NIHR Clinical Research Network Study Support Service, Louise Thornhill (Presentation)
MHRA Risk-Adaption and the new Clinical TrialsRegulation Kathleen Meely (Presentation)
The Research Fayre also provided a wide range of Posters.
Theme: Embracing a Changing Landscape
A: The perspective of Health Care Professionals’ towards undertaking Research within the National Health Service Amy Jordan, Research and Development Officer, Cwm Taf University Health Board
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Directly Relevant to: Ths session is relevant to all Health Care Professionals, at any level but more specific to secondary care as we undertook a cross-sectional survey across all health care professions across three health-boards. The research was not limited to a certain group of professionals as we recognised that there was an unmet need to explore the views and opinions of those who are not traditionally known to undertake or lead on research for example administration staff.
Objective/initiative: Explore the current research culture of the NHS Are there any barriers to undertaking research in the NHS Can these be addressed to improve the research experience Are there any facilitators to undertaking research in NHS Can these be used and promoted to encourage more research activity To assess current position with regards to the experience and research ambition of HCPs
Aims: To explore the beliefs and understanding of health research from the perspective of the Health Care Professional (HCP) and seek their view on the research culture across the National Health Service (NHS).
B: Improving access to NIHR trials in critical care Natalie Pattison -Senior Clinical Nursing Research Fellow, The Royal Marsden, Nishkantha Arulkumaran-Clinical Research Fellow, University College London, Sally Humphreys–Research Sister, West Suffolk NHS Foundation Trust, Tim Walsh-Professor of Critical Care, University of Edinburgh
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Directly Relevant to: Clinicians, Researchers, Research Nurses, R&D Managers, R&D Directors
Objective/initiative: To identify facilitating factors and barriers to enrolling patients into established ICU clinical trials within UK National Health Service (NHS) critical care units.
Aims: To identify facilitating factors and barriers to enrolling patients into Intensive Care Medicine clinical trials within the United Kingdom
C: Using electronic health records in research Lisa Hyatt, Research Nurse, Karen Ward, Senior Research Nurse, Sarah Williams, Associate Director or Research and Clinical Effectiveness, Meg McConnell, Product Specialist, Saleha Quadri, Product Specialist, Glen Wale, Head of Information Systems Sadie Bell, Head of Information Governance Solent NHS Trust
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Directly Relevant to:
Organisations wishing to move to electronic health records (eHR) for recording research-related patient care.
Move to recording research-related patient care in the trust’s single eHR in line with the MHRA (Sept 2015) position statement and guidance on eHR.
In late 2015, Solent NHS Trust decided to move its clinical research activity onto an electronic patient record system, used by the majority of the Trust. This happened immediately after a Trust wide switch to a new eHR (Systm1). Following approval via Trust governance, the ‘build’ commenced in February 2016, and the system ‘went live’ in April 2016. This presentation will outline the processes for obtaining governance assurance and approval, a brief overview of the infrastructure, our experience to date (the advantages and lessons learned), and how it has been received by study teams, and colleagues in the pharmaceutical industry.
Improving access to research and pt safety by including clinical research participant notes on an eHR system where all clinicians involved in care can see that a patient is on a clinical trial
Improving efficiency via ‘less paper’ and notes accessible anywhere across multiple community sites
Working with systems managers, the system vendor, information governance and research nurses to build an instance of the eHR system that was relevant and appropriate for recording research-related patient care
Ensuring that eHR are GCP compliant and meet MHRA guidelines
Increasing visibility of research across all Trust services (research becomes a formal clinical team)
Allowing access to GP records in local areas.
Aligning this project to an ‘opt out not into’ being contacted for research via flags on the eHR
Highlight research participants to clinicians to raise awareness of the need to report adverse events
Using the functionality of the eHR to manage team working practice through creating ‘caseloads’
D: Developing in times of change Vicki Conroy, Senior Clinical Research Nurse & Ian Venables, Senior Clinical Trials Coordinator, Adult Oncology Research Team, Central Manchester University Hospitals NHS Foundation Trust
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Directly Relevant to: All research teams, staff at all levels
Objective/initiative: We identified 4 strategic areas where we could improve our performance and develop patient care
Recruit and treat more patients and improve patient care
Increase our commercial & non-commercial income
Become the leading recruiting site to Haematology Oncology trials in the North West
Implement Research Nurse led clinic
Aims: To create discussion and dialogue within research team monthly meetings, to enable objectives and goals to be set, and to facilitate the planning and management of research within the department over the next two years
Theme: Enabling Growth
A: Breaking down the barriers – how can NHS staff be supported to be research active? Gail Melvin BSc(Hons), MRes. Research Manager, Leicestershire Partnership NHS Trust
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Directly Relevant to: All NHS staff, especially those with an interest in nurturing research enthusiasm, building research capacity and with responsibility for capacity building
Objective/initiative: Qualitative data was collected using focused ethnography. Interviews were undertaken with staff interested in research who were not researching. Factors enabling active researchers were identified in a focus group.
