Annual Delivery Plan: 2017/18

Transcription

1 Clinical Research Network Yorkshire & Humber Annual Delivery Plan: 2017/18 Version: 1.0 Document date: 19th April 2017 Delivering research to make patients, and the NHS, better

2 Contents Glossary 2 Section 1: Compliance with the Department of Health / LCRN Host Organisation Agreement 3 Section 2: CRN High Level Objectives 4 Section 3: CRN Clinical Research Specialty Objectives 9 Section 4: LCRN Operating Framework Indicators 35 Section 5: NIHR CRN Priorities 2017/18 40 Section 6: Other local innovation and initiatives 43 Section 7: Financial Management 46 Section 8: LCRN Host Organisation Approval 48 Appendices 49 1

3 Glossary CDL CI CPMS CRNCC DH EOI HLO JDR LCRN LPMS LSL MHRA CTA NIHR PI PO PPIE PRA SSNAP SSS Y&H Clinical Divisional Leads Continuous Improvement Central Portfolio Management System Clinical Research Network Coordinating Centre Department of Health Expression of Interest High Level Objective Join Dementia Research Local Clinical Research Network Local Portfolio Management System Local Specialty Lead Medicines and Healthcare products Regulatory Agency Clinical Trial Authorisation National Institute of Health Research Principal Investigator Partner Organisation Patient and Public Involvement and Engagement Patient Research Ambassador Sentinel Stroke National Audit Programme Study Support Service Yorkshire and Humber 2

4 Section 1: Compliance with the Department of Health / LCRN Host Organisation Agreement 1.1. Please confirm that the Host Organisation will deliver the LCRN in full compliance with the DH/LCRN Host Organisation Agreement Terms and Conditions in 2017/18: Yes No X We will work with the newly appointed Non Executive Director to deliver on this. 1.2 If you have answered no to the above, provide a commentary below that highlights the specific clauses of concern and explain the reasons for potential non-compliance, and describes the actions being taken to address the concerns: 1.3. Please confirm that all LCRN Partner organisations will operate in full compliance with the CRN Performance and Operating Framework 2017/18 Yes No X 1.4 If you have answered no to the above, provide a commentary below that highlights the specific clauses of concern and explain the reasons for potential non-compliance, and describes the actions being taken to address the concerns: 3

5 Section 2: CRN High Level Objectives Table 1: HLO performance estimates Please complete Table 1, below, inserting the LCRN s estimated outturn performance for 2016/17 and the LCRN s estimated performance for 2017/18 and 2018/19. Objective Measure CRN National Target 2017/18 LCRN estimated outturn performance 2016/17 LCRN estimated performance in 2017/18 CRN National Target 2018/19 (Indicative) LCRN estimated performance 1 in 2018/19 1 Increase the number of participants recruited into NIHR CRN Portfolio studies Number of participants recruited in a reporting year into NIHR CRN Portfolio studies 650,000 65,000 (based on outstanding recruitment awaiting upload) 65,000 (10% of England Target) 650,000 65,000 (10% of England Target) 2 Increase the proportion of studies in the NIHR CRN Portfolio delivering to recruitment target and time A: Proportion of commercial contract studies achieving or surpassing their recruitment target during their planned recruitment period, at confirmed Network sites 80% 72% (ODP HLO Dashboard Month 11 Data-cut + ongoing review and analysis of open studies) 80% 80% 80% B: Proportion of non-commercial studies achieving or surpassing their recruitment target during their planned recruitment period 80% 76% (ODP HLO Dashboard Month 11 Data-cut) 80% 80% 80% 1 Note: the NIHR CRN High Level Objectives and/or targets may be subject to change following the DH annual review and approval processes for 2018/19. Please provide the LCRN s indicative planned contribution for 2018/19 against the indicative target for 2018/19. 4

6 3 Increase the number of commercial contract studies delivered through the NIHR CRN A: Number of new commercial contract studies entering the NIHR CRN Portfolio B: Number of new commercial contract studies entering the NIHR CRN Portfolio as a percentage of the total commercial MHRA CTA approvals for Phase II IV studies 675 N/A N/A 700 N/A 75% N/A N/A 75% N/A 4 Reduce the time taken for eligible studies to achieve set up in the NHS Proportion of eligible studies achieving NHS set up at all sites within 40 calendar days (from Date Site Selected to Date Site Confirmed ) 80% 74% (ODP HLO Dashboard Month 11 Data-cut) 80% 80% 80% 5 Reduce the time taken to recruit first participant into NIHR CRN Portfolio studies A: Proportion of commercial contract studies achieving first participant recruited within 30 days at confirmed Network sites (from Date Site Confirmed to Date First Participant Recruited ) 80% 0% (1 Study days - HLO Dashboard - Month 11 Data-cut ) 80% 80% 80% B: Proportion of non-commercial contract studies achieving first participant recruited within 30 days at confirmed Network sites (from Date Site Confirmed to Date First Participant Recruited ) 80% 100% (1 Study <=30 days - HLO Dashboard - Month 11 Data-cut) 80% 80% 80% 5

7 6 Increase NHS participation in NIHR CRN Portfolio studies A: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio studies 99% 100% ( HLO Dashboard - Month 11 Data-cut ) 100% 99% 100% B: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio commercial contract studies 70% 68% ( HLO Dashboard - Month 11 Data-cut ) 73% (16 of 22 partner organisations) 70% 73% (16 of 22 partner organisations) C: Proportion of General Medical Practices recruiting each year into NIHR CRN Portfolio studies 40% 50% ( HLO Dashboard - Month 11 Data-cut ) 45% 45% 45% 7 Increase the number of participants recruited into Dementias and Neurodegeneration (DeNDRoN) studies on the NIHR CRN Portfolio Number of participants recruited into Dementias and Neurodegeneration (DeNDRoN) studies on the NIHR CRN Portfolio 22, % (Portfolio ODP 4 April Data-cut) 2250 recruits, based on 10% of the national target 25, recruits, based on 10% of the national target 6

8 Table 2: Commentary on HLO estimates and improvement activities Please complete Table 2, below, to (a) provide a brief justification for the LCRN performance estimates for each HLO, and (b) briefly describe planned local activities and initiatives to improve HLO performance. HLO Justification Planned improvement activities Timescale (e.g Q1 or ) 1 Strengths across the network: 20 of our 30 specialties in the top 5 nationally Division 5 recruited 45% of our over all recruitment Significant commercial opportunities including med tech Robust community infrastructure embedded across Y&H 2 Work to raise awareness of RTT performance with partners and Specialties is ongoing. Remaining areas of underperformance addressed via escalations to the management team, support from Specialty Groups and the Study Support Service. Continue to build on 16/17 success and improvement of HLO 2a. Strategic use of cohort studies, data registries and informatics within the region to deliver high recruiting, population based studies of importance to our regional demographic. Use of infographics to recognise the disease prevalence across the region enabling research to be delivered where required. Identification of synergies across primary / community care and secondary care to optimise opportunities for patients to be involved in clinical studies involving many specialty areas - recently secured through specialty presentations at performance reviews. Building on examples where we have communities of consent. Address remaining areas not showing improvement, agreeing need for action with CDs, CDLs and Specialty Leads supported by action plans in place at a clinical level (i.e. feasibility, identifying where patient populations are based) and operational level. Performance management - collaboration between Industry Lead and Specialty Leads. Intensive focus on excellence of commercial study set up during 17/18, driving completeness of EDGE data to expose patterns of lost recruitment windows due to set-up delays, will enable management of HLO4 and HLO5A as well as driving further improvements HLO 2a. Robust feasibility, site selection and site support via Trust based delivery staff. 7

9 Engagement with DGHs to continue and focus on developing skills of those who in previous years were greenshoot sites. Enhanced performance management processes utilising skills within both SSS and Trust based staff. All initiatives to be measurable and demonstrate impact. (i.e. Specialty Lead support plan to enhance Clinician engagement). 3 N/A Continue to promote life sciences research to all partners, presenting at Research Nurse Meetings, Research Celebration events etc. 4 There has been variability for this metric, we need to ensure consistency across setup times and study start-up. 5 5b. Non-commercial first participant recruited need to show sustained improvement in 17/18 Work with new and established Primary Care clusters to promote the value of industry research, providing intensive support in EOI completion, site selection and delivery of first commercial studies. Build on success with local wound care company, suggesting local sites through new nurse CI. Explore opportunities to support local devices used in clinical practice and investigations, working with HTCs, DECs and CTRUs to offer rapid assessment of devices. Collaborate with other Northern LCRNs under the NHSA banner to streamline processes in chosen Specialties, starting with Gastroenterology. Over 2017/18 YH CRN will continue to support partners to ensure EDGE data is up to date which will support the reporting and management of HLO4. Our SSS team will use trigger points during the setup process to prompt for data completion in EDGE. We will begin a process of reporting HLO 4 data to Trusts and will work closely with partners who are not meeting the HLO requirements to provide support and expertise to help Partner organisations meet the required benchmark. Emphasise the importance of this metric with partners and study teams. Identify those specialty areas where this works well and interrogate how this is achieved to enable sharing of good practice. 8

