1

TASC TAyside medical Science Centre

Research Site Capability Document 2012

2

TASC TAyside medical Science Centre

The Research of Today Is the Treatment of Tomorrow

• TASCprovidesresearchsupportservicesformedicalresearch.

• TASC’sproductistherobustdeliveryofethicalmedicalresearch ensuringthesafetyofallparticipants.

• Ourproductiscreatedbylocalresearchersorindustrypartnersand deliveredwiththeparticipationofthelocalTaysidepopulation.

TASC Components

ClinicalResearchFacilities(CRF’s)ClinicalResearchImagingFacilities(CRIF)DundeeEpidemiologyandBioStatisticsUnit(DEBU)EastofScotlandResearchEthicsService(EoSRES)HealthInfomaticsCentre(HIC)Research&DevelopmentOfficeResearchNurseServiceTaysideClinicalTrialsUnit(TCTU)TaysideTissueBank(TTB)

TASC Support Services

Approvals&SupportCostsCommercialResearchTeamFinanceGovernanceLegalMonitoringandPharmacovigilance

www.tasc-research.org.uk

twitter.com/tasc_research

www.facebook.com/TASC.Research

NHS RESEARCH SCOTLAND

3

Content

TaysideCommercialMetricsandHighlights 1

ResearchManagement/Coordination 2

ResearchSiteProfile 6

IRB/EthicsCommittee 13

StudyStartUpInformation 14

Monitoring 17

Recruitment 18

Pharmacy 18

TaysidePrevalenceData 20

DiseaseSpecificInformation 21

Research Site Capability Document 2012

4

Year 2009 2010 2011

FeasibilityReturns(InclusiveofCDAinworkingdays)

17.1 9.7 4.3

*R&DApprovalMetrics%Under30days

N/A 84% 85%

GenericReview(MeanWorkingDays) 8 5 2

LocalReview(MeanWorkDays) 20 11 13

*No.ofNewRecruits 148 346 354

*MedianWorkingDaysfromapprovaltoFSI

N/A 56 34

*OverallTargetRecruitmentVsActualRecruitment

N/A 53% 80%

Year Status Disease Area Type Achievements2009 COMPLETED Diabetes T2DM ToprecruiterintheUK2010 COMPLETED Diabetes T2DM GloballeadinFeb,MarchandApril

2010.Targetof10patientsreachedin14days.Alltenpatientsrandomised.

2010 COMPLETED Diabetes T2DM Firstpatientconsentedtotakeparton26/May/2010dayaftermanagementapproval

2010 COMPLETED Diabetes T2DM Targetof5,currently8screenedand7randomised.UKonlysite(36sites)SitehasbeenjointtopsiteforrandomisedpatientssinceMarch

2010 ONGOING Cardiovascular DAPTInterventionalCardiology

UKToprecruiter,EUfirstPatient

2010 ONGOING Cardiovascular CardiovascularHF Globalfirstpatient2010 COMPLETED Diabetes T2DM Globalfirstpatient2010 ONGOING Oncology MetastaticBreast

CancerGlobalfirstpatient

2010 ONGOING Diabetes T2DMCVOutcomes EUFirstpatient2010 COMPLETED Oncology NeuropathicPain UKfirstpatientandfirstUKsiteto

complete2010 ONGOING Cardiovascular CardiovascularAF 5thinUKrecruitmentoutof22sites2011 ONGOING Ageing&Health Interventional

NutritionalSupplement

RecruitmentTargetdeliveredwithin12weeks

2011 ONGOING Cardiovascular Cardiovascular-HF UKfirstpatient

Tayside Commercial Metrics Highlights

Tayside Commercial Highlights

*MetricstakenfromreportsgiventoCSO/LiSAB(ChiefScientistOfficeandLifescienceAdvisoryBoard)

5

Research Management/CoordinationTheTAysideMedicalScienceCentre(TASC)wasformallyestablishedonthe1stJanuary2010bycombiningtheestablishedresearchstrengthsoftheUniversityofDundee(UoD)withNHSTayside(NHST),andispartoftheeasternnodesofNHSResearchScotland(NRS)andHealthScienceScotland(HSS).

AkeyaimofTASCistoprovidetheinfrastructuretofacilitateresearchforallhealthprofessionalsandtopromoteastrongcultureofresearchwithintheNHS.TheTASCofficesarehousedwithinrefurbishedaccommodationonlevel3oftheoldNursingSchoolpremisesontheNinewellssite,co-locatedwiththeEastofScotlandEthicsService.

TASC Research Infrastructure

6

TASChasbroughttogether,withinasingleorganisationalframework,theexistingclinicalresearchmanagementfunctionsoftheUoDandNHST.

• TheTASCR&Dofficehasmanyrolessuchas:researchadvice,projectregistration,UoD&NHSSupportcostcalculationatfundingapplicationstage,genericandlocalreviewofresearchgovernanceissues,contracts,siteagreements,riskassessment,sponsorshipapproval,R&Dapproval.Pharmacovigilance,QAandGCPmonitoring.