Aims: A research project in one Trust aimed to identify strategic and operational approaches to enhancing clinical research capacity in the NHS by investigating the perspectives of staff as to the barriers and facilitators.
B: The Role of the Clinical Trials Set Up Specialist: From Protocol to Patient Sheela Medahunsi, Clinical Trials Set Up Specialist, Oncology Haematology Clinical Trials (OHCT) Guys and St Thomas’ NHS Foundation Trust
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Directly Relevant to: NHS Hospitals conducting clinical trials, Clinical Trial Sponsors, Contract Research Organisations
Objective/initiative: Building on research presented at the NCRI conference 2015, this poster session will demonstrate the role of the Set Up Specialist (SUS) in delivering new trials and potential novel treatments to patients.
Aims: The SUS oversees the pathway of a proposed study to an R & D approved, site activated trial. Providing a streamlined process for establishing new studies in a timely manner, the SUS assesses new trials appropriately to ensure their effective conduct. To evaluate the impact of this role, we identified how the SUS assists the OHCT in growing its commercial portfolio.
C: Listening to research conversations Lee Tomlinson. Senior Research Nurse
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Directly Relevant to: Organisations seeking to engage more front line staff in research activity, harnessing their enthusiasm and developing their research know how.
Objective/initiative: Develop a research active culture. Allay the fear of research. A collaborative approach to research. Trading skills to support projects.
Aims: To grow a research active workforce and increase research expertise and capability.
D: Developing a Centre for Rare Diseases to maximise Patient Experience and Research Opportunities Joanna Gray Clinical Manager NIHR/WT Birmingham CRF, University Hospital Birmingham NHS Foundation Trust Joanna Plumb, Head of R&D Operations, University Hospital Birmingham NHS Foundation Trust
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Directly Relevant to: Clinical Research Managers, R&D Managers, Clinicians / Research Nurses
Objective/initiative: To understand the drive for new collaborations between NHS service and research delivery To showcase the use of existing infrastructure in delivering service and research as a collaborative model Cohort based studies
Aims: To provide an insight into the Institution of Translational Medicine ( ITM ) Centre for Rare Diseases model delivering a one stop shop for clinical care and integrated research opportunities
Theme: Integration & Partnership
A: Partnership working to support primary care research and evidence based practice – example from the Cross Staffordshire and Shropshire ReDIE Group Helen Duffy, Mark Stone, Sally Parkin, Nina White, Colin Stanford, Louise Warburton, Rhian Hughes Research Institute for Primary Care & Health Sciences, Keele University. NHS Stafford & Surround Clinical Commissioning Group. NHS North Staffordshire Clinical Commissioning Group. NHS Telford & Wrekin Clinical Commissioning Group. NHS Shropshire Clinical Commissioning Group
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Directly Relevant to: R&D Managers, Commissioning Leads, Service Managers, Academic leads
Objective/initiative: To establish a group of research champions/leads who would facilitate a framework for a joint approach to primary care research (design, delivery and implementation)
Aims: To demonstrate how partnership working across organizational boundaries can facilitate solutions and a joint approach to research delivery and implementation
B: Integrating innovation across health and social care: The Solent Care Home Research Partnership Dr Sarah Williams and Chantel Ostler Solent NHS
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Directly Relevant to: Community Trusts, Social Care providers, Research Nurses, R&D Managers, Academic researchers
Objective/initiative: The CHRP objectives were to build relationships with Care homes in the Portsmouth area with a view to sharing our research knowledge and skills and providing more people with the opportunity to be involved with new and innovative ways of working.
Aims: The aim of the Solent Care Home Research Partnership (CHRP) is to integrate the delivery of clinical research across health and social care settings.
C: Inter Trust Collaboration in Dementia Research. The Good, the Bad and the Downright Impossible. Dr Ruth Newman Senior Clinical Studies Officer, Devon Partnership NHS Trust
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Directly Relevant to: This session is relevant to all participants who want to learn from an example of good practice and provide more research opportunities for their patients. In particular it’s helpful for NHS providers who want to set up a collaboration across organisations to achieve : 1. An increase in the number and type of studies available to patients; 2. Increase recruitment 3. Improve delivery.
Objective/initiative: 1. To enable attendees to understand how collaboration can lead to increased research activity. 2. To enable delegates to identify how barriers [ actual and perceived] can be overcome. 3. To encourage attendees to consider forming a collaboration .
Aims: This session will present the experience of building a collaboration , the Devon Dementia Collaboration [DCC] between a large Acute Trust [Royal Devon and Exeter NHS Foundation Trust , RDE] and a Community Mental Health Trust [Devon Partnership NHS Trust, DPT], to deliver dementia studies. It will describe how working together enabled DCC to deliver the complex multidisciplinary methodologies of neurodegenerative disease studies [commercial and academic] by combining resources : facilities , infrastructure, experience and specialist staff. The positives and negatives of DCC will be shared including finances and recruitment.