10 Consider how we can use databases and informatics to improve this metric. 6 6A: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio studies 6B: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio commercial contract studies 6C: Proportion of General Medical Practices recruiting each year into NIHR CRN Portfolio studies 6A = 22/22 (100%) 6B = 15/22 (68%) 6C = 372/749 (50%) (Data taken from ODP-HLO Dashboard (27 March 2017 data-cut April to February) 7 Deliver 10% of the national target Ensure we engage early with regional CIs and academic institutions Timely information and dissemination about all new studies Utilise informatics to place studies where the populations are based eg. HES data Work with Research Ambassadors to raise JDR in their organisations Ensure we broaden the reach to allow patients opportunity to be involved in studies Take advantage of cohorts and communities of patients who have consented to be approached Section 3: CRN Clinical Research Specialty Objectives 3.1. List your priority investments to support CRN Specialties in the development and delivery of their 2017/18 Objectives The Network has strong specialty and divisional clinical leadership. In February, the leadership team held individual meetings for each specialty lead, reviewed performance with the specialty leads and planned future strategy. These discussions informed planning for 2017/18. The CRN Y&H has considerable strengths in primary and community care using an effective and successful cluster model for research active primary care practices. During the coming business year we will further align community and secondary care research infrastructure in the region to enable and drive studies that follow patients across the whole journey of their care. Yorkshire Cancer Research have funded a number of large studies set partially or wholly community and primary care which has provided an opportunity to support an integrated approach to patient recruitment and study management in this specialty we will be holding a themed meeting bringing together leaders from cancer and primary care research in June of this year to support the roll-out of the studies and to discuss the opportunities and challenges for seamless study management across different healthcare sectors in the region. This will be an 9

11 exemplar for other themed meetings such as that in public health discussed below. The CRN supports a number of research nurse cohorts which are already effective in research recruitment. During the coming year cross sector working will be a particular focus for this group of colleagues. During the coming year we will build on our strength public health to identify and support research in the most at need populations in our region. We will hold a public health themed meet working with the public health leads in the region and engaging our Partnership Group, R&D Directors forum, Commissioners, and Universities to identify conditions and groups in the region where there is an unmet need or access to high-quality clinical studies. This will inform our use of resources including both the allocation of contingency funding and cohort research staff. Also help identify specialties where there is a particular need to drive engagement with Higher Educational Institutions in the region to support the study pipeline going forward. We will grow our community of principal investigators by investing 10% of our contingency funding in "green shoots" development of new PIs. We will particular target areas of need identified by our public health initiative and we will drive partner engagement by using a matched funding approach. The CRN Y&H supports a strong community of Allied Health Professional investigators and we will target a proportion of our "green shoots" funding to support the further development of this group. We will continue our already successful work with trainee research networks, developing a strategic approach with the Yorkshire and Humber Deanery. We will ensure the stability and continuity of the strong paramedic workforce that has developed within the Yorkshire Ambulance Service as a result of the AIRWAYS2 study by integrating this group with our Injuries and Emergencies research infrastructure and funding paramedic research attachments. We will continue with current work developing an integrated structure to deliver commercial research in gastroenterology across the four CRN's in the North of England and apply the lessons from this work to other specialties. We will build on our already considerable strength in PPI with an initiative for patient and public engagement with children and young people's research modelled on the successful approach of our oral and dental specialty group using schools networks to engage children and young people. Specialty strengths will continue to be supported to deliver national objectives as described in Table 3 below whilst driving an overarching strategy of integrated working across sectors, developing new investigators, and increasing patient and public involvement Describe how you will ensure that LCRN Local Clinical Research Specialty Leads work effectively locally and with the National Clinical Research Specialty Leads In order to support Specialty Leads and drive the clinical research agenda, the network has identified and operationalised key support activities required to assist Specialty Leads in forging and maintaining collaborative clinical partnerships across the Yorkshire and Humber geography and with National Specialty Leads. A thematic approach to support specialty leads will continue to be endorsed by CRN Y&H to enable sharing of best practice, identify opportunities for cross cutting studies, build capacity and drive performance. In 2017/18 CRN Y&H will work with research teams across the network to develop key resources to further promote local engagement, including development of regional portfolio maps and specialty information matrices. Three areas of specialty activity have been identified which require consistent support from the network to enable Specialty Leads to influence across organisational boundaries and support equitable access for patients to studies. Support activities 10

12 relating to the three areas are outlined in appendix 2 ; these embrace a) Attendance and Engagement with National Specialty Groups, b) Regional Specialty Meetings and c) Teleconferences, Business Meetings and Specialty Performance Review Please complete Table 3 with details of local plans to contribute to achievement of the 2017/18 Specialty Objectives, giving quantitative information where possible Table 3: Local contribution to national Clinical Research Specialty Objectives # Specialty Objective Opportunities/Challenges Local contribution and plans to support the objective and grow the Specialty in 2017/18 Timescale 1 Ageing Each LCRN to have an Ageing Local Specialty Lead who demonstrates leadership in their region and can provide examples of leadership of initiatives aimed at increasing recruitment and research capacity in their regions Opportunities Close collaboration with Academic Departments in Bradford and Leeds developing and delivering NIHR funded studies has resulted in Y&H Age and Aging being a top recruiting specialty nationally. Discussions with the national lead about appointing a senior nursing lead or cross network leadership are under consideration. Challenges Unable to secure a Specialty Lead in Age and Aging for Y&H, to date this has been addressed by Chris Oxnard and Chris Rhymes who have provided close support for this specialty. Plan Support themed meeting for Ageing, to include Oral and Dental, MSK, Wound Care, AHPs, Stroke and Parkinson s Disease Work with nurse specialists and practitioners to grow PI pool Engage with the Yorkshire and Humber British Geriatrics Society to work with their network to promote age ageing research. Identify Nurse consultants in speciality to support leadership and engage with clinical research agenda In pipeline: I&E - Elderly frailty and prevent admissions - YAS Pre and post op Anaesthesia Electronic Frailty index - Andrew Clegg Speech and Language therapy/ centre for Ageing STH Elderly care physicians Stroke 11

13 2 Anaesthesia, perioperative medicine and pain management Establish links with the Royal College of Anaesthetists Specialist Registrar networks to encourage and support their involvement in recruitment into NIHR CRN Portfolio studies Opportunities The lead for RAFT is now a member of the Specialty Group and a significant proportion of national meetings are taken up with matters pertaining to increasing trainee engagement. Trainee network has already contributed to an observational project therefore links are already in existence. Plan Work with Specialty Leadership to continue to promote trainee engagement within the NIHR. Strengthen the relationship between the network and local deanery through the Specialty Training Committee - presentations via regional training programmes. Promote the involvement of trainees network with existing and potential new Y&H Chief Investigators. Recognise the input of trainees more formally through letters of recognition, funding of meetings, websites and assistance with mentoring. Q1-3 Q1 Identify pipeline studies which are suitable for trainees to support e.g. EPICCS. Support regional involvement with large national outcome studies from the Royal College of Anaesthetists Health Services Research Centre e.g. SNAP2. Q1-2 Build on local strength and leadership in perioperative medicine research to support roll out of studies across the region. 3 Cancer Increase patient access to Cancer research studies across the breadth of the Cancer subspecialties Opportunities National and regional priorities in both service and research networks to promote work in screening, early diagnosis and living with and beyond cancers. These are new areas of opportunity for research. Plan Work with partner organisations and investigators across the region to promote a balanced portfolio of interventional and observational, academic and commercial studies in cancer to ensure that patients are able to access relevant studies wherever they are receiving their cancer care. Recent funding from Yorkshire Cancer Research to support a number of large studies in screening and early diagnosis in the region. Support collaborative working with colleagues in primary care to ensure optimal delivery of recently funded studies. In particular a joint cancer and primary care meeting has been arranged in June 12

14 Collaborative working with colleagues in primary care, community/hospices to support delivery of these studies. A number of high profile leaders of cancer surgical research in the region capable of driving forward surgical trial recruitment Cross specialty working eg. surgery, gastro, respiratory, dermatology Plan for Teenage and Young Adults and paediatrics sitting in secondary care. Challenges Precision medicine leading to trials suitable for ever smaller sub-populations of patients, necessitating large numbers of trials to be open, often with low single figure targets. The patient care pathways are changing with a focus on community, care at home and primary care Heavy burden of follow up from trials that recruited >5-10 years ago. Legacy funding across the network suggests existing distribution of funding does not support optimal delivery of current portfolio priorities. Cancer workforce pressures reducing 2017 to promote the new studies and discuss how they can best be delivered. Work with specialty and subspecialty leads to undertake a review delivery infrastructure, funding and capacity across the cancer division to ensure that resources are being used most effectively to support current priorities, future study opportunities and population needs. Sub-specialty Leads to advise colleagues of potential new studies and to actively monitor specialty related study performance. We will continue to work with subspecialty leads to horizon scan for new studies and to seek opportunities for cross referral around the region where it is not possible to open studies in every centre. We will continue to work with local funders (in particular Yorkshire Cancer Research) and investigators to support the development and delivery of new studies. Q1-2 13

