Clinical Academics, and opportunities to participate in research projects. Given the emerging evidence that a research- active culture leads to improved recruitment and retention of clinicians, introducing a research component across all posts could make these positions more attractive, as well as enhancing the retention of nurses and other staff in the longer term. 1.3 Research and Innovation training We will further invest in our Research Academy to grow and develop our research workforce. We will develop an education programme that complements the local and national NIHR education programmes to reinforce the existing skill base, maximise performance against national Key Performance Indicators (KPI’s) and prepare the workforce for future developments in the healthcare sector. We will improve the quality of learning, education and training in research to enable skills required to deliver high quality and ethical research. We will also explore opportunities for mentoring staff where appropriate to support their career development. Succession planning, leadership training and the creation of career pathways specifically for LTHT Research Delivery staff will become embedded within our structures. Through these activities we will become a regional incubator for research delivery training and an internationally recognised centre of excellence for clinical research education to develop the next generation of clinical research leaders across a wide spectrum of career pathways. This will allow us to increase the number of Principle Investigators and Chief Investigators from medical and non-medical backgrounds at LTHT and the wider region, and allow us to more appropriately signpost to University partners where individuals wish to undertake an academic career. In addition to developing our PI’s and CI’s, we will also invest in developing our Research Delivery Staff and our Research Management workforce, developing a suite of CPD-accredited training courses that develop the specialist skills needed to work in a clinical research environment so that staff have appropriate career development. We will work in partnership to ensure that the training courses run by the Research Academy are available to other NHS organisations and to industry partners. By supporting research skills development across other NHS organisations we can help ensure that patients in other NHS Trusts have access to research. We also believe that by having industry representatives (particularly from the medical technology and digital sectors) trained alongside NHS staff we can develop a common understanding of how research is carried out in the NHS that will help break down barriers and facilitate new research and innovation opportunities from which our patients can benefit. To support the staff with innovative ideas for new technology-
Agenda Item 13.2 - Research and Innovation Strategy
led innovations, we will develop and launch an “Innovating the Future” programme in 2021 to
support them through the validation and development of these ideas.
2: Developing our Research Operations
Like other clinical services at LTHT, Research and Innovation is managed by a senior management
triumvirate of a Clinical Director, Head of Nursing and Operations Director. The Research and
Innovation team are currently moving to a model where the Research and Innovation function
provides a managed research service for the organisation; this restructure will be completed in
March 2021 and enable a more transparent and efficient use of finances and delivery teams
associated with research. Within that model, core functions such as research governance, study
setup and business development are hosted in the central Research and Innovation team.
Management of NIHR funded programmes and other major projects report into the Operations
Director and leverage support from other core teams as required to maximise operational efficiency.
As with all other parts of the NHS, we need to ensure that our systems and processes operate in an
efficient manner so that resource utilisation is maximised, and our professionally registered research
delivery teams maximise the amount of time they spend with patients, rather than carrying out
administrative tasks. We will develop and implement continuous improvement plans using the
Leeds Improvement Method with all our research teams and support departments to help enable
this and streamline research delivery. In this way we will be able to increase our recruitment of
patients into research studies within existing resource availability.
Over the next 5 years we will continue to transform our approach to managing research at LTHT.
We will:
• Continue to develop our award-winning use of digital technologies to track and monitor
performance against national targets so that we can better plan where resource is required
to maintain our place as a leading recruiter into clinical trials nationally.
• Introduce a pan-organisational team and standardised processes for setting up research
projects in the organisation so that studies are set up rapidly and we can maximise the
amount of time available for recruiting patients into studies.
• Introduce standardised practices for trial management so that best practice is followed
across the organisation and ensuring that we fully recover NHS costs associated with
research delivery.
• Enhance our support to NHS staff for developing grant applications so that new PI’s and CI’s
are not working in isolation and have access to specialist knowledge to help them develop
high quality grant applications.
• Continue to develop our national profile and role, becoming a national reviewer for research
contracts and costing templates and supporting the development of national approaches
and initiatives.
• Enabling our support services to develop the skills needed to enable the delivery of new
trials in the Trust - e.g. Artificial Intelligence, Advanced Therapies and Real-World Data
studies.
