Bhutta, Mahmood

Blackshaw (UCL), Helen

Philpott, Carl

Schilder, Anne

English

H. Blackshaw

C. Philpott

M.F. Bhutta

S. Cooper

A.G.M. Schilder

Crossref

Clinical Otolaryngology

Getting involved in ENT clinical research in the UK; how can the NIHR Clinical Research Network help?

Blackshaw, Helen

University of East Anglia digital repository

Getting involved in ENT clinical research in the UK; how can the NIHRClinical Research Network help?Blackshaw, H.,* Philpott, C.,† Bhutta, M.F.,* Cooper, S.‡ & Schilder, A.G.M.**evidENT, Ear Institute, University College London, London, UK, †Norwich Medical School, University of East Anglia, Norwich, UK,‡NIHR Clinical Research Network Coordinating Centre, Leeds, UKClin. Otolaryngol. 2014, 39, 328–333Introduction to the National Institute for HealthResearchIn 2006, the Department of Health formed the NationalInstitute of Health Research (NIHR) to create an environ-ment for world class health research within the NationalHealth Service (NHS). Historically, research occurredmainly in teaching hospitals, with a lack of equal opportunityfor patients to participate in research and no overallnationwide framework to assist the conduct of researchwithin theNHS.With themission to ‘Improve the health andwealth of the nation through research’, the NIHR hastransformed clinical research in the United Kingdomthrough the establishment of the hugely successful ClinicalResearch Network (CRN) and the initiation of a nationalportfolio of studies, together providing the local infrastruc-ture to support clinical researchers in conducting high-quality research. This has led to an increased number ofhealthcare professionals and patients participating inresearch and the NHS being seen as an international leaderin clinical research.What is the NIHR?• TheNational Institute forHealth Research is a nationalorganisation operating within the NHS with themission to improve the health and wealth of thenation through research• It is led by the Chief Medical Officer Professor DameSally Davis• The overall annual budget is ring-fenced at 1% of theNHS budget (£1 billion)Academics, clinicians, industries and patients involved inENT clinical research may already be aware of the CRN andthe support they offer for the delivery of research. Equally,the CRN may be viewed by some as a familiar name, but avast and complex organisation of unknown capacity. Orpossibly, the CRN is a completely unknown entity. This briefpaper aimed to provide practical information to enable ENT,hearing and balance specialties to benefit from the researchinfrastructural support provided by the CRN. We will focuson the impact the network has had on recent ENT studies aswell as an introduction to the recognisable names behind thenetwork and the support it offers.What is the Clinical Research Network?• The CRN was set up by the NIHR to enable NHSpatients and health professionals across England toparticipate in high-quality relevant clinical research• The annual budget for the CRN is £286 m• The CRN provides a unique health service infrastruc-ture to support clinical research in the NHSWhere does ENT fit in the structure of the NIHR ClinicalResearch Network?The CRN comprises of 15 Local Clinical Research Networks(LCRNs) that cover the length and breadth of England(Fig. 1). Each LCRN delivers research across 30 clinicalspecialties including ENT. A national coordinating centreprovides central management for the network. Similarsystem exists within the devolved nations and detailsregarding those can be found at: http://www.cso.scot.nhs.uk/, http://www.nicrn.hscni.net/ and http://www.wales.nhs.uk/sites3/home.cfm?orgid=952.The NIHR CRN Portfolio, what is it and what are thebenefits?At the heart of the CRN’s activities is the NIHR CRNPortfolio. This consists of high-quality clinical researchstudies that are eligible for consideration for support fromthe CRN in England.The portfolio database captures research activity data andprovides analysis tools to facilitate active management ofcurrent studies, and the feasibility of future studies runwithin the CRN. Activity data from the portfolio are used to© 2014 John Wiley & Sons Ltd  Clinical Otolaryngology 39, 328–333328EDITORIALCOMMENTinform the allocation of NHS infrastructure for research(includingNHS support costs) and support the performancemanagement of the CRN.There have been over 90 observational and interventionalEar, Nose and Throat studies registered on the portfolio as itwas set up and over 30 of these are currently recruitingparticipants within the NHS (http://public.ukcrn.org.uk/search/). Clinical studies registered on the portfolio benefitfrom the CRN infrastructure that has been put in place toassist researchers to complete their research, including thefollowing:• Access to a local network of dedicated skilled researchsupport staff including