15 time available to support and promote research. 4 Cardiovascular disease Improve patient access to Cardiovascular Disease studies on the NIHR CRN Portfolio Opportunities Yorkshire and Humber have traditionally led the way on Cardiovascular research. This is because we have a wide range of research active sites and we have Chief Investigators in several of our sites who are able to run large, multi-centre research alongside more small scale, leading edge research. luk GRACE Risk Score, which is currently in setup. Challenges We will have had fewer large-scale studies led from our region in the last year. Plan Work with our colleagues across the region to open more sites in multi-centre research. Continue to build on community collaborations, opportunities and success. Review of our specialty leadership and improve engagement with the national group. Early engagement and support for CIs currently submitting research proposals e.g. BHF application. Development of CVD patient interface to enhance take up and adherence to cardiac rehabilitation and prevention programmes relating to research. Q1-3 5 Children Increase NHS participation in Children's studies on the NIHR CRN Portfolio Opportunities The development of Children s CRFs in both Leeds and Sheffield will enhance the region's ability to respond to EOIs for specialised clinical trials. Increased clinical engagement within the DGHs provides greater opportunities for children and young people to participate in research. Plan Continued support of CAMHs studies. PPI plans re the development of a Children s and Young People working group to support the activities of local groups in Y&H. Development of Partnerships with those in the DGHs - providing general support alongside undertaking horizon-scanning to ensure selection for suitable studies. Q1 Q2 14

16 National Lead also is also the Division 3 CDL. Challenges A main, and continuing, challenge is the lack of suitable studies available for DGHs. Although Industry studies are increasingly offered to those sites that have had previous success it remains a challenge to convince Industry partners of the skills within the smaller units. Staff retention - this is of concern as there are an increasing number of vacancies as experienced delivery staff leave for posts that offer permanency and development opportunities not recognised within many of the sites currently. One of the key areas that the D3 Clinical Divisional Lead is working on is the development of an innovation to support the research pipeline to ensure facilitating the evaluation of devices exiting the innovation pipeline. This work is supported by both the NHSA and AHSN communities. The CRN-Children are working with the Business Development Unit to identify studies in development to ensure that studies come to the UK. It is important in Y&H that we make sure that we identify key staff who may be able to support these studies if the UK is chosen as a global recruiting centre. To improve staff retention - work with Trusts to ensure suitable contracts (SCH have already commenced offering permanent contracts to all Paediatric trained research nurses and demonstrated increased responses to Job adverts and sustainable teams) Q1 Q1-2 Continue Cluster Model of leadership and team days. 6 Critical care Increase intensive care units participation in NIHR CRN Portfolio studies Opportunities AIRWAYS 2 has increased awareness and engagement in research within both clinical and nursing teams and we will maximise this engagement, exploring opportunities to realise capacity in standard clinical care staff to deliver elements of patient recruitment using a similar model as that developed in I&E Plan We will support the proposed move to a shared leadership model in Yorkshire and Humber critical care specialty group proposed by clinicians in this group. This better supports engagement with clinicians across the whole region. We will support the current discussions between of clinical leaders in the region with the National Specialty Lead for Critical Care. Professor Paul Q1-2 Q1 15

17 and IBD/gastro. Emergence of strong new leadership in critical care research in a large teaching hospital in the region engaging with both the CRN and national specialty leadership. Challenges The requirement for Specialist ICU nursing support for research can limit capacity at department/trust level. Potential lack of support for PI/CI in POs in the research agenda resulting in limited opportunities to grow the portfolio. Variable engagement with critical care research across the region despite the presence of a number of large teaching hospitals with large intensive care units. Dark to identify and support critical care studies to be delivered in Yorkshire and Humber. We will support a regional meeting planned as part of this initiative. Our lead nursing team will continue to grow links with clinical staff to build sustainable options for recruitment, identify critical care study opportunities and available clinical workforce to support research activities using a named nurse system. Guidance and input available through network early contact and engagement offer will support further growth and the development in PI & CI interest. Continue leadership collaboration with linked specialties to enhance opportunities for research across specialties and allow specialist registrar networks to support peri-operative research care pathways and specialist surgical endeavours (bariatric/obstetric surgery) mapped to patient pathway. Q1-2 We will support critical care engagement with region trainee research networks in anaesthesia, perioperative medicine and critical care (AARMY and SHARC) to support both recruitment and the identification and development of local investigators. 7 Dementias and neurodegeneratio n (DeNDRoN) Optimise the use of Join Dementia Research to support recruitment into Dementia studies on Opportunities Changing clinical and care pathways provide new opportunities to deliver JDR and dementia research in collaboration across different interfaces and Plan Build on work with NHS England Y&H Dementia Clinical Network to promote JDR across the region. 16

18 the NIHR CRN Portfolio stakeholders. Greater opportunity to work with memory clinics across Y&H. High priority health care need makes dementia and neurodegenerative disease like Parkinson s very visible to the public. Challenges Not fully optimising use of JDR to support researchers with recruitment. Promote JDR in local pharmacies; working with Mahendra Patel Continue the promotion of JDR in local trusts utilising Patient Research Ambassadors to promote awareness Work with charities to promote public awareness Continue to support researchers to add their studies to JDR. Make JDR a network priority across all specialities Identify the successes of trusts and utilise this Work closely with Admiral nurse to understand their interest in being involved in research and then support the development of their roles. Enthuse new researchers including PIs through roadshows - evidenced by engagement of 5 new PIs and new PIC sites in 17/18 Build regional CI research strengths to encourage regional studies for regional delivery Facilitate more involvement of PhD students Continue to showcase positive results and successful collaborations to encourage research to be delivered in the region Identify opportunities through established posts and services dementia nurses and memory clinics Grow regional PIs - engagement event with 17

19 national CIs sharing their studies. 8 Dermatology Develop the Dermatology Principal Investigator (PI) workforce Opportunities Expanding AHPs in the specialty GPwSI and nurse prescribers / consultants. Active nursing infrastructure Active trainee forum through the Centre for Evidence Based Dermatology Challenges Paucity of PIs, significant number of national vacancies and high number of specialist nurses due to retire, Plan Plan to develop nursing PIs; Through British Dermatology Nursing Group (BDNG) as subgroup of nurses with an interest in biologics who could be supported to be PIs for BADBIR the biologic register. Working with Professor Ersser nursing professor in Dermatology at York University to identify opportunities to develop nursing PIs. Working with private providers. Opportunity to work with private providers and to identify a potential PI working for Virgin who is keen to engage with dermatology research and develop PIs. Q1-2 Commercial opportunities: Looking to build on commercial strength of treating children with severe atopic eczema with biologics. Prof Cork recruiting patients from all over the UK - realised targets by adopting this centralised approach making it attractive to pharma when looking to support centres to do these competitive studies. Working with another paediatric dermatologist in Y&H to enable another experienced site to open. (Potential PI in Leeds). Q1-3 Trainee development: Continue to collaborate with the Centre of Evidence Based Dermatology who have 18

20 supported a trainee research network; we will encourage local trainees to develop research skills to enhance delivery through this supportive environment. Work with the deanery to embed research delivery as part of the training curriculum. 9 Diabetes Increase primary care recruitment into Diabetes led and supported studies on the NIHR CRN Portfolio Opportunity We have strong support from clinicians in primary and secondary care to meet this objective. Infrastructure to support diabetes has been established and extended in primary care over the last 12 months - this larger network can now be utilised to realise better engagement with primary care. A recent themed meeting for Diabetes and Obesity highlighted positive ways of working that would enhance diabetes research in the community. Plan A recently established Diabetes Learning Community which facilitates working of research nurses across the region (see Section 6) will enable the delivery of diabetes studies in primary care. Regular meetings will support collaborative working across primary and secondary care interfaces. Our Study Support Service team is looking at opportunities to deliver research in primary care. We are working with our specialty leads to see if some of the studies they have run on a small scale locally, could be expanded across the network. Challenge The need to align diabetes studies to our regional demographic. We will establish a visible network of expertise across secondary and primary care a Y&H "research identity" Identify a Nurse champion and Primary care steering group lead to support diabetes in PC Q1 Collaborate regionally on grant applications to ensure strengths of the region are recognised Align with the regional Y&H GP steering group to improve delivery across care pathways and Q1 19

21 engagement with high profile national studies 10 Ear, Nose and Throat Develop research infrastructure (including staff capacity) in the NHS to support clinical research Opportunities Build links to other specialties in order to maximise the use of research infrastructure and staff capacity in other areas including respiratory, head and neck/maxfax surgery, injuries and emergencies and children's specialties. Explore opportunities to build research capacity in other NHS services including Hearing aid clinics, high street hearing test centres and AHP link eg. occupational therapy and speech therapy Plan Review portfolio and encourage trainees in engaging with research studies, including collaborations with respiratory and children s specialties. Provide support and guidance via SSS/Lead Nurse to identify key opportunities to widen the resource and workforce available to support ENT studies. Develop thematic specialty meetings to identify and strengthen clinical alliance across specialties and sharing of infrastructure. Q1-2 Q2-4 Challenges Limited portfolio of studies available Review current ENT research provision across the region. Q1-2 Link with public health, primary care and AHP specialties to develop routes into NHS services to offer research opportunities. 11 Gastroenterology Increase the number of patients recruited into Gastroenterology studies on the NIHR CRN Portfolio Challenges Maintain interest and engagement within all trusts against difficult clinical climate. Opportunities All acute Trusts within region participate in gastroenterology studies. Utilise this engagement to build infrastructure and realise further growth within DGH s to widen the population reach for gastroenterology studies. Effective joint leadership that encompasses the region, plays to local strengths, and benefits from the national Plan Continue to engage local staff with the regional LCRN concept through continued programme of engagement and active communication. Strong local clinical leadership established in acute Trusts in 16/17 will continue to be supported with regular t/con input and communication with regional specialty leads. Use of the regional leadership group to review EOI/feasibility/site identification. Continue our close collaboration with local CTRU s to grow and develop researchers within region. Continue to develop and evaluate the CTRU NIHR Q1-2 20