• TheTaysideClinicalTrialsUnit,co-ordinatingallclinicaltrialsexpertiseinTayside,andsupervisingtheTaysideClinicalResearchFacilitieswhichofferfirst-classareasfortheconductofpatient-basedresearchandclinicaltrials

• TheClinicalResearchImagingFacility(CRIF),acustom-designedspacewhichhousesadvanced3TMRIandPET/CTscannerswithauniqueadjoininginterventionalsuite

• LaboratoriesandbiorepositoriessuchastheTaysideTissueBankwhichallowpatientderivedsamplestobeused(withpermission)toadvancemedicalresearch

• DundeeEpidemiologyandBiostatisticsUnitandtheHealthInformaticsCentre,offeringinternationallyrenownedexpertiseineHealthsolutionstogetherwithlinkageandanalysisoflargepatientdatabases

Cameron Glen BSc RICRHead of Business Development and Commercial ResearchTaysideMedicalScienceCentreNinewellsHospital&MedicalSchoolTASCResearch&DevelopmentOfficeResidencyBlock,Level3GeorgePirieWayDundee,ScotlandDD19SYUnitedKingdom

Direct Line+44(0)1382740455Mobile+44(0)7970786920Emailc.glen@dundee.ac.ukWebwww.tasc-research.org.uk/Industry

Please send all feasibilities, study amendments and study milestone/finance enquiries to the corresponding generic email addresses which are reviewed on a daily basis:

For feasibilities to:tascfeasibility.tayside@nhs.net

For study amendments to:tascamendments.tayside@nhs.net

For all study finance enquiries to:tascmilestones.tayside@nhs.net

Forallindustry sponsored studiestheCommercialResearchTeamactsasaninterfacebetweencommercialsponsors,theNHSandtheUniversity.

Research coordination within TASC

The central point of contact within the management organisation for all Industry led and collaborative studies

7

Organisation/site ProfileTherearecurrentlytwolevelsofserviceavailabletosponsors:

TASC Routine Service – As is service working to National Targets

Thecommercialteamhandlesallcontractsandfinancesforindustrysponsoredtrials.EachclinicaltrialwillhaveadedicatedR&Dofficerwhowillsupportstudiesfromstarttofinish.ThiswillbedeterminedoncethesponsorhasconfirmedwiththestudyteamandtheCommercialManagerthatthesitehasbeenselected.Thecommercialteamprovidessupportforprojectregistration;NHS&NHSSupportcostcalculation,genericandlocalreviewofresearchgovernanceissuesandobtainingNHSR&Dapproval.ThecommercialteamworkcloselywithPharmacy,Studyteams,ClinicalResearchFacilities,legalandfinanceteams.

TASC Fast Track Service – Delivering Enhanced start up times

ThefocusinNHSScotlandinrecentyearshasbeenplacedonimprovingapprovalstimelinesandprocessestoenableManagementApprovaltoProceedwithastudyinthebestpossibletime.Evenwiththisimprovement,itisrecognisedwithinTASCthatforsomeprojectsalevelofserviceoverandabovethestandardissometimesrequired.Thesemaybetimesensitiveprojectswhereby,forinstance,arapidprogressionthroughtheapprovalsprocessmightbeneededinorderthatastudymaystartinlinewithseasonaldiseaseincidence,ortheymaybeaneedforacceleratedstartupandapprovaltodeliveraspecificrecruitmenttarget.SuchsituationsrequireadditionalresourcetointerfacewithR&DandStudyteamsatsite.TASCarenowresourcedtoofferenhanced,“fasttrackservice”forsuchstudies/projects.

ThisserviceguaranteesthesponsortheservicesofanexperiencedResearchNurseFacilitatortospeedupStartUpandApprovalsprocess,focussingonSiteRecruitmentActionPlanning(SRAP)andtodeliverearlyrecruitmenttothestudy.ThisisoverandabovethededicatedstudyteamandattractsapremiumatR&DSetUpfeeandinthecostingofstudyactivityrelatedtorecruitment.WehavepartnerswhoarecontractuallyengagedinthisprocessandwouldurgeanysponsorswithprojectswhichmightbenefitfromthisapproachtodiscusstheirneedswiththeCommercialManagerasearlyaspossible.

Forallindustry led and collaborative studiestheCommercialManageristheinitialpointofcontact.TheCommercialManagerliaisescloselywiththeothersectionsofTASCsuchastheTASCBusinessDevelopment,TaysideClinicalTrialsUnit(TCTU),ClinicalResearchCentre,ClinicalResearchGovernanceandtheAcademicandNHSdepartmentstoco-ordinateamanagedresponsetoenquiriesfromexternalpartners.AnyresponsetoanindustrialpartnerwillconfirmfeasibilityofcarryingoutthestudyinTaysideandincludedetailsofthelocalresourcesrequiredtocarryoutthestudy(e.g.NHSstaffandfacilities),andaninitialbudget.ThecommercialmanagerwilllinkwiththeTASClegalgrouptoprepare/reviewthenecessarycontracts.Aworkinggrouphasbeendevelopedto

Service Levels Available to Sponsor

Staffing structure within the Commercial Research Team

Research Management/Co-ordination

8

manageinitialset-upactivitiesforindustrycollaborativeproposalsthisconsistsoftheCommercialManager,Governanceleads,ClinicalTrialsUnitlead,ClinicalTrialPharmacistandLegalLead.ThisworkinggroupidentifiesthenecessaryunitsandstaffwithinTASCtoco-ordinateastudy

TheCommercialManagermanagesateamincludingtwocommercialresearchadministrators(R&DOfficers),twoadministratorsupportofficersandtwocommercialresearchnursefacilitators;oneofthesepostsisfocusedonlinkingwithprimarycare.

T ays ide R &D Director

S nr R &D Manager

C ommercial Manager 1.0WT E

C ommercial Adminis trator

0.6WT E

C ommercial S upport O fficer

0.75WT E

C ommercial Adminis trator

0.6WT E

C ommercial S upport O fficer

1.0WT E

C ommercial F acilitator 1.0WT E

C ommercial F acilitator

(P rimary C are) 1.0 WT E

Allstaffinvolvedinmanagingandco-coordinatingCTIMPsareGCPtrained.Additionally,dependentonrole,staffwillalsobeGMPandG(C)LPtrainedandallstaffworktoPolicies,SOPsandworkinginstructions.Thecommercialteamhaveamixtureofexperienceallarequalifiedtodegreelevelwithbetween2–7yearsexperiencewithinclinicalresearch.TheteamhaveavarietyofexperiencesofworkinginthepharmaceuticalandCROindustriesaswellasexperiencewithinacademiaandtheNHS.

