Allowed more focus on contract and budget review and involvement in the Service Improvement Programme on costing at the NIHRPerformance Management has been key, acting as a partner with both Trusts and commercial sponsors to bring us together as one team to deliver in both set up and recruitment phases: Includes early engagement, attending feasibility meetingsIndustry Event 21st March, development of literature, focus on Industry at the Specialty Group Meetings and also engaging with the Topic Networks: NCRN, PCRN, MHRN, working with nurses across the Trusts and regular meeting with the governance team, regular contact with sponsors (e.g. Novartis)
The mental Health study is with Shire pharmaceuticals looking at the use of an amphetamine derivative in those with severe depression
The key objectives were to explore GPs and Practice/Finance Directors:expectations surrounding industry researchif the GPs/GP practices are not motivated what are their reasons and what would motivate them to get involved in industry researchwhat experience the GPs/GP practices have in undertaking industry research; whether they have direct contact with industry sponsors and how frequentlythe barriers (real or perceived) to their participation in industry researchtheir perception of the industry time targets specifics that the GPs identify would help/assist them to support industry research what the GPs perceptions of the NIHR networks aretheir opinions on whether the provision of a research nurse would assist them to participate in industry research. If provided their views on how to coordinate this. The secondary objectives of this project were:To develop site profiles for all the GP practices who agree to participate in this project.To compare the “Expression of Interest” (EOI) process, timelines and “layers” in PCRN EMSY compared with the Topic Specific Research Networks. To consider the suitability of the EOI circulated during the life cycle of this project for primary care
Joint working the CRN perspective Professor Oleg Eremin
Joint Working: the CRNPerspectiveProfessor Oleg Eremin, Clinical Director | TCLRN, Nottingham UniversityHospitals NHS Trust
Trent Comprehensive Local Research NetworkClinical Research NetworkJOINT WORKING :THE CLRN PERSPECTIVEProfessor Oleg EreminClinical DirectorTrent Comprehensive Local Research Network24th May, 2013
Trent Comprehensive Local Research NetworkClinical Research NetworkOne of 25 CLRNs in England, one of 2 in East Midlands.(established mid 2007)Has a large population (2.83 x 106) living in large urbanconnurbations and large sparsely populated rural counties.Covers 3 counties [Derbyshire, Lincolnshire andNottinghamshire] – large geographical area.Multiple sites of socio-economic deprivation (many verydeprived).TRENT CLRN : BACKGROUND
Trent Comprehensive Local Research NetworkClinical Research NetworkComplex, multidisciplinary organisation with differing serviceconfigurations, clinical priorities and research excellence.15 NHS Trusts6 Primary Care Trusts (ceased April 2013)3 Mental Health Trusts5 Acute Trusts, Secondary & Tertiary Care1 East Midlands Ambulance Service4 Higher Educational Institutions4 Universities(Nottingham, Lincoln, Derby, Nottingham-Trent)6 Topic Specific Research Networks3 CRNs, SRN, MCRN, MHRN, DRN, DeNDRoNPrimary Care Research NetworkTRENT CLRN : BACKGROUND
Trent Comprehensive Local Research NetworkClinical Research NetworkTRENT CLRN CORE TEAMClinical Director: Professor Oleg EreminSenior Manager: Janet BoothroydLead RM & G Manager: Sheila O’MalleyIndustry Manager: Dan KumarLead Research Nurse: Penny ScardifieldSenior Research Nurse: Ali RaynorInformation Manager: Richard HartSenior RM & G Manager: Hannah FinchLead Network RM&G Facilitator: Christine BrindleyRM&G Managers: Kelly Rowe, Sue BarklieIndustry Research Officers: Carl Sheppard, Nick HamiltonInformation Coordinators: Dave Papworth, James Fox, James LeatherlandRM&G Facilitators: Alison Thorpe, Karen Asher, Mays Jawad, Ruth DoyleAdministrators: Jenni Dunne, Alex RussellCSP Coordinators: Rebecca Denton, Simon Squire, Amardeep Sagoo
Trent Comprehensive Local Research NetworkClinical Research Network
Trent Comprehensive Local Research NetworkClinical Research Network