22 leadership role of one of the two local leads. drop in clinic which is being piloted at Leeds University. Gastroenterology has a strong commercial portfolio and a regional approach to establishing interest and delivering against time and target. Support further work with endoscopy, IBD and oncology as specialist areas with links to the gastroenterology portfolio. The specialty has an established standard clinical nursing model that provides direct research support for patients and creates capacity. Collaborative community across the CRN and IBD leads at all sites. 12 Genetics Increase early career researcher involvement in NIHR CRN Portfolio research Opportunities To encourage the increased number of Clinicians being engaged in research in this area the Specialty Lead will aim to identify possible Early Career researchers by engaging with Deanery Educational Advisors, local HEIs to raise awareness of research as a career opportunity. Successful year on year growth will provide a sound CV to offer to the Life Science sector. Challenges Achieving RTT regularly is dependant on patients with Rare Diseases being identified and invited to participate. Maintaining the development of the Rare Diseases Facilitator role is important in order to sustain the growth locally in this Plan Support Early Career Researcher once in role. Collaborate with the Genetics Medicine Centres (GMCs) and Division 1 Delivery teams to support recruitment to the 100K Project. Building on the 100k Genome CRN/GMC relationship it is planned, in partnership with the AHSN, to develop a regional strategy for the development of Genomics research activity. This will be aligned to national priorities and local population healthcare requirements. We have already commenced a cross-network dialogue with East Midlands and will move forward with their support. Alongside encouraging the limited number of available commercial studies to consider Y&H as a site the genetics team are also focussing on increasing the number of Biomarker studies which offer treatment/diagnosis pathways for the patients Q1 Q1 Q2 21

23 area. (participation in CLARITY-HD is starting point for this plan) Continue to support patient opportunity to participate in Rare Disease Studies via Rare Disease Register. (UKRGDRC) Q1 13 Haematology Establish links with the relevant Royal College or national society to encourage and support trainee involvement in NIHR CRN Portfolio studies Opportunities As the number of studies being offered to Y&H has maintained its growth there is an opportunity to identify early career researchers. There is increasingly opportunities to work with the Life Science Industry. Challenges Increasingly the main challenge in Y&H in this clinical area is the constant need to be working clinically rather than in the research area due to staff shortages. 2016/17 has been particularly challenging for this reason. Plan To continue support of the Specialty Lead and the identified trainees who will support specifically identified Studies. To ensure support when/if required re Staff Capacity. To support sound feasibility, realistic target setting and robust EOIs to promote selection of appropriate sites. The low numbers of studies currently opening impacts on maintaining growth in the number of patients participating - a challenge will be to attract new studies, especially due to capacity concerns. 14 Health services research Develop research infrastructure (including staff capacity) in the NHS to support clinical research in Health Services Research Opportunities Working with our HSR researchers in developing their portfolio. Ensuring high quality delivery of HSR research across Y&H. Work with community partners - Local Plan Continue to work closely with NIHR partner CLAHRC with aim of:- Increasing the number of PIs in NMAHPs through ACORN (Addressing Capacity in Organisations for Research Network) with emphasis on HSR 22

24 Authorities, identify community workforce and other non NHS settings for the delivery of portfolio. Exploring the positive impact of research in NHS organisations to encourage further engagement. Developing new pathways for delivery of support outside the NHS e.g Yorkshire Health Study and E-SEE project Exploring the positive impact of research in NHS organisations to encourage further engagement Develop governance processes when delivering research in non NHS sites Work with the team in Bradford developing the new Wolfson Centre for Applied Healthcare Research Close collaboration with the CIs/PIs across the network. Utilising the flexible research delivery workforce to support their portfolio. Work with Health visitor and school nurse groups locally to engage in clinical research 15 Hepatology Increase access for patients to Hepatology studies on the NIHR CRN Portfolio Opportunities The next commercial studies to become available are in autoimmune liver diseases where South Yorkshire is particularly strong. New link with Leeds Carnegie University in the field of exercise and liver disease being developed. Challenges Expect a lower number of patients in 17/18 as sites have recruited to existing large cohort studies. HCV study numbers likely to decline due Plan There are particular strengths in different aspects of hepatology research in the different parts of the region: viral hepatitis in West Yorkshire, NAFLD in Humber and autoimmune disease in South Yorkshire. We will take advantage of and support this varied expertise by supporting the plans of the specialty leads to extend recruitment into studies in each of these disease from the areas across the region, do increasing both recruitment and access to research. Review nursing support across region to ensure access is available for patients at all sites across the regions - review possible collaboration with gastroenterology specialty to increase regional Q1-2 Q1 23

25 to successful oral therapy becoming generally available. workforce capacity. Support local site uptake of NAFLD and autoimmune liver disease studies through increased communication and dissemination of portfolio study information at Specialty meetings and through engagement of Specialty Leads. 16 Infection Increase participation in Infection studies on the NIHR CRN Portfolio Opportunities Cross-specialty working with injuries and emergencies, ICU and microbiology. Realise recruitment from AQP patient populations. Challenges Changes in specialty leadership require re-engagement with specialty leadership, and delivery staff to develop strategic vision. AQP research governance issues prevent patient participation in some areas across the region. There has been a recent change in specialty leadership with two of the three current leads stepping down because of their changing roles. Plan Support the network Senior Research Nurse to work closely with the specialty lead to develop a regional strategic vision for infection. Establish clinical leadership links in south and the north of the region to ensure new CIs and PIs are supported. Increase patient recruitment in antimicrobial resistance and sexual health studies through supporting different ways of working (e.g. flexible use of staff, out of hours care). Provide a balanced portfolio for both GU Med and infection through clinical and SSS support. Where research governance issues relating to AQP s (Locala in region) continue to prevent studies opening, work with the relevant research management teams to unblock study setup. We will support the current lead, who is also National Specialty Lead to maintain engagement with the clinical community following the recent specialty leadership changes. Q1 We will support the specialty lead in identifying colleagues to support research in subspecialties within infection such as virology. Q1-2 24

26 17 Injuries and emergencies Increase participation in pre-hospital studies via Ambulance Trusts Opportunities Existing partnership with Yorkshire Ambulance Service through participation in hugely successful AIRWAYS-2 study. We have managed to raise the potential of I&E research across Y&H despite service pressures and A&E department closures. Plan Continue to promote The Big Front Door initiative and identify new pre-hospital studies suitable Yorkshire Ambulance Service. Encourage and support the attendance of Representatives from the Yorkshire Ambulance Service Trust at our regional meetings. Growing strong engagement in the research agenda across the region, specialty group is supporting the development of regionally developed studies which can be supported by paramedic researchers and have potential to prevent admission. Challenges Funding the research paramedic roles (YAS) when the portfolio is fallow. Create links to trauma via national specialty group and surgical specialists. Develop of Y&H CI-led studies where recruitment takes places out of hospital utilising paramedic research ready community. Continue cross specialty working to further develop - stroke (RIGHT2) and ENT (epistaxis). Continue growth in diversity of local specialty group which now has representation from RDS, The CURE collaborative, YAS and commissioning services. Q1-2 Q1-2 Review recruitment per incidence of ambulance use. Q1 Consider novel deployment of research paramedics to clinical areas where their skills can be used if I&E portfolio is fallow. 18 Mental health Increase participation in Mental Health studies involving children and young people Opportunities Actively look for studies involving children and young people. Increase research capacity of CAMHS teams. Utilise CAMHS Research Champions Plan Increase number of PIs participating in studies involving children and young people. Utilise PPI groups focusing on mental health in young people (Young Dynamos). Support Research Champions in implementing the 25

27 PPI agenda. NIHR strategy for CAMHS, mobilising CAMHS community and increasing number of the service related studies. Organise a CAMHS research related study day. Collaborative working with CLAHRC and mental health trusts to demonstrate what the CRN Y&H have to offer through a dedicated communication. Q1-3 A recent James Lind Alliance on Bipolar disorder led by a local CI offers an opportunity to lead some research within this specialty area in our region. Working with NHS England Y&H Mental Health Clinical Network to highlight and promote studies. Utilise the Y&H 0-19 network to promote and deliver mental health studies to young people across the network. 19 Metabolic and endocrine disorders Increase participation in studies on the NIHR CRN Portfolio relating to areas defined to be of national priority Opportunities Our region is one of the leaders in Metabolic and Endocrine disorders research. One of our particular Strengths is that we have two specialty Leeds who work very effectively together, but who also develop portfolio research that can be delivered across the region. Plan The relatively low numbers of studies and participants, means that our best opportunity to develop this area is to support our CIs who are developing portfolio research. We do this through regular meetings and by ensuring they have good access to all of our Study Support Service. 20 Musculoskeletal disorders Increase engagement of orthopaedic champions to support the delivery of Musculoskeletal Disorders studies on the NIHR CRN Opportunities Build on our orthopaedic portfolio expertise in the network. Plan Work with our current leads in orthopaedic research leads and showcase their work through specialty work and communications. Work with our flexible workforce and partner organisations to support new principal investigators. 26