AriskassessmentisundertakenforeverystudytoassesswhetherTaysidecandeliverthestudywithintherequirementlaidoutbythesponsor.ThisinvolvesPI/CIcurrentandpastperformance,resourceandcapacityassessmentreviewedandcompetingtrials,andwhererecruitmentbecomesaproblem,weoffersupportfromtheteamtoenhanceit.AdditionalsupportisavailablefromTASC/TCTUtoensuretheclinicalresearchteamworkstotheappropriateregulatorystandards.Thissupporttakestheformofguidance,SOPsandtrainingthroughtohighlyexperiencedstaffresourcetoreviewrecruitmentproceduresanddiscussdatamanagementsystems.TheCI/PIanddesignatedtrialcoordinatorand/ortrialmanagerareprimarilyresponsibleforensuringthatstudyrecruitmentismet.OversightisprovidedbytheSponsorviaGCPmonitoringandtheCommercialResearchteamwithintheR&DOffice.Identificationofdifficultieswithrecruitmentarereviewedonaweeklybasis.Ifissuescontinuearecruitmentescalationprocessisfollowed.

Commercial Research Team experience and qualifications.

9

Tayside’sexcelsin5keyresearchareaswhichare:Diabetes, Cardiovascular Disease, Inflammation, Cancer Neuroscience

Theseareunderpinnedbyexcellencein:InformaticsImagingCommunity-based trials Genetics.

WehavealargeportfolioofPhase2-4studies,bothsponsoredandhosted,inTayside.Currently>30CTIMPsaresponsoredbyUOD-NHSTand~60studieshosted.TASCdoesconductanumberofPhaseIstudiesprimarilyincancer,diabetesandcardiovasculardisease.Inadditionwehave~100activecommercialclinicaltrialsinanextensiverangeoftherapyareaswithasignificantproportionofthemactiveinNationalPriorityareasofCancer,Stroke,andCHD.WehaveparticularstrengthandastrongperformanceheritageincommercialtrialsinOncology,CV,DiabetesandChildHealth.

RegulatoryandICHGCPcomplianceismanagedbytheResearchGovernancegroupwithinTASCwhichinvolvesGCPmonitoring.TheUniversityandNHShaverecentlyundergonesuccessfulMHRAGCPInspectionandcontinuestosupporthighqualitytrialswhichmeetregulatorystandards.

AllstaffworkinginCTIMPsarerequiredtocompleteGCPtraining,holdtraininglogsandaresubjecttocontinuoustraininginGCPviacertifiedattendanceatTASCworkshopsandseminars.

Out of the 14 Scottish Health Boards NHS Tayside consistently places in the top 3 in terms of recruitment performance to Industry sponsored clinical trials.

Recruitmentisviaamultifacetedapproachwhichincludesforexample(notexhaustive),NHSoutpatientclinics,multidisciplinarycareteamsexistingdiseaseregisters,networkandspecialitydatabases,researchregisters,primarycare(oftenviaGPpracticelists)andadverts.HoweverrecruitmentstrategieshaveevolvedinTaysidetoincludeeRecruitment(e.g.ViasoftwarecalledSARMAthatchecksthemedicalrecordofpatientsenteringconsultationsagainsttrialrecruitmentcriteriaandalertstheGPifamatchisfound),andothernovelsolutions.Incommercialprojectstheadditionalresourceofthecommercialresearchfacilitatorspecifictorecruitmentresponsibilitiescanbeputinplace.

TheR&DOffice,alongwithTCTU,isresponsibleforthemanagementofCTIMPs–frominitialearlyset-upthroughtoclose-out.

TASC Research Strengths

TASC Research Activity

TASC Patient Recruitment

Research Site Profile

10

TheTaysideClinicalTrialsUnit(TCTU)wasestablishedinOctober2008asacollaborationbetweentheUniversityofDundeeandNHSTaysidetodeliverexcellenceinthedesign,conductandgovernanceofclinicaltrials.TheTCTUcentralofficecomprisesclinicalresearchers,trialmanagers,statisticians,governancesupport,ITandadministrativestaff.

TCTUprovidessupporttoresearchersundertakingclinicaltrialsofinvestigationalmedicinalproducts(CTIMPs)andnon-CTIMPrandomisedcontrolledtrials.TCTUoffersinvestigatorsscientific,funding,technicalandITexpertisefromconceptionofthetrialthroughtoanalysisandreporting.Forexample,incollaborationwiththeDundeeEpidemiology&BiostatisticsUnit(seebelow),TCTUprovidesadviceonappropriatetrialdesign,samplesize/powerestimation,developmentofthestatisticalanalysisplan,statisticalanalysis,appropriatereportingofresults,collaborativeinputtofinalreportsandpeer-reviewedpapers.Achoiceofsupportservicesisavailabletoinvestigators,tailoredtothelevelrequired,rangingfromdatamanagementsystemsorstatisticalanalysisthroughtofulltrialdesignandmanagement.

InDecember2009,theTCTUbecameaProvisionalRegisteredClinicalTrialsUnitundertheUKCRCClinicalTrialsUnitRegistrationProcess,aschemedesignedtohelpimprovethequalityofavailableexpertisetocarryoutclinicaltrialsintheUK.TCTUjoinedanetworkofonly49registeredClinicalTrialsUnitsacrosstheUK.

ThereisaTASCResearchQualityManualwhichdescribestheTASCResearchQualityPolicyandobjectives.TheQualityManagementSystem(asystemofinternalandexternalmonitoringandauditing)isreviewedannuallybytheTASCQualityAssurance(QA)toensurethatitiseffectivelyoverseeingthatthedifferentgroupswithinTASCareconformingtotherequiredprinciplesandstandards.Areasofrecurringproblemsorwherepotentialimprovementscanbemadewillbehighlightedandappropriateactionstaken.IncollaborationwithTCTUtheHealthInformaticsCentre(HIC)strengthensthedatamanagementpackageprovidedbyTayside.TheTCTUcurrentlyhastwopart-time,SeniorClinicalTrialManagers(SCTMs).ThesemembersofstaffprovideoversightforprojectspecificTrialManagers/Co-coordinators.Ashighlyexperiencedmembersofstaff,theSCTMsareabletoadviseontheprotocoldesignandpreparation,generationofassociatedtrialdocumentationandtherecruitmentstrategyformulti-centreRCTs.TheSCTMsworkwiththeclinicalresearchteamwiththesubmissionsforethicalandregulatoryapprovaltogetherwiththemanagementofamendmentsrequiredduringthedurationofthestudy.