• Develop processes for identifying staff with innovative ideas that will help improve care and
signposting them towards appropriate support and collaboration partners to enable their
development.Agenda Item 13.2 - Research and Innovation Strategy
3. Collaboration, Business Development and Innovation
We will work more closely with our external partners to ensure that the mutual benefits from
collaborating on research programmes are realised. We will further develop our strong relationship
with the University of Leeds through the Joint Partnership Board, developing joint strategic
initiatives to grow clinical research and innovation programmes across the 2 organisations. We will
also further develop our existing partnerships with other local academic organisations, including
Leeds Beckett University and the University of York and seek out the best academic expertise
nationally to work with our staff and patients wherever possible to ensure that our patients benefit
from world-class research. In this way we will create an environment for enhanced collaboration
between University partners and medical and non-medical staff to develop research ideas.
The Life Sciences Industry Strategy highlighted the opportunity for the NHS to go beyond its
traditional role as a customer for innovative medical products and move to becoming a co-creator
and willing collaborator to more proactively support their development and evaluation. In 2019 we
established a Clinical Innovation System (see Figure 1) that uniquely works right along the innovation
pathway from idea generation to adoption/deployment into practice. Over the next 5 years we will
operationalize and embed this as part of core business within LTHT, providing a mechanism through
which Trust staff with ideas can be supported in further developing those ideas, and acting as a
gateway for industrial and academic partners to work in partnership with LTHT staff to ensure that
innovative medical devices and diagnostics are developed in a way that is fit-for-purpose. Over the
next 5 years we will support >200 projects through our innovation system so their benefits reach
patients faster than they otherwise might have and the Trust remains seen as a leader in Innovation
nationally.
Figure 1: The LTHT Clinical Innovation System
LTHT remains a key partner for the pharmaceutical and biotechnology industries in clinical trials of
novel therapeutics and through our work as part of the Northern Alliance Advanced Therapies
Treatment Centre programme, we have developed capabilities and infrastructure that allow clinical
trials of Advanced Therapies (ATIMP’s), opening up the potentially transformative benefits of such
therapies to patients in Leeds. However, there are obvious benefits to patients to come from
partnering with industry across a whole range of other technology areas, including the rapidly
growing world of Artificial Intelligence and Digital. We will build on existing infrastructure that
supports engagement with the medical device and diagnostics sectors and where advantageous, we
will work with our academic partners to add value to partnerships between LTHT and industry
partners by supporting access to additional expertise that will help accelerate the pathway toAgenda Item 13.2 - Research and Innovation Strategy
adoption through our clinical innovation system so that well-evidenced technologies can be adopted
into practice for patient benefit more rapidly.
We will take a proactive approach to developing long-term partnerships with industry, both UK-
based SME’s and large multinational companies to help accelerate the pathway to implementation
in the NHS of new therapeutics, diagnostics, medical devices and digital technologies, and to make
such technologies available to patients through research before they are available commercially so
that they can benefit from their use. Over the next 5 years, we will therefore target the
development of a wide range of partnerships with industry across our clinical specialties in the
following areas:
• Pharmaceuticals
• Biotechnology
• Advanced Therapies
• Medical Devices
• Diagnostics
• Artificial Intelligence and Digital
We believe that we have much to both share with and learn from other research-intensive hospitals
globally, so by 2025 we will look to establish at least 1 international partnership with a major non-UK
research centre in order to facilitate international collaborations and knowledge transfer for the
benefit of our patients.
4. Research Governance
Robust and effective research governance is fundamental to the safe and high quality conduct of
research and it is crucial that our patients are confident that the research they take part in is
conducted to the highest standards. Our research governance team, in partnership with the
University of Leeds, has oversight of all research taking place at LTHT to ensure it is governed clearly,
robustly and in compliance with research governance requirements and regulation.
We will build on strong foundations to improve both our oversight of research and our support to
investigators. From 2020 -2025 we will:
• Strengthen the joint LTHT/University of Leeds research governance framework which
provides assurance to both organisations of satisfactory oversight of research activity
performed within our organisations. We will do this by regular review and improvement.
• Review and reshape the research governance workforce to ensure we have a lean,
integrated workforce to deliver effective operational management of activity, priorities and
risks related to the governance of research at LTHT.
• Develop a high quality service for investigators offering support throughout the research life
cycle, from early planning, set up and conduct of research, to close down, archiving and
publication. We will do this through the creation of a comprehensive suite of SOPs,
guidance and training in research sponsorship and governance.