research nurses and other alliedhealth professionals, who can help identify eligiblepatients, arrange consent to participate in the studyand monitor patients as they progress through thestudy• Support to ensure that a given study can be successfullyundertaken in theNHS including pharmacy, imaging andpathology services and the possibility of securing pro-tected time for NHS staff to conduct research• Provision of dedicated systems to assist researchers ingaining approvals to open their studies within the NHSquickly and efficiently (Coordinated System of Permis-sions, CSP). In the past, researchers had to make separatepermission applications to every trust, but the CRN hasrevolutionised this process through CSP. Researchersnow only enter their study details once, even on multisitestudies. The CRN then coordinates all the necessary NHSResearch and Development reviews at every participatingNHS Trust through CSP.• Practical help in identifying and recruiting patients ontoportfolio studies, so that researchers can be confident ofcompleting the study on time and with the target numberof participants required.• National monitoring of the monthly performance ofportfolio studies and the availability of local dedicatedENT, hearing and balance experts to assist with specialistknowledge to help recruit participants to studies(Table 1).All researchers with funded ENT research projectsshould therefore consider applying for portfolio inclusionto gain advantage of this support the CRN offers andbring this additional funding for research delivery intotheir trust.How can i get my ENT study adopted onto theportfolio?Both non-commercial (researcher-led) and commercial(industry-led) studies can register to be included in theportfolio. As the CRN is a government funded organi-sation, all studies in England must comply with theDepartment of Health established eligibility criteria forcommercial and non-commercial research to qualify forCRN support.123456789101415131211123456789101112131415NORTH EAST AND NORTH CUMBRIANORTH WEST COASTYORKSHIRE AND HUMBERGREATER MANCHESTEREAST MIDLANDSWEST MIDLANDSWEST OF ENGLANDTHAMES VALLEY AND SOUTH MIDLANDSEASTERNKENT, SURREY AND SUSSEXWESSEXSOUTH WEST PENINSULANORTH THAMESSOUTH LONDONNORTH WEST LONDONFig. 1. NIHR Local Clinical Research Networks in England.Table 1. Who is my ENT specialty local lead? Who can I contact for specialist advice?Local clinical research network (LCRN) ENT specialty local lead SpecialismEast Midlands Professor Deborah Hall AudiologyEastern Mr Carl Philpott Rhinology, Anterior skull baseGreater Manchester Mr Kevin Green OtologyNorth East and North Cumbria Mr Anirvan Banerjee OtologyNorth Thames Professor Anne Schilder Paediatric ENT, Clinical trials methodologyNorth West Coast Mr Adam Donne Paediatric ENTNorth West London Mr Taran Tatla Laryngology, Head and neckScotland Mr Kenneth MacKenzie LaryngologySouth London Ms Claire Hopkins Rhinology, Anterior skull baseThames Valley and South Midlands Mr James Ramsden Otology, Paediatric ENTYorkshire and Humber Mr Jaydip Ray Otology, Paediatric ENTEditorial Comment 329© 2014 John Wiley & Sons Ltd  Clinical Otolaryngology 39, 328–333Non-commercial studiesEligibility for inclusion is judged by experts within theCRN to ensure the research has been funded in opennational competition, appropriately peer-reviewed, is ofclear value to the NHS and fits within the needs andrealities of the NHS.Researchers completing their approval forms within theIntegrated Research System (IRAS) can choose on thefirst page of their IRAS application to have their projectassessed for CRN support and inclusion in the CRNPortfolio. If you choose to be considered for portfolioinclusion, you will be asked to complete and submit aCRN portfolio application form (PAF). Only one PAF isrequired for the entire research project from the lead site,where the Chief Investigator is based. Within 2 workingdays, you will receive confirmation that you can use theCoordinated System for Gaining NHS Permission (CSP)system through which you should complete andsubmit your Research and Development (R&D)application. The eligibility process runs in parallel tothe R&D checks and a decision on eligibly for the NIHRPortfolio will then be given within 30 days. In 2013/14,the median number of days to achieve NHS Permissionfor all study sites for all portfolio studies was 25 calendardays (http://www.crn.nihr.ac.uk/about-crn/our-perfor-mance/key-statistics-2/).Further information on the process can be found at:http://www.crn.nihr.ac.uk/can-help/funders-academics/gaining-nhs-permissions/the-csp-flowchart/).Commercial studiesThe CRN provides free support to help the life sciencesindustry to deliver high-quality research in the NHS. TheCRN’s priority is to proactively support the life sciencesindustry to deliver high-quality clinical research in the NHS,and to enable this, they have developed a range of freeservices and support tools around feasibility, set-up andperformance management.To be eligible for inclusion on the portfolio, commercialstudies (i.e. those which are industry-led and either fully orpartly industry supported)must be submitted to the networkvia an online system by a member of the sponsoringcompany or Clinical Research Organisation (CRO) for theassessment against the following eligibility criteria, asdefined by the Department of Health:• The studymustmeet the networks definition of ‘research’(further information can be found at the web link below).