TheHealthInformaticsCentre(HIC)hasadedicateddata-entryunitandcanprovidestudyspecificdataentryforsinglesitestudiesuptointernational,multi-centreRCTs.DataentrycanbefrompaperCRFsorquestionnairesorweb-basedelectronicdatacollectionsystems.HICstaffcancreateGCPcompliantin-housedatacollectionsystemsaswellasworktoonesprovidedbyanexternalsponsor.ThecostofdataentryisagreedwiththeSponsor/funderonacasebycasebasis

Tayside Clinical Trials Unit

11

Health Informatics Centre (HIC)

TheHealthInformaticsCentre(HIC)isapartnershipbetweentheUniversityofDundee,NHSTaysideandNHSFifeandprovidesresearchers,thoseworkingonqualityimprovementandothers,withlinked,anonymiseddatatohelpthemanswerquestionsabouthealth,theuseofdrugs,NHSservicesandpatientsafety.HICholdsdataaboutthewholepopulationofTayside,totalling400,000people.HIChasalsoexpandedtoholdFifedata,doublingcoverageto800,000,16%oftheScottishpopulation,allowingsuchprojectsasHEARTSandDARTStotakeplacewhereprimarycareandsecondarycareresearchersworkintandem.WeplantoextendthiscapabilitytothepopulationofForthValleyHealthBoardwhichasrecentlybeenaddedtotheEastRegionofScotlandcoveredbyTASC.

HIC,incollaborationwiththeDundeeEpidemiology&BiostatisticsUnit(DEBU),(www.dundee.ac.uk/medschool/debu)offersacomprehensivepackageofservicesthroughitsclosecollaborationwithstatisticians,cliniciansandresearchers.DEBUisagroupofbiostatisticiansandepidemiologists,ledbyPeterDonnan,ProfessorofEpidemiology&Biostatistics,whichprovidescollaborativeinputfordesign,andanalysistonationalandregionaltrialsaswellasobservationalstudiesin,forexample,pharmacoepidemiology,andgeneticstudiesincollaborationwiththeCentreforPharmacogeneticsandPharmacogenomics(MRC,Wellcome,CSO,andPharmaceuticalindustry-funded).

LaboratoryAuditor–broadscientificbackgroundinscienceandclinicallaboratoriesinuniversityandNHSfacilities(BSC,MSc,PhD).Training:HealthProtectionAgencytrainingcourse-“Internalqualityauditintheclinicalpathologylaboratory”(2009)andongoingin-housetrainingfromNHSlabstaffatNinewellsHospital”.AlsoGLPandGCLPtrained.

QAManager–MemberoftheBritishResearchAssociationofResearchQuality(BARQA).Training:BARQAcourse“GCPAuditing–Principles&Practice”(2010).AlsoGCPandGMP.

Wehaveonestudycoordinatorperresearchgroup,ineachofthemaingroupingsasabove,howevertheseseniorTrialCoordinatorsaresupportedbyteamsofresearchnurses.IntheClinicalResearchCentrethereare8trainedresearchnurses,withafurther17inthesatelliteFacilities(CRFs).

Eachteamisledbyaseniorresearchnursewithseveralyears(some>10)researchexperienceandspecialistclinicalexperienceinaparticulararea,e.g.cardiovascular,oncology,diabetes,paediatrics.Thenumberofstudiesthateachnurseworksonatanyonetimedependsonthesizeandcomplexityofthestudies,howevereachstudywillhaveanamedResearchNurseCoordinatorresponsiblefortheoverallcoordination,liaisonwiththePIandsponsor,andsupervisionofothermembersofthestudyteame.g.supportresearchnurses,technician,datamanagersadminstaff.Atleastonesupportnursewillalsobeallocatedtoeachstudyensuringcompletecover,andforlargeorcomplexstudies,theteammayincludeseveralresearchnurses,sometimesworkingacrossTayside,toensurethatrecruitmenttargetsaremetandqualitystandardsmaintained.

Informatics Expertise

TASC Study Coordinators

12

AllresearchnursesaretrainedinGCP,clinical,researchandstudyspecificprocessesandprocedures,andtheirresponsibilitiesineachstudyareclearlydefinedinthedelegationlogs.Additionalsupportcanbeputinplaceviathecommercialresearchnursefacilitator.Particularlyrelatingtostartupandrecruitmentforselectedstudies.

Clinical Research Centre (CRC) and Facilities

TheCRCisamajordevelopmentfortheUniversityofDundeeandNHSTayside,providingstate-of-the-artfacilitiesandadedicated,professionalinfrastructuretopromoteandfacilitatehighqualityclinicalresearchandexperimentalmedicinethroughoutTayside.OpenedinJuly2008byNicolaSturgeon,CabinetSecretaryforHealthandWellbeing,thepurpose-built,fullyequippedcentreprovidesaparticipant-focusedenvironmentthatincludesoutpatientandspecialistinvestigationareas,auniqueimagingsuite,aswellasadministrationandtrainingfacilities.LocatedatNinewellsHospitalandMedicalSchool,theCRCisfullyintegratedwithNHSexistingfacilitiesandservicesandisacollaborativepartnerwithTaysideClinicalTrialsUnitwithintheTaysideMedicalSciencesCentre.AdedicatedteamofskilledNHSTaysideandUniversityofDundeestaffworkhand-in-handtosupportourresearchersinconductingclinicaltrials(allphases).