28 Portfolio Novel directorate change in STHT lends itself well to potential synergies between MSK and other specialties (chronic pain, hand clinic, metabolic bone diseases, MSK therapy services, orthopaedics, rheumatology). Plan a themed meeting to enable collaborations across the region. 21 Neurological disorders Increase the level of early career researcher involvement in NIHR CRN Portfolio research Opportunities Promote research within the junior doctors community. Include junior doctors on study delegation lists if appropriate. Plan Organise New PI training days. Organise GCP training for junior doctors Consider appointing a joint research fellowship post shared with Stanford University USA - green shoot opportunity. Implement some research roadshows across Y&H to explore barriers to conducting research and training requirements Novel commercial opportunities through direct engagement with Pharma and evidence of recruitment to time and target. New partners include Bial, LivaNova, Lilly Q1 Q1 Q1-2 New studies with current collaborators LCG - epilepsy, GW Pharma. Build on hub and spoke approach creating cohesion between larger teaching hospitals and smaller district partners. Roadshows to target hospitals where study participation is low to explore barriers to participation, staff and educational needs. Strategic investment to enhance recruitment capacity e.g. a) Securing support for a time for a 27

29 physiologist; b) Improved integration of specialist nursing and research nurse services Mentoring excellent examples of mentoring junior staff in specialist areas of MS and Epilepsy. 22 Ophthalmology Increase NHS participation in Ophthalmology studies on the NIHR CRN Portfolio Opportunities BEAP- large recruiting study in region Strong clinical engagement and CIs Route into Royal College of Ophthalmology Challenges Lack of medical illustration and optometry support in several local Trusts. Plan Expand activity to other areas of service e.g. non-retinal studies through locally initiated large scale portfolio studies. Support the creation of a local, trainee research network and the trainee co-pi network to strengthen links with trainee networks. Build capacity for trainee support of portfolio studies and trainee-initiated projects in the future. Q1-2 Survey of local PIs to identify barriers to recruitment has been completed - need to respond to the opportunities and challenges identified. Q1-2 Review optometry and medical illustration support to assess ability to support an increase in activity. We will support the specialty leads in engaging with optometry training in the region to engage this group of AHPs with research early in their careers. Build further links to specialist nurse and optometry support via such groups as the Yorkshire Retinal Society. Expand industry collaborations including horizon scanning of new studies with Bayer/Novartis. 23 Oral and dental health To increase research awareness in the dental community and Opportunities Supporting Primary Care Dental Practices. Mixed models of research delivery. Plan Working with NHS England to support research governance and delivery in Primary care dental practices. Q1-2 28

30 increase the research-trained workforce Utilising school nurses to deliver dental research in schools in the region. Use of cohort and community research nurses to support delivery and provide formal and informal training. Aim to enhance delivery by enabling growth through increased capability, capacity and activity through working with established infrastructures to do this e.g. SMILE AIDER - successful PPI forum - very engaged consumers - will work with this group to inform research at every level and adopt and assess the impact of research that addresses oral health challenges with feedback of outcomes DENTPRIME NORTHERN - dental primary care northern oral health research network Schools - RAISED in YORKSHIRE (Research activity in schools evaluating dental health) - we will support growth of the schools network. Care Home Network NIHR-CRF - translational research Will encourage and implement the national online GCP programme for dentists in Y&H aim to secure 17 new trained staff through engagement with Deans of Dental Schools, Primary Care Network members and Y&H deanery. In order to increase opportunities for the public to be involved in research across Y&H will engage nationally and aim to: Align research delivery in the future to the James Alliance priority setting partnership which aims to focus on children and young people, adults as well 29

31 as people requiring special care and older people. Encourage national collaboration with cross specialty working e.g workshop on developing NIHR grant on oral health and comorbidity - periodontal health and diabetes (with heart disease) Respond collaboratively to NIHR commissioned calls. 24 Primary care Increase engagement of GP registrars and First Five GPs with NIHR CRN Portfolio research Opportunities Promotion of the NIHR and NIHR research portfolio amongst GP registrars. Plan Working with our cluster leads to support GP registrars undertaking portfolio research. Network attendance at the 2017 NIHR Academic Clinical Fellowship meeting. Delivering workshop on NIHR support. Q1-2 Working with the three new professors of primary care in the region. Engage with GP training programmes through the deanery and trainees to increase the visibility of the NIHR and embed research delivery as part of every-day practice. 25 Public health Develop research infrastructure (including staff capacity and working with local authorities) to support research in Public Health Opportunities Continued NIHR support of the Local Authority research Champions through (LARK) Utilisation of established cohort study activity & promotion of the Y&H broad demographic and significant diversity in health needs and inequities across the region. Plan Development and utilisation of Y&H 0-19 network fledgling network of school nurses and health visitors interested in developing a portfolio of studies in Y&H. Both NHS and 3rd Sector school nurses involved. Continued support of our YH CI lead cohort studies and develop new recruitment strategies utilising social media and the 3rd sector. Development of stakeholder Promote research platforms/cohorts (e.g. 30

32 relationships New NIHR CRN Eligibility criteria can promote portfolio inclusion for PPH research Yorkshire Health Study, BiB) as potential study populations/sites Establish local links with PHE and ADPH in the Y&H region. Challenges Identifying synergies with Local Authorities. Organisation of meetings to promote engagement with the public health workforce and raise the profile of the PH portfolio Q1-2 Identifying new pathways for delivering support outside the NHS. Facilitate portfolio inclusion for studies in non-health settings (i.e. that do not require HRA approval) Securing appropriate resource to recruit to large studies. Further develop the LARK e.g. Local Authority Research link (LARK) with the aim of one champion in each of our local authorities. Strengthen relationships with ADPH and DPHs Promote exemplar studies that have established support pathways outside the NHS Work with local authorities to develop mechanisms for delivering CRN support within a local government environment Work with the team in Bradford to support the developing Wolfson Centre for Applied Healthcare Research. 26 Renal disorders Increase the number of 'new' Principal Investigators (PIs) engaged in commercial Renal Disorders studies on the NIHR CRN Portfolio Opportunities We have a strong clinical leadership in renal research, with three speciality leads representing the three renal units in the region providing support to their peers in local hospitals. We already have pure renal research going in in many of the main hospitals where it could be done, but we will try to involve a broader Plan Our aim in Renal research is to build on our strengths. That is, to continue to support our specialty leads in their roles as leaders and mentors, but also as a source of new research. We feel we can do this better with a coordinated set of meetings across the region to bring teams together. Q1-3 31

33 range of PIs. MRC partnership biobank. Challenges Renal research is conducted in all main hospitals where it could be done, but there are a paucity of PIs. One of our best opportunities to broaden PI engagement is to work with our newest Renal CI; Beverly Snaith from Mid Yorkshire Hospitals NHS Foundation Trust. Her new study SCIPS Streamlining Cross-Sectional Imaging pathways has the potential to introduce a new type of PI to Renal research across the region. We will also continue to support the team behind SCIPS as they seek to turn their excellent research into something multi-centre. There is potential opportunity to engage some new PIs with the advent of some new consultant appointments within the region. PPI engagement to help to drive interest in renal research will be support though Point of science - clinicians presenting in layman's terms to the public usually out of traditional NHS settings. 27 Reproductive health and childbirth Increase the proportion of NHS Trusts recruiting into Reproductive Health and Childbirth studies on the NIHR CRN Portfolio Opportunities Raised awareness of Reproductive Health & Childbirth (RH&C) activity in DGHs, currently we are aware of suitable studies for the patient population. Maintaining activity will stabilise the RH&C workforce within the RH&C setting and enable a raising awareness of the achievements of this Specialty area (currently Lead Specialty nationally and, locally, persistently in the top 5 recruiting Specialty in Trusts) Plan Identify lead Midwife/Nurses in POs to support recruitment which brings opportunities to participate in more complex studies. Plan a themed meeting in RH&C to include other related specialities. To continue developing partnership activity through study specific requirements with the AHSN To build on recent successes with Life Science studies to enlarge the portfolio of activity in this workstream Q1-2 Challenges Trusts direct funding towards other areas reducing the opportunity for RH&C research delivery teams to maintain level 32