• Maintain a quality management system to ensure continued compliance with the UK clinical
trials regulations (2004) for drug trials.
• Build expertise in specialist and emerging areas to support research involving artificial
intelligence, health informatics and medical devices.Agenda Item 13.2 - Research and Innovation Strategy
• Ensure information about all interventional research is made public in line with the Health
Research Authority’s vision for transparency in research.
• Connect with research governance teams nationally to create a network of peers so that
Leeds shares expertise, adopts best practice and contributes to the national agenda.
We will achieve these aims by investing in our team and working with and drawing on the expertise
of delivery, research academy, quality assurance and trials management colleagues across the Trust
and the University of Leeds.
5. Digital and Information Technologies
5.1 Research Informatics
Digital technologies have significant potential to make the enablement, management and delivery of
research far more efficient, reducing some of the administrative burden associated with research.
We have recently started on this journey with our advanced use of EDGE and the development of
“OneForm”, a system that streamlines the setup process for clinical trials within LTHT. However, we
recognise that the opportunities are far wider than this, particularly in terms of identifying
appropriate cohorts for recruitment into trials. In partnership with the LTHT Digital and Informatics
team (DIT) we will develop and execute a programme of work to digitally enable research within the
Trust so that research systems are integrated with the Trust’s Electronic Patient Record system and
to maintain compliance with guidance around EPR systems for research purposes. The first step in
this will be the creation of a digital enablement strategy for research at LTHT which identifies the
opportunities and mechanisms by which they will be delivered. We will also work with DIT to ensure
that the requisite digital infrastructure is in place to allow our strategy to be delivered.
5.2. Real-world data
The use of routinely collected clinical data (real world data) for research will continue to be a major
source of interest and activity over the next 5 years and we believe that that understanding the
trends and insights that might be hidden within such data will be transformative for healthcare in
the future. Over the next 5 years we will work with partners to develop a portfolio of high quality
research which utilises real-world datasets supported by strong governance and processes for de-
identification so that all projects we carry out are done so within the requisite legal frameworks,
including all data protection and state aid laws. We will consult with patients and members of the
public to inform the development of our strategy and processes in this area and fully respect patient
opt-outs where they have been received.
Between 2020 and 2025 we will continue to develop our capabilities and processes to develop an
efficient function that provides de-identified datasets for research purposes with world-leading
governance standards.Agenda Item 13.2 - Research and Innovation Strategy
6: Investing in our Infrastructure
In 2017 the Research and Innovation Centre opened on the St. James’s campus, bringing many of the
core research and innovation functions at Leeds Teaching Hospitals, the University of Leeds and the
NIHR Clinical Research Network for Yorkshire and Humber together under one roof for the first time.
This has been transformative for working practices and visibility of research and innovation across
the organisation. This building sits at the heart of a “Research, Innovation and Education” quarter at
St. James’s alongside key University of Leeds infrastructure. The Leeds General Infirmary campus is
at the heart of plans to establish an “Innovation District” in Leeds and the £600m “Building the Leeds
Way” redevelopment of that site brings with it the opportunity to create an Innovation Centre in
which we can bring together clinical innovators and businesses in new ways to enable rapid
development of innovations that fit with the needs of the population of West Yorkshire through an
“Innovating the Future” programme that will support and develop staff with innovative ideas. This
major programme also brings with it the opportunity to strategically engage with industry partners
to co-develop innovative solutions that meet the needs of a modern 21st Century Hospital
Between 2020 and 2025 we will:
• Open a new £3.3m Clinical Research Facility for experimental medicine on the St. James’s
campus in 2020, providing academic and industry partners with world-class estate in which
early-phase clinical trials of new drugs, devices and diagnostics across all specialities can be
carried out.
• Redevelop our existing adult Clinical Research Infrastructure at the Leeds General Infirmary
site to increase capacity and enable additional opportunities for patients in specialties at
that site to participate in research
• Open a new Clinical Research Facility within the new Leeds Children’s Hospital in 2025,
doubling the number of beds we have available available for world-class research that
involves our younger patients within the Trust.
• Expand our provision for clinical research and outreach into the community in the Clinical
Research Centre at Chapel Allerton Hospital. This will sit integrally with the new £1.5m
research MRI scanner and clinical investigation and biopsy suite that commenced operations
in 2019.