Trent Comprehensive Local Research NetworkClinical Research NetworkTRENT CLRN EXECUTIVE GROUPProfessor Oleg Eremin: Clinical Director, Trent CLRN (Chair)Mrs Janet Boothroyd: Senior Manager, Trent CLRNDr Teresa Grieve: Assistant Director of Research & Development,Derby Hospitals NHS Foundation TrustProf Nick Manning: Professor Social Policy and SociologyUniversity of NottinghamProf Tony Avery: Professor of Primary CareUniversity of NottinghamDr Brian Thomson: Research & Innovation DirectorNottingham University Hospitals NHS Trust
Trent Comprehensive Local Research NetworkClinical Research NetworkSpecialty Group NameAge & Ageing Dr Tahir MasudDr Opinder SahotaCardiovascular Dr Justin CookeDermatology Dr Adam FergusonEar Nose Throat Prof Deborah HallGastroenterology Prof Chris HawkeyGenetics Dr Rachel HarrisonHepatology Dr Steve RyderInjuries and Accidents Dr Frank CoffeyMetabolic & Endocrine(not diabetes)Prof Ian MacDonaldDr Peter MansellMusculoskeletal Dr Chris DeightonNervous System Disorders Prof Cris ConstantinescuPaediatrics (non medicines) Dr Jon DorlingPalliative Care Dr Andrew WilcockRenal Dr Chris McIntyreReproductive Health andChildbirthProf Jim ThorntonDr George BuggRespiratory Prof Alan KnoxSurgery Prof Dileep Lobo
Trent Comprehensive Local Research NetworkClinical Research NetworkTo provide a high quality NHS clinical researchinfrastructure and research management andgovernance framework.• Clinical research nurses / officers (secondary and primary care).• Sessional support for clinicians (all disciplines).• Service support costs (additional clinical services and diagnostictests eg pharmacy, radiology, pathology).• Implementation of a coordinated system for gaining NHSpermissions (CSP) to ensure, uniform, high quality and expeditiousdelivery of research management & governance (RM&G approval).TRENT CLRN : CORE FUNCTIONS
Trent Comprehensive Local Research NetworkClinical Research NetworkOperating Framework (2008)“ … to double the number of patients taking part in clinicaltrials/studies over the next five years.”* [7,500 in 2008 / 09 ---> 21,000 in 2012/13]Topic Specific Research NetworksCancer, Stroke, Medicines for Children, Mental Health, Diabetes andDeNDRoN.Have received support, where it is lacking or needs extra resource inspecific areas of the network, to achieve optimal research output andexpansion.(Tripartite Working Arrangements).Primary Care Research NetworkSpecial support has been given to primary care which has beenunder-funded centrally.TRENT CLRN : RESEARCH PRIORITIES
Trent Comprehensive Local Research NetworkClinical Research NetworkComprehensive Clinical Research Network• 17 Local Specialty Groups (SGs) & Leads (12 NUHT, 3DHFT, 1 CRHFT, 1 EMAST) are a key development.2 Local Priority Groups : Palliative Care and DeNDRoN.• 3 National Leads : Dermatology (HW); Surgery (JS);Hepatology (SR).Commercial Studies and Trials• Top priority over the past 2 years• Established Industry Team (industry manager, 2 supportofficers, administrator).TRENT CLRN : RESEARCH PRIORITIES
Trent Comprehensive Local Research NetworkClinical Research Network• Recruited into 81 Commercial Studies in Trent in2012/13, 20% increase on 2011/12 total.• Trent CLRN is ranked top out of 25 CLRNs inEngland for recruitment to time & target into CCRNCommercial Studies that closed in 2012/13 (NIHRCommercial Activity Report, published 13/5/13).COMMERCIAL PERFORMANCE INTHE LAST 12 MONTHS
Trent Comprehensive Local Research NetworkClinical Research Network• Trent CLRN is in the top 9 out of 25 CLRNs inEngland („green rated‟) for recruitment into openCommercial Studies in 2012/13.• The median time (26 days) for NHS Trust approvalsfrom receipt of a valid SSI application was rated„Green’ (below 30 calendar days) for the year2012/13.COMMERCIAL PERFORMANCEIN THE LAST 12 MONTHS
Trent Comprehensive Local Research NetworkClinical Research Network• We work in partnership with our 2 affiliated groupleads and our 17 specialty group leads across a widerange of disease areas.• Trent has strong and expanding links with Academia, inparticular, The University of Nottingham (e.g.neurological sciences, reproductive health)COMMERCIAL PERFORMANCEIN THE LAST 12 MONTHS