34 of capacity to embrace new studies. Often low numbers of Life Science studies which then provides low option to be selected as a site or to gain experience in this arena. 28 Respiratory Disorders Increase access for patients to Respiratory Disorders studies on the NIHR CRN Portfolio Opportunities Regional activity in all 4 areas of main respiratory disease: asthma; COPD; bronchiectasis; rare diseases therefore there are experienced Principal Investigators in all areas. Plan Engage local staff with a regional LCRN programme of re-engagement and active communication. Ensure support to new respiratory Specialty Lead to re-establish the research specialty group across Yorkshire and Humber. Engaged and enthusiastic specialty lead appointed Yorkshire Cancer Research have recently awarded funding for a large scale community project studying lung cancer CT-Scan screening - The Yorkshire Lung Study. Challenges Further development and growth in DGH s - identification of local expertise Identify areas of excellence regionally (e.g. asthma, ILD) and review of pipeline and existing studies Development of a respiratory research training day to encourage consultants and trainees to engage with research. Review of patient pathways for sub-specialties. Review of primary care portfolio to encourage transitional working following patient pathway. Ensure support and engagement increases to AHP community e.g. physiotherapy services, domiciliary services. Q1 Q3-4 Q2 Q Stroke CRN recruitment to Stroke RCTs should be at least 8% of the 2016/17 Sentinel Stroke National Audit Programme (SSNAP)-recorded Opportunities In 2016 we appointed a new Specialty Lead, Prof Arshad Majid. He provides strong clinical leadership and has extensive contacts globally in relation to stroke research. High success in attracting commercial Plan We will support Professor Majid in his leadership role and in particular, will aim to support and consolidate some of the research expertise in stroke research across the region by; Focused meetings to bring teams together, and Establish what is required to maintain the Q1-3 33

35 hospital admissions research to the region provides a significant opportunity. skills to deliver stroke RCTs aligned to national objectives Challenges A paucity of studies and emphasis on commercial research has reduced recruitment and resulted in some of our traditionally strong trusts not developing their portfolios as well as we might have expected. As a result of this some staff across the region have worked more generically, which has challenged some of the specialist skills required for stroke research particularly in relation to RCTs. We also have relatively few CIs working in our region at the moment. We have recently been designated NIHR BRC centre in Neuroscience which will help us initiate investigator led stroke research. We are planning such studies which could go on the portfolio. We are in discussions with Glycyx Pharma ventures regarding a $5 million research fund for translational stroke research in Sheffield (and maybe also in the region). Prof Majid is in discussion with Pulse therapeutics about bringing the MEDIS hyperacute commercial study to three Y&H sites. 30 Surgery Increase patient access to Surgery research studies on the NIHR CRN Portfolio across the breadth of the surgical subspecialties Opportunities Work in 16/17 identified named leads for surgical subspecialties. Identify perioperative clinical care staff to maximise research interest in non-research groups recruitment potential eg.odps Strong academic base across the region with two Royal College of Surgeons designated CTUs. Plan Active collaboration and support of all PIs and potential PIs through identified Subspecialty Leads - maintain and sustain this important dialogue through a structured communication strategy. We will support close working between sub-specialty leads and leads in related clinical groups, including but not restricted to cancer. We will support the development of locally led studies of surgical technologies Q1-2 Strong biotechnology and engineering collaborations across the region. Challenges Improved communication with subspecialty leads and development of sub specialty portfolio maps. Identification of research nursing workforce to support patient recruitment along the patient pathway. Utilisation of radiology and perioperative workforce to embed research as frontline activity. Continue to grow a definitive specialty group Q1-2 Q1-3 34

36 Identify research resource and capability across the region. supported by a clear vision/strategy. SSS to support the identification of cross-specialty working with oncology, head and neck, urology etc. 35

37 Section 4: LCRN Operating Framework Indicators Please complete Table 4 with details of local plans to ensure compliance with the following 2017/18 LCRN Operating Framework Indicators, adding additional rows to the table where necessary. Table 4: Compliance with LCRN Operating Framework Indicators 2017/18 Indicator Compliance plan Timescale 2.1 LCRN has an identified Lead for each CRN Specialty 2.3 Each LCRN provides evidence of support provided to their Local Specialty Leads (LSLs) to enable them to undertake national activities in respect of commercial early feedback and non-commercial adoption Current Specialty Vacancies: Age and Ageing - Currently been covered by Chris O & Chris R Cardiology to be reviewed and consolidated into one lead Primary Care - Moved to CDL role, intention to re-appoint to this post during Q1 Please refer to appendix 1 for Clinical Divisional Structure and Speciality Lead vacancies Senior nurses appointed to Specialty Lead roles in Injuries & Emergencies and Primary care. Research Midwife shares Specialty Lead role for RH&C. The CRN s outlined programme of support for specialty leads will continue to be implemented to encourage leads to contribute to national activity (see section 3.2 and appendix 2). Local Specialty Leads will continue to be invited to local Early Contact and Engagement meetings to provide clinical leadership and ensure knowledge and early study information can subsequently be used on a national level. A Specialty Lead induction package will be built into the specialty support offer to ensure new specialty leads are able to undertake commercial early feedback and non-commercial adoption national activities. For each local specialty group the network has identified a lay source of expertise as support for researchers. For some groups this is agreed collaboration with an Model working Q1 Q1 36

38 experienced specialist or generalist PPIE group and for others this is lay members who are part of the group. The network will continue to support and strengthen this model in 17/ Each LCRN has a defined approach to communications and action plan aligned with the national communications strategy 5.5 The LCRN has collaborative PPIE work plans across CRN and partners with measurable outcomes for delivery of learning resources National campaigns : One million patients in Primary Care research - Social media drive International Clinical Trials Day/ OK to Ask/Dementia awareness week - wkc 20th May - Work with Partner Organisations; what events are they organising, how can we support, utilise twitter, showcase in bulletin. NIHR Research tables - October (TBC) Other local ideas (to be agreed) : JDR as a New Year s resolution Theatre of Debate - People are Messy - nationally promoted event in collaboration with other NIHR organisations in Yorkshire and Humber. June 22nd in Hull, City of Culture - theme will be hard to reach populations or long term conditions, will reach at least 100 new people. Review of local communications both internal and external to develop better engagement and communication streams with our stakeholders including reviewing and amended intranet site to enable better access to reports and LCRN information. Established cross-y&h NIHR PPI steering group with representation from AHSN, CLAHRC, CRF Leeds & Sheffield, CRN, DEC, HTC, LMBRU & RDS meet throughout the year. At least 5 meetings/teleconferences with 60% attendance per year The Y&H NIHR PPI steering group jointly organise a PPIE NIHR Voices event for patients and public involved in research. Workstreams from this event provide continued collaborative focus for mixed lay/nihr teams and are fed back at the next NIHR Voices event. 1 event - at least 50 lay participants, completed workstream outcomes shared throughout network and nationally. Cross regional group collaborate for ICTD. Q1 37

39 Learning resources shared within region. 17/18 Building Research Partnerships will roll out delivered by existing facilitators. 3 events in 2017/18 with at least 10 participants each. PPIE Office will provide guidance to POs to facilitate collection of Research Experience data. At least 75% of POs will run survey. PPIE Office will conduct usual annual review of PO and active GP Practice websites to ensure information about research participation is publically available Appoint PPIE post Q1 5.6 Each LCRN delivers the Patient Research Ambassadors (PRAs) project 6.1 The LCRN has in place a senior leader with identified responsibility for the wellbeing of all LCRN-funded staff 6.2 Each LCRN has an agreed programme of activities that engage the wider workforce to promote clinical research as an integral part of healthcare for all Currently PRAs in the network aligned to 14 Partner organisations and 3 GP practices. PRA activity reported to Partnership Group at each meeting by Lay Members who are drawn from PRA group. Request for named PRA from POs in February 17 to be confirmed for June PRAs in Yorkshire & Humber PRAs encouraged to register on national page. 22 registered in total PPI Office provides guidance about establishment of PRAs in NHS Organisations including managing as volunteers PRAs invited to annual gathering to share experience, identify learning needs, develop understanding of research participation and where research delivery fits in the research pathway. Name pending outcome of WFD Leads residential and subsequent discussions. Reviewing opportunities to link with our partners with established posts. We will continue our partnership organisation strategy which includes; Regular meetings with partners at intervals no less than quarterly - discussion points include workforce; Thematic meetings which involve a broad workforce integration such as podiatry, specialist nurse, academic staff; Q1 N/A Q1 38

40 CRN input into pre-existing group and community meetings such as the Y&H Retinal Society, the Y&H IBD group, The Y&H Prison and Young Offenders Network, CHAIN and the 0-19 Network Listening exercise with network staff Learning & Development Strategy Work with our GCP Facilitator Community to explore opportunities to extend the delivery of Y&H Core Learning and Development Programme Planned programme for 2017/18 (appendix 3) Advanced Leadership Programme Establish a YH plan to capitalise on learning from this programme to influence future leadership opportunities Link with continuous improvement in regard to project completion through this programme - Diabetes Community Building on WF Intelligence - Specialty leads, develop ability to utilise specialist workforce more efficiently. Consider the R&CH champion model - could this be rolled out across other Clinical Specialities? Review cohort working - develop greater opportunities for cross organisational boundaries/ cross speciality working Review of Research Practitioner workforce - develop career pathways within region Work with WF leaders in POs Explore contractual arrangements - permanent vs. fixed term. What is the state of play within the region Explore opportunities with NHS Apprentice Programme - using the existing model available at Mid-Yorkshire PO. Establish a WF Leaders group attended by PO Research WF Leaders 6.3 The LCRN has a defined approach to developing a culture of Continuous We have a strong and embedded culture of continuous improvement in our region. This is particularly evident through our core team s use of sprint/agile working. At the 39

