Delivering clinical research to make patients, and the NHS, better NIHR CRN: North Thames Prof Lyn Chitty – Clinical Director

NIHR Landscape

Clinical Research Network Provide research support in clinical teams to facilitate recruitment to portfolio studies Research nurses Data managers Variety of other posts Develop systems to identify and recruit participants CSP – gaining NHS permissions for research studies PERFORMANCE MANAGEMENT of DELIVERY

Launch of National Cancer Research Network Creation of Mental Health Research Network UKCRN established along with four additional Research Networks, making up the 6 therapy areas recognised today National Institute for Health Research created to implement Government Health Strategy “Best Research for Best Health” Primary Care and Comprehensive Research Networks created NIHR CRN is formed to deliver clinical research in England / Dr Jonathan Sheffield joins NIHR CRN as Chief Executive Officer High Level Objectives and Performance Management Framework introduced 2012 Health and Social Care Act comes into effect bringing new NHS structures Time for the National Institute for Health Research Clinical Research Network to evolve Our journey so far…

We have tripled the annual number of patients into studies in six years

What has changed? Where were we?What have we moved to? Hosting 9 NIHR CRN Network Coordinating Centres with 7 individual hosting agreements 1 NIHR National Coordinating Centre (incorporating clinical thematic leadership) 102 NIHR CRN local research networks Across 70 NHS organisations 15 Local Clinical Research Networks each hosted by a single NHS organisation Geographical coverage Inconsistent national coverage for clinical research into key therapy areas Full national coverage for clinical research into all key specialties Complex geographical configurationSimplified geographical configuration Resource coordination Dispersed model of workforce coordinationSingle model of workforce coordination, responsive to local need Dispersed and fragmented oversight of deployment of resources Strategic oversight for the deployment of resources at national / local partner level Inconsistent models of funding allocation/use Consistent models of funding allocation/use Organisational structures Complex organisational structureStreamlined organisational structure Inconsistent models of clinical leadership across networks Consistent model of clinical leadership across networks Partner organisations receiving multiple and confusing funding streams Partner organisations receiving single coordinated funding stream

Ensure patients will benefit from a consistent approach to clinical research with key specialties being available in all geographies Provide transparent, consistent governance and clear accountability Ensure funders (including industry) will benefit from a consistent integrated approach to research delivery Be platform to share best practice in research delivery and improve learning opportunities and career development A simplified structure will

LCRN core roles and groups Partnership Group Reviewing and agreeing, LCRN business plans and reports, Annual financial and business plans, Development plans, Annual Report Informed by financial and activity data Active oversight and constructive mutual challenge of LCRN activity and performance Monitoring of any compliances required of Partner organisations. Host Chief Executive Host Executive Director LCRN Clinical Director Clinical Research Leads Clinical Research Specialty Leads Chief Operating Officer Support Team Cross-Divisional Team Divisional Managers / Teams Operational Management Group Clinical Research Leadership Group Executive Group

High Level Objectives 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, 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% B: Proportion of non-commercial studies achieving or surpassing their recruitment target during their planned recruitment period 80% 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 600 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 75% 4. Reduce the time taken for NIHR studies to achieve NHS Permission through CSP Proportion of studies obtaining NHS Permission at all sites within 40 calendar days (from receipt of a valid complete application by NIHR CRN) 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 calendar days of NHS Permission being issued or First Network Site Initiation Visit, at confirmed Network sites 80% B: Proportion of non-commercial studies achieving first participant recruited within 30 calendar days of NHS Permission being issued 80% 6. Increase NHS participation in NIHR CRN Portfolio StudiesA: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio studies 99% B: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio commercial contract studies 70% C: Proportion of General Medical Practices recruiting each year into NIHR CRN Portfolio studies 25% 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 13,500

CRN: North Thames North Central London, Essex & Herts Formed by merging 11 networks Hosted by Barts Health 17 Acute Trusts 7 Community & Mental Health Trusts 20 CCGs 4 HEIs [2 medical schools] Population 5.7M (10% NHS) Budget £29.4M (+£0.93M RCF) >10% of NIHR portfolio lead from North Thames