Trent Comprehensive Local Research NetworkClinical Research Network• Expansion of the Trent CLRN Industry Team byappointment of an additional Industry Support Officer.• Focus on robust feasibility and early engagement, anddeveloping good working relationships with researchteams in Trent.INDUSTRY STUDIES IN TRENT CLRN:TOP PRIORITY IN 2012/13
Trent Comprehensive Local Research NetworkClinical Research Network• Performance management and regular audit ofcommercial research activity by CLRN.• Raising the profile of industry studies within NHS Trustsin Trent.• Integration with RM&G processes and single point ofescalation.INDUSTRY STUDIES IN TRENT CLRN:TOP PRIORITY IN 2012/13
Trent Comprehensive Local Research NetworkClinical Research Network
Trent Comprehensive Local Research NetworkClinical Research Network• Emergency Dept: Significant over recruitment in adifficult setting with a previously commercially naiveresearch area.• Hepatology: Key Opinion Leader, National SpecialtyGroup Lead, extensive database of research readypatients and with significant commercial trial portfoliorecruiting to time and target.SUCCESS STORIES ANDKEY DEVELOPMENT AREAS
Trent Comprehensive Local Research NetworkClinical Research NetworkSUCCESS STORIES ANDKEY DEVELOPMENT AREAS• Ophthalmology: Commercially experienced Investigatorsat two Acute Trusts with excellent recruitment records indifficult to recruit to trials.• Cardiology: Keen interest across all 5 Acute Trusts withpro-active Specialty Group Lead and strong track recordof recruitment at the major Trusts.
Trent Comprehensive Local Research NetworkClinical Research Network• Respiratory: Significant patient population due to historyof mining in the region and R&D Lead keen to expandcommercial activity with the use of a newly establishedclinical research facility.• Mental Health Research Network: Provided support toset up the first commercial CTIMP study atNottinghamshire Healthcare NHS Trust; appointment of aClinical Lead to drive the agenda forward.SUCCESS STORIES ANDKEY DEVELOPMENT AREAS
Trent Comprehensive Local Research NetworkClinical Research NetworkPRIMARY CARE RESEARCH NETWORKCOLLABORATIONIn partnership with the Trent Hub of the Primary CareResearch Network East Midlands and South Yorkshire(PCRN EMSY), involved in increasing GP participation incommercially sponsored research – Report in finalstages.
Trent Comprehensive Local Research NetworkClinical Research Network• The primary aim of the project is to identify themotivation behind and barriers to GP participation inindustry research.• To develop site profiles for all the GP practices whoagree to participate in this project – sent on to industry(e.g. Novartis).• Key opinion leader with track record of recruitment totime and target.PRIMARY CARE RESEARCH NETWORKCOLLABORATION
Former miningarea with highlevels ofdeprivationand healthinequalitiesLarge, dispersed ruralareaLargemigrantworkforceHigh levels ofavoidable mortalityegsmoking, alcohol, self harmHighest rate of hipfractures inEnglandLeicesterforecast to beBritain’s first‘majorityminorityethnic’ city by2012ZerodeprivationTop 10% lifeexpectancyCorby has lowestlife expectancy inthe region (bottom5%)Significant migrantworkforceEMAHSN Geography – where are we?Multi-ethnic, diverse, metropolitanpopulations in Leicester, Nottingham andDerbyStark difference in deprivation, and lifeexpectancy between the city and county25
Trent Comprehensive Local Research NetworkClinical Research Network• Trent CLRN Industry Team engaged with East MidlandsAHSN (Carl Edwards) and looking at the ways that wecan work more efficiently and effectively together.• Trent CLRN Industry Team is working with Carl Edwardsto link into the Industry Advisory Panel, once the ClinicalResearch Themes have been finalised and AHSN licencegranted.WORKING WITH THE ACADEMIC HEALTHSCIENCE NETWORK
Trent Comprehensive Local Research NetworkClinical Research NetworkREAL WORLD DATA AND TRIALS• The UK’s share of global commercial trial activity hasdecreased significantly in the 21st century.• There are various reasons for this: A slow starttime, poor recruitment to time and target and high costsfor trial activity, compared with other countries (e.g.Eastern Europe).• This trend is beginning to reverse and improvements innumbers of studies and their delivery is occurring inTrent and the U.K.