WiththeCRCformingthehubclinicalresearchfacility,themanagementandgovernanceisrolledouttoanumberofsatellitefacilitiesincludingTheInstituteforCardiovascularResearch(TICR)clinicalrooms,TaysideChildren’sClinicalResearchFacilityandtheGannochyTrustClinicalResearchSuiteatPerthRoyalInfirmary,toofferhighquality,GCP-compliantclinicaltrialstopatientsacrossTayside.TheAcademic/ClinicalLeadsforeachofthesatellitesaresupportedbytheCRCFacilitiesManagementTeam,providinganeffectiveandefficientoperationalframeworkwithinwhichclinicalresearchstudiesareconductedsafelyandtothehigheststandardsofGCPandresearchgovernance.

TheClinicalResearchImagingFacility(CRIF)isajointinitiativebyNHSTaysideandtheUniversityofDundeetodrawtogetherclinicalresearchimagingcapabilityacrossTayside.Thisallowsimprovedcoordinationofexistingresourcesandenhancedcommunicationbetweenresearchersusingimagingtechniquesacrosstheregion.Researchactivityisfocussedaroundthefacilitiesbasedwithinthepurpose-builtCRCBuildingatNinewellsHospital.Auniquefeatureofthisfacilityistheabilitytousetheequipmentnotonlytoimagebutalsototreatpatientsusingimageguidedinterventions.

ThelowerleveloftheCRChostsaPET/CTscannerdedicated50%forresearchanda3TMRIscannerdedicated100%toresearch,staffedbytrainedNHSDiagnosticImagingstaff.Theareaalsoincludesaspaceforpharmaceuticalpreparation,patientchangingareasandadedicatedimageanalysisarea,capableofsupportingupto10people.

TASC Clinical Research Facilities

TASC Clinical Research Imaging Facilities

13

TASC Data Entry

Quality Assurance to review CRF

TASC Disease indications for Clinical Trials

TASC Sophisticated clinical techniques

Acombinationof4x1.5Tand1x3TMRI,a128slicePETCTand4further64sliceCTunitsacrossNHSandUoDfacilitiesunderTASCImagingofferthefullrangeofresearchimagingtechniquesavailabletoday,includingcardiovascular(cardiacperfusion),neurosciences(spectroscopy),oncology(wholebodydiffusion)applications

AdedicatedNHSdepartmentofNuclearMedicinesupportscommercialandnoncommercialstudiesrequiringthislevelofimagingandassessment

CardiovascularPhysiology:FMD,ECHO,MRI,iontophoresis,venousendotheliumbiopsy,biomarkers,endothelialcellfunctionandEndoPAT.

TASCemploysdedicateddatamanagementstaffinTCTU,Oncology,Haemato-oncologyandDiabetesResearchTeams.ThisresourcesupportstheclinicalresearchteamsinmanagingdataentrytoalargeandevolvingportfolioofCommercialandNonCommercialTrials

DataManagersareanintegratedpartoftherespectivestudyteamsTCTUSeniorTrialManagers,TCTUDataManagersandtrialpersonnelestablishthemostappropriatedatamanagementsystemandagreeprocessestoensuredataarecollectedandstoredinthemostappropriatewayandtoagreedtimelines.

QAisanintegratedcomponentoftheTASCinfrastructurewhichsupportsallcommercialandnoncommercialtrials.Wearehappytoandhaveexperienceof,collaboratingwithindustry/sponsorQAstructures.

Cancer, Cardiovascular, Diabetes, Inflammation, Neuroscience supported by Informatics, Imaging, Community and genetics. Specific sub-areas include paediatrics.

Taysiderecorded114trialsontheNIHRPortfoliodatabase,returned106trialsontheMHRADossier,andcurrentlyhostsover100trialsIndustryledstudies.WealsohavefurtherexpertiseinInformatics.

InformaticsTherehasbeenmajordevelopmentofcapacityforhealthinformaticsinDundeeoverthelastfiveyearswiththedevelopmentoftheHealthInformaticsCentre(HIC).TheinternationallyrenownedDiabetesAuditandResearchinTaysideScotland(DARTS)programme,afirstinthefieldofpatientdatalinkage,pilotedthewayfortherecentinvestmentbytheWelcomeTrustthroughtheScottishHealthInformaticsProgramme(SHIP)programme.ThisofferssubstantialopportunitytocarryoutmoredetailedpopulationstudiesinrelationtoCVprescribing,riskfactorsandoutcomes.TheseopportunitiesplaceDundeeinauniquepositiontobuildonitsreputationforinnovativeCVepidemiologystudies.RecentdevelopmentshaveincludedtheinterrogationoftheCARDsstudydatabasetoidentifythefactorsthatinfluencestatinresponseinpatientswithdiabetes(Colhoun),andthefollow-upof20,000subjectsfromthe15yearoldScottishHealthyHeartStudy.

14

TheScottishHeartHealthExtendedCohortinvolvesthefollow-upof18thousandmenandwomenrecruitedintoriskfactorandlifestylesurveysinthemiddle1980sto1990s.Thereportontheeightyearfollow-upofmorbidityandmortalitywonthenationalBUPAawardforepidemiologyin1996.Thestudynowhas16yearsoffollow-upinvolving3,405deaths,1,234ofthemCVand739fromcoronarydisease.Morbiditydatainvolves100,000hospitalepisodesunderanalysis.TheUnitalsohasdatawithfollow-uppendingon16,000coronaryeventsinGlasgowoccurringin1985-96,andalsohasaccesstothedatabaseofthewholeWHOMONICAProjectonriskfactorsandcoronaryandstrokeeventsin38populationsin21countries.