: : : : : : : : : Ipswich M25 M11 UCLHFT GOSH BHT ELFT MEHFT CIFT RFLFT TPFT RNOHT WHHT BCFHT LDHFT PAHT BTUHFT HCT MEHT HUHFT WHT NELFT SEPFT SUHFT BHRUHT BEHHT NMUHT London Bedford Herne Bay Ashford Canterbury Guildford Maidstone Basildon Colchester High Wycombe Slough Reigate Dartford Watford Dunstable Stevenage Brentwood Chelmsford

Chief Operating Officer Communications Officer & Office Manager Admin Officer Head of RM&G CSP Co-ordinator 2.0WTE Pharmacy/Medical Exposure Manager Permissions Centre Co- ordinator 1.0WTE per centre Head of Finance & Information Information Systems Officer Finance & Information Manager Finance Officer Performance Reporting Officer Industry Operations Manager Research Delivery Manager 6.0WTE Deputy Delivery Manager 6.0WTE Admin Officer 3.0WTE Divisional Portfolio Officer 12.0 WTE Clinical Director Industry Co- ordinator PCPIE Manager Pharmacy /Medical Exposure Co- ordinator

CRN: North Thames Governance Structure

Divisional structure DIVISIONS Division 1 Speciality Leads for 5 different tumour groups Division 2 Diabetes & metabolic and endocrine disorders, stroke, cardiovascular disease, renal disorders Division 3 Children, genetics, haematology, reproductive health and childbirth Division 4 Dementias and neurodegeneration, mental health, neurological disorders Division 5 Primary Care & ageing, oral and dental health, health services and research delivery & public health, musculoskeletal, dermatology Division 6 Anaesthesia/peri-operative medicine, pain management & critical care, injuries/emergencies, surgery, ENT, infectious diseases/microbiology, ophthalmology, respiratory disorders, gastroenterology, hepatology, interventional radiology

The studies and the people Div 1 Div 2DIV 3Div 4Div 5Div 6 Open studies (commercial)(47)(23)(29)(24) (56) Workforce (FTE) Recruitment ( ) Interventional

Recruitment CRN: NT 2012/1358, /1454, /1564,939 (target ~58,000)

CCG Recruitment 2013/14 vs 2014/15

Recruitment by CCG 2013/14 vs. 2014/15

CCG Recruitment by Specialty 2014/15

No. GP Practices by CCG

Active GP Practices by CCG 2014/15

£30M + £1M RCF Initially based on workforce pre-April Creating a flexible workforce Divisions build business cases with Trusts To replace departing staff To fund new positions Resource allocation model to support current and new workload (not rewarding past activity) but appropriate to needs Total recruitment target for NIHR ~58,000. We have set local targets with trusts but need to be aiming high (65,000 = 10% of the NHS)

RM&G Changes National focus on study support service HRA Local provision changes Harmonisation roll-out across entire CRN CRN-wide coordination

Working in the CRN Develop career pathways Workforce review Standardised/Job Titles JDs Developing a graduate training scheme Flexible working Induction Training and GCP Dissemination events

Divisional Contacts Clinical Research LeadResearch Delivery Manager (Deputy) Division 1Adele Fielding/David ChaoDawn Beaumont-Jewell Aderonke Adebiyi (Jennifer Godwin) Division 2David WheelerPhil Smith (Jill Gallagher) Division 3William Van’t HoffDawn Beaumont-Jewell (Heidi Chandler) Division 4Helen KillaspyTania Page (Sarah Styles) Division 5David Isenbeg/Lynis LewisAderonke Adebiyi (Christine Menzies) Division 6Margaret JohnsonSharon Barrett (Belinda Theis)

Contact Us and phone contacts: Office base for core team: 4 th Floor, 170 Tottenham Court Rd London W1T 7HA Follow us on