41 Improvement (Innovation and Improvement) support by an action plan aligned to local and national initiatives and performance metrics time of writing, we are looking for a new lead for continuous improvement who will be able to take on three key workstreams: - Building Better Networks - Creating Self-Improving Teams - Developing Digital Delivery Each of these work streams is described elsewhere in this plan. 7.1 Each LCRN has a completed business development and marketing Profile using the template provided by the National CRN Coordinating Centre 7.2 The LCRN has an action plan for promoting the industry agenda aligned with the national business development strategy Addressed and attached Work with each partner organisation to promote life sciences industry work, presenting at conferences and research days. Explore collaborative working with HTCs and CTRUs to promote a service offering to conduct clinical investigations for local SMEs developing medical devices. Build on success promoting local sites and researchers to a local wound-care company, using established sites to suggest and promote green shoots sites. Promote Primary Care engagement and success to industry partners. Work with the NHSA to build collaborations with LCRNs across the North of England to offer clusters of sites that can deliver research in the North, begin by working on the Gastroenterology Industry Collaborative with the North East and North Cumbria. 40

42 Section 5: NIHR CRN Priorities 2017/18 The CRN Yorkshire and Humber approach to national NIHR CRN priorities is congruent with our strategy for clinical specialties as outlined in section 3 as we have worked to ensure that our clinical strategy is informed and led by the national agenda. 1. Deliver against NIHR CRN strategies As noted below are performance in commercial studies has shown substantial improvement over the past business year and we have plans to build on this during 2017/18. This provides us with a strong platform for engagement with commercial partners and makes us well placed to support the National Business Development and Marketing Strategy. We are working with the other CRNs in the North of England on a joint offer for commercial research. Our successful collaboration in gastroenterology is noted elsewhere in this document and provides a template for working across other specialties. We will work with the Yorkshire and Humber AHSN on the roll-out of the Innovation Research Pathway raising the profile of this initiative amongst our specialty leads and partners and identifying opportunities for innovations to be implemented in the context of a clinical study. Biosimilars: In order to support the NIHR CRN biosimilar strategy we will:- identify a cohort of Investigators willing to conduct clinical trials with biosimilar medicinal products. Opportunities arise in musculoskeletal,oncology, dermatology and diabetes which represent the therapy areas for which the next wave of biosimilars are being developed. identify ways to align NHS England s communications about biosimilars to our research community to help raise awareness. identify opportunities to work with commissioners to understand the uptake and financial benefits from using biosimilar medicinal products. This is particularly important in the context of future focused finance which is supporting value based decisions. share information and raise awareness at our partnership group. provide and communicate visible details for the PI, Site, clinical research experience and patient population to the NIHR CRN in order to populate a catalogue of NHS sites interested in biosimilar research As previously noted in this plan we will build on our already considerable strengths in patient and public involvement with an initiative to increase engagement in children's and young people's research. The success of our oral and dental group in working with schools is an exemplar that can inform both regional and national strategy. The CRNs regional R&D Directors forum supports our close engagement with partners and we will continue to utilise this forum to maintain and forge strong links. The high uptake of research in primary care is evidence of our success in this sector. Our objective for 2017/18 is to develop an integrated approach to working with the NHS partners that focuses on population need and the patient journey as well as on the research strategies of individual organisations. Studies funded by Yorkshire Cancer Research that span primary and secondary care provides a real opportunity to bring partners together in joint working and research and our plans for the roll-out of the studies outlined elsewhere in this plan. 41

43 Our Public Health strategy aimed at identifying populations and specialties of research needed in the region as described in Section 3 will both foster engagement with partners and support the growth of research infrastructure that supports the patient pathway across different NHS sectors. Our communication strategy for the forthcoming year is grounded in celebrating successes in the region and ensuring that the national clinical research agenda is visible to and understood by partners. We have recently held a meeting of clinical leaders to discuss Professor Chris Witty's reflections on his first year as Chief Scientific Adviser to the Department of Health and will be bringing similar discussions to both our Partnership Group and our R&D Directors Forum. We are already active and effective in promoting and publicising local successes and in the forthcoming year will work to link these closely to the impact of research on the quality of care. Our plans for workforce development are discussed at length elsewhere in this plan and include the use of a proportion of their contingency funding to foster new investigators through "green shoots" initiatives and a particular focus on allied health professionals. 2. Deliver on NHS Portfolio Studies to Time and Target Improving HLO2A - CRN Y&H has shown ~ 18% improvement in HLO2A over 2016/17, among the largest improvement of any LCRN. This has been driven by reporting and close engagement with partners, support for specific studies provided by the Study Support Service, expertise and involvement by Specialty Leads. The industry team have used performance data to query proposed targets working with sites and provided training and support in feasibility. Performance is currently 74% with most specialties and partners showing dramatic improvement (currently 11 Specialties are green compared to 5 in 2015/16, 6 partner organisations are green compared to 2 in 2015/16). The improving picture allows for a new strategy to drive further improvement. Partners and Specialties achieving success will be publicly recognised in meetings, LCRN communication and personal letters sent to PO executives; the few remaining areas not showing an improvement trajectory will be supported, using the IOM and Specialty Leads to agree plans for change while the senior management team ensures that these plans have visibility and agreement at the executive level of partner organisations. To drive performance from Amber to Green there will be a focus during 2017/18 on ensuring that study sites have the maximum possible recruitment window by working to shorten study set-up times. The Study Support Service and Business Intelligence Unit will work with partners to bring EDGE data up to data for all industry studies in set up during 2017/18, this will allow analysis and action to ensure that partners are meeting the set up expectations of the Life Sciences industry. This initiative will be the final push which takes HLO2A from amber to green while also supporting proactive management of HLO4 and HLO5A. 3. CRN Digital Programme The network has already had significant success in supporting study recruitment through social media. We will build on this and the forthcoming year by supporting researchers to explore opportunities for both study promotion and digital data capture as part of our early engagement process. We are engaging with regional initiatives to build a digital research infrastructure that rest on the strength of our local Higher Educational Institutions in this area, for example the living in Leeds collaboration between Leeds University, health care providers in the city, and Leeds City Council. See section 6. 42

44 4. Maximise use of CPMS/LPMS Each Clinical Research Network (CRN) introduced a Local Portfolio Management System (LPMS) to streamline and provide a data platform for the Central Portfolio Management System (CPMS) to collect performance data. All partners within CRN Y&H have procured and implemented the EDGE system as their LPMS and during 16/17. Over 17/18 will promote and support the expansion of LPMS usage within YH. This will be against a set of principles to support study performance and data collection: Principle 1 - All patient status workflows to be maintained/completed. Where record is not occurring with activity then the PO must record within a maximum period of 14 calendar days, from activity, plus have a clear and robust plan to reduce the time period between activity and record. This plan is to be implemented with immediate effect. Improvement targets will be negotiated and managed with the CRN. Principle 2 - All data points of the CRN Minimum Dataset to be completed. Using the latest version of the dataset available Principle 3 - Where appropriate, Study Support Service (SSS) data is to be collected at site and reported via EDGE in collaboration with CRN staff. Principle 4 - PO s to increase their management of studies by increased user base within their organisation or using the functions of the system in line with local requirements and regional initiatives. Next steps : Develop a plan for of EDGE within Primary Care and Non-NHS sites HLO 1 (recruitment) - monitor via BIU with comparison/matching with ODP, await CC confirmation of go live date (ongoing) Contact Clinical Trial Units within region Contact Clinical Trial Facilities CRF have CRF manager system (a requirement from NIHR) 5. Optimise Research Delivery We have recently undertaken a review of our cohort research workforce and will work to ensure that this is aligned to flexible study delivery particularly across community and secondary care as outlined elsewhere in this plan. We already estimate value for money in terms of cost per recruit for organisations but recognise that this is a global measure that does not capture the granularity of study delivery. In the forthcoming year we will work to identify studies which are particularly expensive and whilst continuing to support these as appropriate will work with researchers and partners to identify areas where cost can be reduced. By the same token we recognise that not all research activity is captured by the metric of study recruitment and we will use contingency funding to ensure that work such as participant identification is appropriately supported. 43

45 Section 6: Other local innovation and initiatives Clinical and specialty areas that we will continue to support include:- PALLIATIVE CARE This is a significant strength under Professor Mike Bennett and Professor Miriam Johnson's leadership. We will continue to expand hospice engagement and will identify where research delivery has the potential to embrace multiple specialties e.g. across cancer and respiratory disease WOUND CARE Wound care provides a specialty focus within Y&H CRN with our specialty lead Professor Jane Nixon leading a novel "wound research network" a multidisciplinary group of academics and CTUs spanning multiple disciplines. This allows for early intelligence of developing studies and highlights Y&H as having significant strengths in the area as an example wound care is now embedded as a sub theme in the successful Leeds CTRU bid to RCS Surgical Trials Unit. We will build on emerging local multidisciplinary strengths. A strong collaboration between colleagues in vascular surgery diabetes and tissue viability was successful in securing HTA funding was secured for the MIDFUT trail of diabetic foot management currently has a number of further projects in development including NIHR grant applications led by new AHP investigators. We will optimise commercial opportunities through a clear contact process to consider new studies in Y&H and development of a Y&H research "brochure" to make strengths more visible. ALLIED HEALTH PROFESSIONALS As noted elsewhere and above the CRN has a strong AHP research community. Our overarching aim for the forthcoming year is to increase the number of AHP investigators in the region. Specific objectives include:- Build links with paediatric and pharmacy networks Further strengthen AHP links with the RDS to support the emergence of a strong group of AHP investigators Secure intelligence and scope opportunities around workforce by using a named AHP identified for each profession Support academic career pathways for AHPs e.g. support the development of recently appointed Honorary Associate Clinical Professors in Leeds. PHARMACY Pharmacy represents another significant area of strength in Y&H CRN. Our pharmacy champion Dr Mahendra Patel is a Board Member of the Royal Pharmaceutical Society (RPS) and active member of the Primary care Steering group. Initiatives he is leading include:- A national campaign to be delivered in collaboration with the Royal Pharmaceutical Society over the course of 17/18 highlighting pharmacists role in diabetes research. Liaising with the National Diabetes Clinical Director, to identify research opportunities in relation to South Asian diaspora Development of a Pharmacy Research Evidence & Evaluation Toolkit (REET) through the RPS. Research Ready pharmacies and GPs within Y&H CRN will be aligned to the REET. This initiative complements our cluster model for general practice research. We will work to map Research Ready pharmacies to Research Ready GP practices in Yorkshire and Humber. If successful this is a model that could be adopted by other regions. The 44