Trent Comprehensive Local Research NetworkClinical Research NetworkREAL WORLD DATA AND TRIALS• ABPI has suggested a strategy for the U K, ensuringthat clinical trials / studies are done in a timely and cost-efficient way, namely the use of real world data (RWD).• Defined as “Data collected outside the controlledconstraints of conventional clinical trials to evaluatewhat is happening in normal clinical practice.” (ABPI).• RWD compliments and augments RCT data and canimprove performance in a range of trial settings.
Trent Comprehensive Local Research NetworkClinical Research NetworkREAL WORLD DATA AND TRIALSThe NHS is uniquely placed to participate in RWD trials.• Inclusive national health system free at the point ofentry.• Patient data (comprehensive, electronic) is held in anumber of different formats and systems in the NHS(primary care, hospitals, registries, social care).Opportunity for linking and integrating these systems.• GP prescribing.
Trent Comprehensive Local Research NetworkClinical Research NetworkCOPD : THE SALFORD LUNG STUDY• The Salford Lung Study is a world–first “real-life” clinicaleffectiveness study.• Only possible because of Integrated Electronic RecordData between Primary and Secondary Care.• An enormous logistical effort: 4232 patients, 50+ GPs, 58community pharmacies, 50+ community nurses, HospitalSafety Team and investigations and GSK.• Will provide important information for clinicians, healthcaredecision makers and most especially patients.Presented by Prof M Gibson at Trent CLRN Industry Event, March 2013
Trent Comprehensive Local Research NetworkClinical Research Network• Multinational, prospective, observational study in patients withunresectable or metastatic melanoma with a minimum of 3years follow-up. (Bristol-Myers Squibb)• Study is not designed to test any hypothesis and has thefollowing objectives:1. To estimate the incidence and severity of adverse reactionsand their management in adult patients treated withipilimumab in the post approval setting. (ipilimumab; humanMAb specific for CLA-4 on T cells, potentiating anticancer Tcell responses)REAL WORLD STUDY IN TRENT (ULHT)
Trent Comprehensive Local Research NetworkClinical Research Network• Study is not designed to test any hypothesis and has thefollowing objectives:2. To describe patterns of care for adult patients receiving anytherapy for unresectable or metastatic melanoma.3. Secondary objectives are to describe real world use ofhealthcare resources and overall survival.REAL WORLD STUDY IN TRENT (ULHT)
Trent Comprehensive Local Research NetworkClinical Research NetworkRationale for Global Health Outcomes Objectives:• To achieve an understanding of physician decision-making in thetreatment of unresectable or metastatic melanoma post launch ofipilimumab.• To establish that the clinical benefit observed in the original trial iscomparable to that observed in a real world population.• To ascertain if the real world prospective data on patterns ofcare, health care research utilisation and real world treatmenteffectiveness will more reliably inform healthcare providers andindustry about the cost effectiveness and benefits of ipilimumab.REAL WORLD STUDY IN TRENT (ULHT)
Trent Comprehensive Local Research NetworkClinical Research Network• Clinical research in the UK, in particular, involvingindustry studies / trials, is facing significantchallenges in the global market. The NHS incollaboration with the NIHR is uniquely placed topursue a wide range of world class research and toadapt to the changing global healthcare and industryinitiatives.SUMMARY
Trent Comprehensive Local Research NetworkClinical Research Network• Trent CLRN is a well established andresourced, effective and successful Clinical ResearchNetwork, with a strong commitment to support andimplement commercial NIHR approved studies.• Trent CLRN is in the process of undergoing atransition, merging with theLeicestershire, Northamptonshire and Rutland CLRNinto the EMLCRN, within the umbrella of the newEMAHSN.SUMMARY
Trent Comprehensive Local Research NetworkClinical Research Network• A top priority for Trent CLRN and the subsequentEMLCRN in 2014, is to continue to engage activelyand constructively with industry, improve further themetrics of trial delivery, explore innovativecollaborations (e.g. real world studies) and make EMthe preferred site for commercial studies / trials in theUK.Website: http://trent.crncc.nihr.ac.ukSUMMARY