Genetics and genetic epidemiologyDundeeleadsinthepopulationmedicalinformaticsfieldwithauniqueresourcefortheinvestigationofgeneticinfluencesondiseasesusceptibility/progressionandresponsetotreatment.LargescaleDNAcollectionsareavailablefrommanystudies,withapproximately8%ofthetotalTaysidepopulationbeingconsentedandrecruitedforgeneticstudies,thelargestofwhichbeingGo-DARTswithDNAfromover18,000individuals.TASCFORCE(n=15,000subjectsoncompletion)hasaformalBiobankwhichlinkswithotherlocalpopulationsamples(andfromelsewhereinScotland)throughtheGenerationScotlandcollaboration.Dundeeistherepositoryforthe3,800DNAsamplesfromTRACERA(BHFfunded),POPADAD,andGo-DARTS,allstoredinthestate-of-the-artTaysideTissueBankandPharmacogeneticsCentre.ThisgroupinghasrecentlyreceivedmajorEUfundingininvestigatingthegenomicbiomarkersofcardiovasculardiseaseinGo-DARTS(EUSUMMIT)andingeneticdeterminantsofoutcomeinHeartFailure(BIOSTAT-CHF).RecentdiscoveriesincludetheroleoftheobesitygeneFTOinthedevelopmentofcardiovasculardiseaseanditsprimaryroleindeterminingeatingbehaviour.

Taysidehaspioneeredtheuseofhealthinformaticsindetermininggenesthataffectbothefficacyandthesideeffectsoflipidloweringdrugs,andoncommonlyuseddiabetestreatmentssuchassulphonylureas,metforminandthethiazolidinediones,establishingproofofprincipleofpopulationpharmacogeneticsincommontype2diabetes.GenomewideassociationstudiesoftheGo-DARTSpopulation,aspartoftheWellcomeTrustcasecontrolconsortium2haveidentifiedanovelvariantassociatedwithmetforminresponse,whichhasachievedgenomewidesignificanceandreplicatedintwoindependentdatasets.Thegroupareabouttoundertakepharmacogeneticstudiesofandanti-hypertensives(bothforefficacyandadverseeffect)e.g.bloodpressurereductiontoACEinhibitorscanbedefinedinexcessof3000individualswithdiabetes.Colleagueshavesuccessfullydevelopedatechniqueofvenousendothelialsamplingforglobaltranscriptomics.Geneexpressionpathwayanalysisoftheseendothelialcellshashighlightedsomepotentialimportantpathwaysinthepathogenesisofatherosclerosis.

15

MHRA Inspections

Phase 1 Capabilities

Faculty Engagement with major Pharmaceutical Companies

UniversityofDundeeandNHSTaysidehaveundergonetwostatutoryGCPinspections.

2009UniversityofDundee

2011NHSTaysideandfollowupofUniversityofDundeefrom2009

TASCClinicalResearchCentreandotherresearchfacilitieswithinthehospitalhavebeddedcapacityforovernightphase1clinicaltrials

InparticularthesitehasexperienceinPhase1ClinicalStudiesinoncologypatients,(notablyatPh1b),andthereisevolvingexperienceinlatephase1biosimilarsforexample,inflammatorydisease,Haemato-OncologyandOncology

Theclinicalresearchcentreonsitehasasecuredbeddedareawithcapacityandresourcetomanage4-6in-patientsinappropriatePhase1diseaseRCT’s.ThecentreisnotcurrentlyaccreditedbytheMHRAforPhase1HealthyVolunteerprojects.

Manyofourfacultyareinvitedtolectureallovertheworld.Allconflictsofinterestdeclared.

16

IRB/Ethics CommitteeEthics Committee

Ethics Approval Timelines

Future internal process improvements

Training for Ethic Committee Members

Accreditation

Audit

Regulatory submissions

OurEthicsCommittee,(below),formpartofthenational,(NRES),centralethicsfacility

Thereare3ResearchEthicsCommittees(REC)withintheEastofScotland(EoSRES).TheFife&ForthValleyREChasIRBstatusisaType3committee,aflaggedPaediatriccommitteeandIRBregistered.TaysideRECBisaflaggedTissueBankcommittee.

Theaveragereviewtargetstimesare30-35days.Currentlyweareachieving,<30daysfromreceiptofacompleteddocumentset

WeareworkingwiththeChiefScientistOffice(CSO)andNationalResearchEthicsService(NRES)withregardstotimelinesetc.proportionatereviewiscurrentlybeingpilotedintwocentresinEngland.Allclinicalresearchstudies,includingCTIMPs,arereviewedanddevelopedbyaResearchGovernanceManagerpriortoreceivingSponsorshipapproval.ThisensuresthatnoapplicationsaremadewithoutaqualityreviewbySponsorandthatallstudydocumentationisofahighqualityandunlikelytoreceiveanegativeopinionfromREC.CoresupportandadviceisalsoavailablefromTASCstaffexperiencedinthedesignofprotocolsandassociatedtrialdocumentation,suchasCRFs,PIS,consentformsetc.TheTASCstaffareavailabletoworkwithclinicalresearchteamstoensurethedocumentationreviewedbytheRECisofashighastandardaspossiblesodecreasinganypotentialdelaysintheapprovalprocess.

EoSRESrunsanannualtrainingdayforcommitteemembers.AllcommitteememberscanattendNREStrainingdayswhicharewidelypromoted.TheScientificOfficerensuresthatmandatorytrainingforcommitteemembersisundertaken.MemberstrainingfilesareuploadedontotheResearchEthicsDatabase(RED),copiesofcertificatesofattendanceareheldwithintheMembersfilewithintheEoSRESoffice.

AllthreecommitteeshavefullaccreditationbyNRES,whichisundertakenonathreeyearlybasis,theScientificOfficercompletesaqualitycontrolchecklistforNRESforeachcommitteeonasixmonthlybasis.EoSRESrecentlytookpartinapilotauditofRECcentresbyNRES.