46 RPS support this approach and will help to publicise the model. This will include publicity on their website for the early stages of the project. There are currently 15 Research Ready pharmacies in the Yorkshire & Humber region. We aim to at least double this number in the next 12 months. Development of a local template which can be made national with the support of the RPS Research team to gather case studies which illustrate the benefit of community pharmacy involvement in research and research support activity locally. Again, if successful this may be rolled out nationally by the RPS Dr Patel aims to become an NIHR training pharmacist advocate to support and help pharmacists better access NIHR Fellowship Awards there is not yet one for pharmacy. Dr Patel is currently working with the NIHR to develop a pharmacy focussed 1 hour webinar with Q&A to promote engaging in research through pharmacy, similar to that already existing for nurses and doctors. The RPS would consider co-branding the webinar. Researcher engagement with Research Ready Pharmacies Researchers continue to express concern over involving community pharmacy in their studies and this is compounded when there is no quality standardisation. We will host a joint seminar to support both pharmacists and GP practices to become research ready and to help share practice and experiences to promote research within the region. BROADENING THE REACH Our strategy for increasing access to research is outlined elsewhere in this plan. This will be supported by a number of initiatives. We build on our work with academic and clinical colleagues to support the development of cohort studies which will impact on population needs of our region. We will support local and regional projects to establish communities of consent, for example Living in Leeds. We work to ensure that non NHS partners share the vision of increasing access to research and feel able to engage with clinical research with the assurance of robust governance frameworks. We will working with commissioners and highlight the opportunities for economic efficiencies through research, for example in the areas of biosimilars. Aligning to regional initiatives e.g. Bradford a City of Research We will build on our already effective working relationships with our NIHR partners and the Yorkshire and Humber AHSN. MEASURING IMPACT AND SHARING OUTCOMES We will take forward our joint initiative with CLAHRC to measure the impact of portfolio research on our POs and patients. We will work with our PPI groups and local research ambassadors to identify effective ways of sharing the impact of local research with patients. Our Improvement Plan for 2017/18 has the following key strands: Building Better Networks Creating Self-Improving Teams 45

47 Developing Digital Delivery The Building Better Networks strand will build on our pilot work, creating Learning Communities. Learning Communities are groups of people who want to improve their practice by reflecting on the complex judgements that they make, day in day out. ( This work is been supported through a collaboration with Newcastle University. Following a successful launch with our diabetes research nurse community, we will facilitate and support more of these groups. The primary aim of this work is to foster collaboration, across the network, and to allow for a positive error culture whereby the difficulties practitioners face becomes a basis for improvement. We have recently developed a training course that can be delivered to teams of research practitioners, teaching them the fundamentals of improvement science. This course is delivered in partner organisations and evolves into a coaching relationship with people responsible for delivering research. The aim of the course is to create an improving mindset, then to provide access to the tools people might need to improve their own practice. This supports the development of a virtuous cycle of self improving teams encourage self-improving teams. The Yorkshire and Humber Clinical Research Network has pioneered the use of digital technologies in the delivery of research. In 2017/18 we have ambitious plans to build on this work: We are actively pursuing the vision of End to End Digital support for NIHR Portfolio research hosted by the network, by maximising leverage from 3rd Party digital clinical research solutions (e.g. FARSITE for feasibility and recruitment; CPRD/ResearchOne for data access) and by maximising current systems to support enhanced performance in line with NIHR SOPs (EDGE and NIHR Hub). We are exploring (with external partners) the possibility of developing a research delivery platform. This would enable the rapid deployment of digitally delivered studies. For example, the platform would include facilities to deploy online consent and online recruitment, allowing one study to benefit from the development work done by another. We are collaborating on a research study supported by an European Horizon 2020 grant and aim to support this from the design stage through to the delivery of the study. Our aim is to use this project as a proof of concept, embedding digital delivery methods at every possible step working closely with CRN CC. We have successfully translated many of our operational workflows online. For example, using the Trello system we are able to track our meetings and actions with our partners. We aim to develop this work to be more robust as a supporting tool for our business. Yorkshire and Humber will work with the NHSA and the North East and North Cumbria Clinical Research Network to implement the Gastroenterology Industry Collaborative. We will work with our research active Gastroenterology partners to assess and streamline set-up and delivery processes, investing in a single point of contact for relationships and set-up activities to drive rapid efficient study set-up and excellence in delivery over clusters of Yorkshire and Humber sites. We will work with the North East and North Cumbria to use our combined clinical expertise to attract Gastroenterology research sponsors to the North of England. Our aim will be to grow the number of multi-site, commercial sponsored Gastroenterology projects conducted in Yorkshire and Humber (of 13 commercial Gastroenterology studies open to recruitment in 2016/17 only 2 were conducted across more than 1 sites). The initiative will aim to build research capacity and expertise at green-shoots sites with the aim of bringing high quality research to more patients in Yorkshire and Humber. 46

48 Section 7: Financial Management 7.1 Please describe clearly and in appropriate detail the local model for allocation of LCRN funding for 2017/18 We have aimed to minimise the impact of the 1,046,827 funding reduction to the Network on our Partner Organisations (PO s) through the release of savings from across central budgets and retaining a modest reserve. Consequently a total of 385,949 has been released from central budgets (37%) and 660,878 (63%) has been released from PO s. The model for the distribution of funding to our PO s continues to be linked to activity (studies, recruitment and complexity) and performance. Allocations have been based on recruitment targets offered by PO s and have been weighted to reflect the average mix of complexity over the most recent 2 ABF years. A central ring-fenced budget has been retained for Primary Care/Community to support the anticipated growth across the sector and to promote initiatives which embed research delivery within GP practices and community services. Funding has been retained within the central budget to support a flexible and responsive workforce through the cohort teams and cross sector working will be a particular focus for the forthcoming year. A modest reserve, currently totalling 458,982, has been retained representing 1.8% of the total allocation for the Network. This will be used to support clinical and strategic priorities throughout the year. 7.2 Describe the arrangements within the LCRN Host Organisation for financial management of the CRN funding The Host ensures financial management and reporting of Hosted Networks complies with NIHR requirements and Audit recommendations. In compliance with NIHR requirements, the Host was subject to an internal audit inspection in February 2015 which focused on the minimum scope requirements specified by the CRN Coordinating Centre followed by a further audit in December 2015 which reviewed the Trust s governance framework for hosted research networks to ensure accountability is transparent. The LCRN annual financial plan is approved by the Host Trust Board of Directors and quarterly in year monitoring and reporting back to the Board is facilitated through the Host Representative to the LCRN and the nominated Host Executive Director. Financial management of CRN funding is supported a dedicated Research Financial management team within the Host Finance Directorate. Network income and expenditure is separately identified on the Host ledger through a ring-fenced budget reporting structure. 47

49 7.3 Describe arrangements for supporting LCRN Partners in their financial management of LCRN funding LCRN Annual Delivery Plan 2017/18 Financial management advice and support is provided to POs through: The Financial Advisory Group - a reference group of research finance experts from PO s established to advise the Executive on matters of research finance. These include collective approaches to commercial income, addressing audit recommendations, and ensuring that PO s are fully informed about uses of network funding and the extent of their autonomy in making network funding decisions. Mid-year review meetings. Tailored Support The Host finance team provides tailored support to meet the requirements of individual POs. Host Finance representation across key groups This includes the Network executive team, Partnership Group, R&D Operations Group. 7.4 Please provide details of any plans that you anticipate impacting on the local model for allocation of LCRN funding for 2018/19 We will continue to review the model throughout the year and make refinements in light of PO feedback, PO performance, anticipated changes to Network allocations and changing clinical and strategic priorities. 48

50 Section 8: LCRN Host Organisation Approval Please confirm that this Annual Plan has been, or is scheduled to be, approved by the LCRN Host Organisation board: Signature: Sandi Carman Name and position of signatory: Sandi Carman, Non Executive Director/Deputy Chief Executive Date of signature: 19th April 2017 Date of LCRN Host Organisation board approval: 19th April

51 Appendix 1 - Clinical Divisional Structure 50