• The study must receive NHS Research Ethics Committeeapproval and NHS permission prior to initiation atindividual sites.Researchers wishing to introduce commercial companiesto the network should direct them to thewebsite http://www.crn.nihr.ac.uk/can-help/life-sciences-industry/. Companiescan submit their studies to the network at www.submitmy-study.nihr.ac.uk.Success story 1Established in October 2007, the Chronic RhinosinusitisEpidemiology Study (CRES) was run in ENT departments inEast Anglia. The study set out to recruit 1000 patients withchronic rhinosinusitis and 200 control subjects. The aimwasto investigate the medical, socio-economic, psychologicaland environmental factors that may influence the severity ofchronic rhinosinusitis and so address one of the researchobjectives of the European Position Paper on Rhinosinusitisand Nasal Polyps.1From 2007 to 2012, a total of 627 participants wererecruited at a rate of about 7 per month. Followingappointment at the University of East Anglia as a SeniorLecturer, Mr Carl Philpott (Eastern ENT local lead) usedfunding from the Anthony Long Trust to establish this as astudy eligible for inclusion on the portfolio.Adoption onto the portfolio inAugust 2012, together withthe support of the national ENT specialty, raised the profileof this study enabling it to be expanded to numerous sitesthroughout the United Kingdom (Fig. 2). The geographicdistribution of study participants included a wide range ofrural and urban areas of England and 2 of 3 devolved nations(Fig. 3). CRN support included provision of funding forresearch nurses or administrative input with the greatestnetwork input seen in the North East, resulting in recruit-Fig. 2. Number of open recruitment sites in the Chronic Rhinos-inusitis Epidemiology Study (CRES) following portfolio inclusionin August 2012.330 Editorial Comment© 2014 John Wiley & Sons Ltd  Clinical Otolaryngology 39, 328–333ment of the highest number of participants outside of EastAnglia. Overall, the number of study participants enteringthe study each month rose from the seven recruited inSeptember 2012 to a peak of 130 participants in August 2013(Fig. 4).With this successful UK-wide support, the study com-pleted recruitment of 1552 participants in September 2013,with 1480 complete data sets recorded in the final database.Study data are currently being analysed at the University ofEast Anglia and once published will provide further impetusfor research initiatives in rhinosinusitis in the UnitedKingdom.What is the NIHR ENT specialty?‘Specialties’ were set up by the NIHR CRN to providenational networks of topic-specific expertise. The aim of theENT specialty is to ensure the successful completion ofNIHR Portfolio research studies within ENT, hearing andbalance. Each specialty is formed of clinical researchers whorepresent their local network and act as local leads. Each locallead is able to provide guidance on the development andconduct of research within their region. In addition, theselocalmembers form a national network of expertise across allareas of healthcare.The ENT specialty currently has 11 local leads spanningthe United Kingdom with a wide range of subspecialtyexpertise (Table 1). The member currently appointed asnational lead for the ENT specialty is Professor AnneSchilder.Local leads, together with additional members represent-ing the devolved nations and important ENT stakeholders,meet three times a year to discuss national ENT research andthe support they can provide to portfolio studies. Forexample, they identify the portfolio studies that are strug-gling to recruit participants and those that need to open up toadditional sites. In addition, the specialty is able to providedetailed subspecialty clinical advice to researchers investi-gating a specific condition/area within ENT. Local leads areable to provide details of patient populations withintheir region, so promoting study opening within new NHSTrusts and enhancing the number of patients offered theopportunity to participate in research across the UnitedKingdom.The ENT specialty works to engage the wider ENTcommunity in the work of the CRN to raise awareness ofthe support the network provides. As a result, a