NREScontactsEoSRESwhenanauditisdue.Thelastauditwascompletedonthe22ndSeptember2010.

TheIntegratedResearchApplication(IRAS)formhasbeendesignedforsubmissionstotakeplaceinparallel.Itisnormalpracticeforregulatory,ECandNHSR&DManagementapprovaltooccurinparallel.AllapplicationsforethicalreviewarecompletedonIRAS

17

Commercial Research Services NHSR&DapprovalrunsinparallelwithIRB/Ethics.R&DApprovalisnotgivenuntilallchecksandapprovalsareinplace,includingMHRA.

TheTASCCommercialResearchTeamfollowstheNRSR&DProcessforallsingleandmulticentreclinicaltrials.

WecontractbyusingthestandardandnationallynegotiatedmCTA(Scotland)

WecoststudiesbyusingthestandardandnationallynegotiatedNIHRIndustrycostingmodelusingtheScottishPBR1.2multiplier.

85%ofstudiesareapprovedwithin30days.

NHS Research ScotlandStandard set up fees – Industry Led TrialsApril 2012

Study Start Up Information

R&D Fee AsperNIHRIndustryCostingModel

Research Site

Phase 1/2

Phase 3/4

Registry/Questionnaire Type Studies

CI Involvement

(ToincludeLab,Radiology&Researchteamfee)

£1500orhigherdependantonintensity/involvement

£1000setupfee

£500

Tobenegotiateddependantonintensity/involvement

Pharmacy AsperNIHRIndustryCostingModel

ARSAC £500perapplication

Archiving Archiving£300foronebox1.4cubicfeetfor15years

Travel Car-45pamileTaxi-Anonymisedreceipts

Refreshments £2.50to£5.00pervisit

Additional GMTrials£500

18

TASChaveprovidedresourcesforanumberofmajorclinicaltrialse.g.POPADAD,SSTEP,TRACERA,SCOT,FAST,ScottishFamilyHealthStudy.

Currentlywearerunning~100industryledstudies,approving30–40newstudiesayear.WebelievethatwehavethecapacitytoconductmanymorestudieswithinTayside.

ThroughdelegationlogandmandatoryGCPtraining.AllPIsarecognisantoftheirstatutoryresponsibilitiesforoversight,andthisisauditedbyteamsofinhousemonitorsforNonCommercialtrials,andCROs/SponsormonitorsforCommercialTrials.StandardOperatingProcedureswithsubordinateWorkingInstructionsareinplacetosupportandinformclinicalresearcherstomeetregulatoryrequirementsandtoensurealltrial/studydocumentsarecompleted,currentandadheredto.Alsonowprovidingmonitoringof‘highrisk’CTIMPsviaTASCmonitorsofhostedstudies.ThePharmacovigilanceSectionwithinTASCisprimarilyconcernedwithsponsoredstudies.

TaysideTissueBankandlocalstoragesites-20and-80freezersavailable.

TaysidestudiesanumberofOrphandiseasesvizcleftpalate,systemicsclerosis,criticallimbischemia

Investigators(PrincipalandSub)areavailable25–30daysamonthtoseesubjects.

Dependingontheneedsofthestudy.Frequentlypatientsareseentosuittheirworkingpractices,andsomeunitse.g.theAsthmaandAllergyResearchGroup(AARG)facilitiesprovidetestsafterhourse.g.CRCscanners

CASE NOTESClinicalcasenotesformthebasisof“sourcedocuments”andarestored,maintainedandarchivedinlinewithprevailingNHSScotlandandNHSTaysideGovernanceguidance.Whererequired,underthepremiseofanexecutedClinicalTrialAgreement,thesecasenotescanbearchivedforsuchlongerperiodsspecifiedinthecontractatcosttothesponsor/CRO.

CRF’s and Study Files and DocumentsUndertheaegisofICH-GCPthestorageandmaintenanceoftheCRF’sISF,IDBandotherstudyrelateddocumentationistheresponsibilityofthePI,delegatedunderanappropriatelycompletedandsigneddelegationtogtorelevantstudypersonnelincludingDatamanagerand/orResearchNurse.ThecostsandtermofsucharchivingisagreedandincludedintheexecutedmCTA.ThereiscurrentlyNOcentralisedEPR,(ElectronicPatientRecord)system.

Trial Capacity

PI oversight for safety and protocol adherence

Freezer Storage

Orphan Disease Experience

Investigator Availability

Evening and weekend hours for subject visits

Clinical notes and source documentation maintenance

Protection of Sponsor Intellectual Property.

19

Consenting patients, how we manage subjects who are:• Illiterate• Minors/Children • Children of minors• Require witnesses e.g. vulnerable populations

Confidentialdisclosureagreementsignedatthebeginningoftheproject.AllclinicalresearchwithanexternalSponsorissubjecttoaclinicaltrialagreementwhichcontainsspecifictermsrelatingtoIPR.ResearchersaremadeawareofanyspecifictermsandconditionsrelatingtoIPRhighlightedintheclinicaltrialagreement.Regularstafftrainingisprovidedtostaffwithrespecttotheownership,identification,protectionandcommercializationofintellectualproperty.WellestablishedsystemsareinplacetonotifytheSponsorifanyIPRisgeneratedasaresultoftheclinicaltrial.

AllsuchpatientsareprotectedbylawandhavespecificrequirementsforconsenttowhichTaysideadheres.NHSTaysideClinicalPolicyonConsent,GCPandRGG.

ResearchteamsfollowprescribednationalguidanceandwehavePaediatrictrainedresearchnursesandMedicineforChildren’sNetwork.

Allstudiesofthistypemustbeapprovedbyspecialistresearchethicscommittee(ScotlandRECA)

20

TheUniversityofDundeeandNHSTaysidehaveimplementedasetof65StandardOperatingProcedures(SOPs)foruseinClinicalTrialsusingInvestigativeMedicinalProducts(CTIMPs).AlsoPolicyonPharmacovigilanceandIMPAccountability.