D: Initiation of a joint Research & Development Officer role shared between an NHS Foundation Trust and a University Robert Hughes, R&D Officer, Medway NHS Foundation Trust
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Directly Relevant to: NHS Trust R&D staff. NIHR staff. University staff, in particular Business Development Managers
Objective/initiative: To establish a Research & Development officer role shared between the University and the Hospital to facilitate collaborative research
Aims: To develop collaborative research between Medway NHS Foundation Trust and the University of Greenwich
Theme: Patient Centered Research
A: Starting the Conversation: A Community Arts Approach Rebecca Pritchard, University Hospitals Trust Leicester
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Directly Relevant to: Anyone developing involvement and engagement with patients and the public (PPIE)
Objective/initiative: To get people who weren’t research aware talking about medical research generally and the work of the three biomedical research units in Leicester/Loughborough particularly. This was both directly in terms of the artists and researchers working on the call and indirectly in terms of the people attending the exhibition.
Aims: Open a (multi-media) conversation about research with a “cold” group
B: How to Embed Research PPIE in an Acute Hospital Trust Setting. Amanda Datson, Research Feasibility and Communications Manager Michelle Hill, Research Office Manager Joanne Palmer, Research and Data Officer Royal Cornwall Hospitals Trust
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Directly Relevant to: Colleagues working in NHS research
Objective/initiative: Raise awareness of the importance of PPI to all research staff and embed PPI engagement as part of routine practice. Increase the patients and public knowledge of research taking place in the NHS trust and provide opportunities for patients and public to engage in research activities.
Aims: An initiative to raise awareness and provide opportunities for patients, public and staff to engage and contribute to NHS research activities in an acute hospital in the South West.
C:An Evaluation of Patient and Public Involvement in designing and delivering a research project Joanne Palmer Msc , Bsc(Hons) Research Information & Data Officer Jennifer Wingham PhD, BNS (hons), RGN Senior Clinical Researcher Royal Cornwall Hospital
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Directly Relevant to: Researchers, R&D staff and patients & public
Objective/initiative: To evaluate the patient and public involvement (PPI) during the REACH HF programme, seeking patient & public members and research teams perspectives on taking part.
Aims: To evaluate:
The quality of the processes of involvement
The contributions made by PPI group members
The impact of those contributions on the members themselves, the research team and the research itself
Identify what worked and what did not to inform future PPI work
D: Patients’ perspectives of Plain English Summaries in the National Institute for Health Research Journals Library Emma Kirkpatrick, Clinical Trials Coordinator, Southampton Clinical Trials Unit; David Wright, Director, Merle Wright Consulting Limited; Liz Brindley, Research manager, NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC); Elaine Williams, Director of Research, delivery and impact, NETSCC; Ruairidh Milne, Professor, NETSCC
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Directly Relevant to: Researchers, R&D staff and patients & public
Objective/initiative: Plain English Summaries (PESs), providing brief descriptions of research in non-specialist language, are a useful means of ensuring that research results are accessible and understandable to patients and the public. We will present findings from a study which assessed ease of reading and understanding of PESs produced by research teams compared with those produced by an external writer. The research was conducted as part of Research on Research which is an internal programme of work contracted under NETSCC.
Theme: Impact & Dissemination
A: Showcasing Trust research outputs: launching a freely accessible institutional research publications repository at the Royal Devon & Exeter NHS Foundation Trust. Pamela Geldenhuys, Acting Library Manager & Kate Newell, Reader Services & Research Support Librarian – Exeter Health Library, Royal Devon & Exeter NHS Foundation Trust.
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Directly Relevant to: All researchers, R&D staff and R&D managers
The Trust R&D department needed a quick and easy way to gather research publications data for their annual reporting. Historically this had been a time-consuming and laborious task. R&D collaborated with the Trust library service and together they launched an online institutional research repository using third party hosted software. Publications data is now collected and added to the research repository on a weekly basis, so that the data is ready to export as and when required. The repository also has the capacity to archive files such as full-text journal articles, conference abstracts, posters, images etc.
The biggest advantage of the repository is that all the publications data and associated files can be made freely available online – and therefore visible and accessible to researchers, patients, members of the public, providing a showcase for all the Trust’s research outputs, as well as being a data management tool behind the scenes.
This poster explains the process of developing, implementing and launching the institutional repository for any Trust which may be interested in doing the same.