coordinatednational message is being spread to researchers, ENTresearch initiatives are starting to broaden from localstudies to multicentre trials, and the proportion of openstudies on the portfolio recruiting the required number ofparticipants within the timescale of the funding hasimproved.The ENT specialty has also organised successful workshopsessions, open to the wider ENT community, with themessuch as Patient and Public Involvement (2012, 2014),Working with Industry (2013) and Developing ResearchQuestions and Prioritisation in collaboration with NETSCC2013).Success story 2The chief investigator of the Genetics of Otitis Mediastudy, Mr Mahmood Bhutta, believes the success of thisstudy is down to the network support he and his teamFig. 3. Geographical spread of recruitment sites for the ChronicRhinosinusitis Epidemiology Study (CRES).Fig. 4. Number of patients recruited to the Chronic RhinosinusitisEpidemiology Study (CRES) per month following portfolio inclu-sion in August 2012.Editorial Comment 331© 2014 John Wiley & Sons Ltd  Clinical Otolaryngology 39, 328–333received. Otitis media is known to be highly heritable, andhis study set out to discover candidate genetic polymor-phisms conferring susceptibility, through recruitment ofchildren having grommets inserted to treat chronic glueear.Power calculations showed that at least 900 affectedfamilies needed to be recruited to discover genes ofmoderaterelative risk, amounting to around 3500 individual partic-ipants. The original plan was to recruit from eight regionalhospitals in the Thames Valley area, but early recruitmentwas slow, and it transpired that unfortunately less than halfof participants who agreed to participate actually returnedtheir DNA.2 In the first 10 months of the study, an average ofonly nine families per month were successfully recruited, atrajectory that predicted that less than half of the recruitmenttarget would be reached in the 3–4 years allocated to thisstudy.Inclusion onto the portfolio transformed the study(Fig. 5). Funds were provided for a full-time researchnurse and a study administrator, and the study wasadvertised through the NIHR Portfolio website. Contactfrom research teams across the United Kingdom meantthe study rapidly expanded to include 36 centres (Fig. 6).In the last 6 months of 2013, the study was recruiting anaverage of 45 families per month. The study was extendedto recruit beyond the original sample size to enableanalysis of genotypes of lower relative risk and has nowrecruited over 1600 families (around 6000 individuals) tothe end of 2013, making this also the largest study in theworld investigating the genetics of otitis media. That is alldown to the support afforded through the CRN.Contact usThis article has outlined how the NIHR is supportingclinical research in the NHS through infrastructure,clinical networks and training. The success stories aregrowing and the pace and quality of research within ENTis increasing. To take advantage of the support anddelivery options available to researchers, we encourageENT researchers to contact the CRN via their local0102030405060708090+++++++++++++++++++++++++++++++++++++++++++++++++++++++++Fig. 5. Recruitment to the genetics of otitis media study April 2009 to December 2013.Fig. 6. Recruitment sites for the genetics of otitismedia study April2009 to December 2013.332 Editorial Comment© 2014 John Wiley & Sons Ltd  Clinical Otolaryngology 39, 328–333network, through the main NIHR CRN website, or via theENT specialty.How do I approach the CRN?• The NIHR CRN website http://www.crn.nihr.ac.uk/• Your local network (LCRN) http://www.crn.nihr.ac.uk/about_us• The ENT specialty http://www.crn.nihr.ac.uk/abou-t_us/ear_nose_throat/• The national ENT specialty lead a.schilder@ucl.ac.uk• The national ENT specialty administrator m.sim-monds@ucl.ac.uk• Your ENT specialty local lead (Table 1)Keypoints• TheNIHRCRN provides the infrastructure to supportclinical research in the NHS• ENT researchers can accessCRN support by registeringtheir studies onto the CRN Portfolio• Two recently completed ENT clinical studies haveattributed their success to the support they receivedfrom the NIHR CRNConflict of interestNone to declare.References1 Fokkens W.J., Lund V.J., Mullol J. et al. (2012) European positionpaper on rhinosinusitis and nasal polyps 2012.Rhinol. Suppl. 3, 1–2982 Bhutta M.F., Hobson L., Lambie J. et al. (2013) Alternativerecruitment strategies influence saliva sample return rates incommunity-based genetic association studies. Ann. Hum. Genet.77, 244–250© 2014 John Wiley & Sons Ltd  Clinical Otolaryngology 39, 328–333Editorial Comment 333

Getting involved in ENT clinical research in the UK; how can the NIHR Clinical Research Network help?

Abstract

Similar works

Full text

Available Versions

Crossref

University of East Anglia digital repository