• Work with the Pathology CSU to leverage the assets available within the new Pathology
building (due to open in 2021 on the St. James’s campus) for testing of new diagnostic tests
and technologies, supporting Leeds position as a leader in supporting the In Vitro
Diagnostics industry
• Continue to support and leverage investment into our world-class digital histopathology
facilities, a multi-million pound investment, where translational research and clinical care sit
side-by-side, allowing rapid translation of research outputs into practice. We will create a
Digital Pathology Innovation Centre on the SJUH campus (opening in 2021) within the
Research, Education and Training Quarter which will allow clinicians, academics and industry
to collocate allowing the rapid development and evaluation of innovative technologies that
will allow the benefits of this technology to be leveraged globally.
By 2025, we will have completed an investment of >£10m into research and innovation estate at
LTHT over a 10 year period to create world-class facilities in which world-class research and
innovation can flourish for the benefit of LTHT’s patients and the UK economy, in line with the UK’s
Life Sciences Industrial Strategy.Agenda Item 13.2 - Research and Innovation Strategy
Key Performance Indicators
Key Performance Measure Contributing Reporting How evidenced
Indicator Priority Frequency
Workstreams
Patient Number of patients recruited ALL Annual Patient recruitment reporting
participation in into research studies from research teams into EDGE
research
Number of research Number of research projects 1.1, 1.2, 1.3, 2, Annual Data from EDGE
projects at LTHT “live” (i.e. open to 3, 5.1
recruitment or in follow-up).
Leveraged income Amount of external income 1.1, 1.2, 1.3, 2, Annual R&I Financial Data
leveraged for research and 3, 4, 5.1, 5.2
innovation projects from
external sources
Study setup (a) Median time to local 2, 5.1 Quarterly Data from EDGE / R&I systems
approval (CCC) in the
organisation
(b) Median time to first
patient recruited
Restructuring Programme of integration ALL Annually Research delivery workforce and
Research and completed budgets integrated into Research
Innovation function and Innovation function
Recruitment to % of studies recruiting to time 1.1, 1.2, 1.3, 2, Quarterly Data from EDGE
Time and Target and target in 4, 5.1
(a) non-commercial studies
(b) commercial studies
Patients Engaged in Number of patients actively 1.1 Annual Number of patients participating
PPI activities involved in PPIE activities in a PPIE event in a 12 month
calendar period
Developing Number of LTHT staff acting 1.2, 1.3, 2, 3 Annual Data from EDGE
research and as Principal Investigators (PI’s)
innovation active on research studies
staff (a) Medical workforce
(b) Non-medical workforce
Number of GCP-trained staff 1.2, 1.3, 2 Annual Data from EDGE
in the organisation
Number of research grant 1.2, 1.3, 2, 3 Annual Data from Grants tracker
applications submitted
Industry Number of industry partners 1.1, 3 Quarterly Data from R&I CRM system and
partnerships working on research or EDGE
innovation projects with LTHT
Strategic partnerships that 1.1, 3 Annual Signed agreements
deliver mutual benefit to LTHT
and industry partner
Academic Number of academic 1.2, 1.3, 3 Annual Signed collaboration agreements
Partnerships organisations (national and
international) in active
research collaborations with
LTHT staff members
Sponsor review Time for sponsor review of 2, 4 Quarterly
LTHT-sponsored studies
Reform our research 2, 4 Quarterly
governance processes in
collaboration with the
University of Leeds, creating a
comprehensive suite of SOP’s,Agenda Item 13.2 - Research and Innovation Strategy
guidance and associated
training by 2025 to provide
researchers with a whole
project life cycle support
service.
Response times for review
and advice on new studies are
responded to
LTHT sponsored
interventional trials registered
to publicly accessible
database within regulatory
timelines
Staff Training Number of LTHT staff 1.2, 1.3 Annual Registers of course attendees
attending LTHT Research
Academy courses
Digital enablement Creation of a digital 2, 5.1 Annual Strategic plan developed and
of research enablement strategy shared with RET
Delivery of digital strategy 5.1 Quarterly Milestones in strategic plan
Real World data Data requests fulfilled within 5.2 Quarterly Work records from team
8 weeks
Research Open our new Clinical 6 Annual CRF operational and being used
Infrastructure Research Facility at St. for patient care
James’s University Hospital
Open a Digital Pathology 6 Annual Centre open and staffed
Innovation Centre
Open a new CRF within the 6 Annual y CRF operational and being used
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