Aims: To share our experiences of developing a tool to make Trust research publications data easy to collect, manage and make freely available via the RD&E Research Repository: http://rde.openrepository.com/rde
B: Strategies for dissemination of research information to primary and community care stakeholders and engaging Clinical Commissioning Groups (CCGs) in Norfolk & Waveney Gosia Majsak-Newman and Helen Sutherland on behalf of Norfolk and Suffolk Primary and Community Care Research Office
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Directly Relevant to: Predominantly Primary Care research support teams and those who support CCGs, but may have wider relevance.
Objective/initiative: To share information on local research activities and findings via newsletters, presentations, office website and annual report in a format acceptable to CCGs.
Aims: The Norfolk and Suffolk Primary and Community Care Research Office is committed to promoting research and to sharing the results of studies that may be of interest to CCGs locally. We aim to engage CCGs to support them in their duty of promoting research, using evidence in commissioning and meeting treatment costs of research.
C: Growing research in a Welsh public health organisation (The Englishman who went up a hill and came down a mountain) Mark Griffiths, R&D Manager, International Projects; Laura Rossiter, R&D Governance Officer; Ceri Smith, R&D Administrative Officer Public Health Wales
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Directly Relevant to: Public Health Researchers and R&D Offices with an interest in increasing public health portfolio studies
Objective/initiative: To present the recently developed Public Health Wales Research Strategy, and discuss how its implementation will help to facilitate the growth of research within an organisation that has often focused more on service delivery. The session will also highlight how the R&D Office is helping to create effective internal structures to support an increased focus on research and increased research activity across the organisation, and how the Research Strategy integrates with the wider Integrated Medium Term Plan, NHS Walesí response to the major challenges it faces today. The final key objective is to make explicit how Public Health Wales NHS Trust is seeking to expand its portfolio of work across the UK and internationally.
Aims: To present the work of Public Health Wales and the organisationís efforts to develop research capability and capacity to undertake public health research by collaborating with academic partners and other stakeholders and communicating findings.
D: Service Evaluation of R&D services within an acute NHS Organisation (no presenter – poster only)
A: Defining research responsibilities! A CTU and CRN interface agreement Sarah A Lawton, Senior Trials Manager, Keele Clinical Trials Unit Rhian Hughes, Primary Care Delivery Lead, National Institute for Health Research Clinical Research Network (CRN): West Midlands Jenny Stevens, Clinical Research Manager, CRN: West Midlands
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Directly Relevant to: Trial Managers, Study Coordinators, CRN Clinical Research Managers, CRN Research Facilitators
Objective/initiative: To outline the generic functions, communications, responsibilities and reporting arrangements between a CTU and CRN to support study development, feasibility, facilitation, set up and delivery, within appropriate governance and regulatory requirements.
Aims: It has become increasingly important to develop more formal procedures to identify the respective roles, responsibilities and functions provided by a Clinical Trials Unit (CTU) and NIHR Clinical Research Networks (CRNs) for those research projects eligible for adoption onto the NIHR research portfolio. The success of grant funding underpins the development of a CTU and successful study delivery maintains CRN infrastructure support. Early engagement assists study delivery to time and target.
B: A multi-disciplinary approach to risk management in clinical trials GCP Compliance Team, Joint R&D Office, Royal Marsden NHS Foundation Trust and Institute of Cancer Research
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Directly Relevant to: Senior R&D staff, any staff involved in quality assurance and risk management at all levels of seniority.
Objective/initiative: To demonstrate a strategy for achieving successful risk management for clinical trials in an NHS environment.
Aims: To show how risks can be efficiently identified and mitigated by creating an institutional culture of risk awareness involving multi-disciplinary staff groups
C: Developing research delivery competencies Helen Lewis, Research Matron, North Bristol NHS Trust Angelo Micciche, Research Infrastructure Manager, North Bristol NHS Trust
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Directly Relevant to: Research Infrastructure managers, Healthcare professionals responsible for the delivery of research projects, Research nurses preparing for NMC revalidation
Objective/initiative: Demonstrate why research delivery competencies were necessary; how they were developed, implemented and reviewed.
Aims: The implementation of a practice based competency framework to support the delivery of research within a NHS provider
D: Who audits the auditors: a risk-based approach for R&D oversight of research Lucy HH Parker, Head of Research Governance, St George’s University of London, Patricia Henley, Quality and Governance Manager, London School of Hygiene & Tropical Medicine
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Directly Relevant to: All R&D staff, particularly those who have been tasked with auditing and monitoring of studies
Objective/initiative: Provide an overview of the draft UK policy framework for health and social care research (draft released Feb 2015, with comments published Oct 2015), particularly with regards to any oversight requirements, including monitoring and auditing research projects. – Present different risk-based approaches R&D staff can take for oversight of projects at site. These include: audit programme, regular monitoring of high-risk projects, self-monitoring – Present results from a survey to R&D staff on their auditing and quality systems.
Aims: The aim of the session is to provide information and discuss the merits of a risk-based adaption programme for auditing within the R&D Department.