TheSOPscanbefoundontheTASCwebsiteusingthefollowinglink;http://www.tasc-research.org.uk/SOPs

TASCemploysaClinicalTrialOperationsManager(CTOM)and3fulltimeclinicaltrialmonitorswhoperformmonitoringvisitsforTASCsponsoredandhostedCTIMPs.Thelevelofmonitoringforindividualtrialsisdeterminedbyadetailedriskassessmentandamonitoringplanisproducedwhichdocumentsthetypeandnumberofmonitoringvisitsrequired.

Alsonowdoingauditandmonitoringofhostedstudies.TheCTOMalsomanagesGCPbreachesforsponsoredandhostedstudies.

NHSTaysideandtheUniversityofDundeeprovidesecureandrobustITfacilitiesforstaff,whichareunderpinnedbyITpoliciesandcodesofpractice.ITsupportisprovidedbyadedicatedhelpdesk.Unreliableinternetconnectionsarenotaproblem.TCTUserversarehostedbytheDivisionofClinical&PopulationSciencesandEducationITstaff,whoalsosupportallofHIC’sservers.HardwarehasUPSprotection.Allserverssubjecttoback-upandemergencyrecovery.

TASCLabQAmanagerforlabsandsamples–inconcertwithTTBandNHSlabs.Biologicalsamplescanbecollectedasbothpartofroutineclinicalcareandasandwhendictatedbythestudyprotocol.Thecollectionandprocessingofbiologicalsamplesiscarriedoutbytrainedstafffollowingdocumentedprocedures.

TaysidewashosttothefirstUKstudyofgenetherapyforPeripheralArterialDisease,andhaverecentlybeenpartytoanothersuchtrial.BiologicsfordiseasessuchasRAareregularlystudied.TheexportofbiologicalsamplesissubjecttoapprovalsfromRECandotherauthorizedcommittees,e.g.TaysideTissuebank.

TASC SOPs

TASC Monitoring

TASC IT

Biological Samples

Monitoring

21

Databases

Advertising methods

TASC hospital network for recruitment

Recruitment Strategies

TASChasanumberofspecialisedareas.ACSOfundedprojectledbytheDivisionofClinical&PopulationSciencesandEducationiscreatingademonstratorforanationaldatabasecalledSHAREofupto1millionScottishResidentsindividualsinterestedinparticipatinginresearch.

Radioandnewspapers,salaryslips,posters.Alleffective.Newspapersmostproductivebutrequiremostfiltering.

NHSTayside–PerthRoyalInfirmaryandStracathroHospitalNHSFife–VictoriaInfirmaryandQueenMargaretHospital,StrathedenHospitalNHSForthValley–FalkirkRoyalInfirmaryandStirlingRoyalInfirmary

PI’slinkwithcolleaguesfromPrimarycare,acuteservicesandotherdepartmentswhenrequired.

Areusuallydefinedinprotocol.Iftheprojectisindustrysponsoredarecruitmentmanagementplanisdevelopedincollaborationwiththestudyteam.StudyteamdeveloprecruitmentplanwithsupportfromCRCandTCTUmembersofstaffwhereappropriateIftheclinicalresearchteamexperiencesdifficultiesmeetingitsrecruitmenttarget,theR&Dofficewillreviewandassesswhetheranyadditionalsupportisrequired.

Recruitment

PharmacyPharmacy Overview OnsitewithinNinewellsHospitalinadditionwehavesatellite

pharmacieswiththeClinicalResearchCentreandinPerthClinicalResearchCentre.

• Dedicateddrugstorageareaforinvestigationalproduct• Refrigeratedspacetostoreinvestigationalproduct• Lockedareaforinvestigationalproductsupplies• OnsiteExtemporaneousPreparationpharmacycapabilities(Limitedbyworkloadandstaffavailability)

DedicatedClinicalTrialsPharmacyteam-0.6FTEPharmacist,0.5FTEPharmacyTechnicianand1.0FTEpharmacyassistant.Additionalasepticstaffavailableasandwhenrequired.Additionalresourcefrompharmacycanbemadeavailabledependentonthecomplexitiesofstudies.

22

Adedicatedtrialcoordinator(or%FTE)toworksolelyonfacilitatingrecruitmenttoIndustrytrialswouldsignificantlyenhancerecruitment,asithasdoneforothercompanies.ThismemberofstaffwouldbebasedwithinTASCandthereforehaveaccesstothecombinedexpertiseoftheexistingSeniorClinicalTrialsManagers,researchnursesandtrainingprogram.

Dedicatedsecure,offsitearchivingfacilitiesprovidedbyaprivatecompany.TASChasSOPscoveringthestorage,retrievalanddestructionoftrialdocumentationbasedontherequirementsoftheSponsor.Off-sitearchivingprovidedforSponsoredstudies.Forexternalsponsors,tobeagreedinaCTA.

1xQAManager.PVoverseenbyCTOMPVMonitor.PreparationforGCPinspectionsliesprimarilywithCTOMinconcertwithanMHRAWG.

TASCwillprovideadviceandsupporttoinvestigatorsinpreparationforinspection.Adesignatedpersonwillberesponsibleforliaisingwiththeinspectorstoensurethecoherentcommunicationonmattersrelatingtotheinspectionandinformingallrelevantinternalstaffasearlyaspossibletogivethemtimetoprepareforinspection.StaffwillbegiventrainingandtheopportunitytoraiseanyconcernsaboutinspectionissueswithTASC.TASCwillalsohelpstafftohavetrialdocumentationinorder.

ThisismanagedonbehalfofTCTUbytheDivisionofClinical&PopulationSciencesandEducation’sITstaffasperTCTU’sSOPforback-upandrecovery.Theabilitytorecoverback-upsisregularlytested.

AnylicensesorMTAswouldneedtobeputinplace.Forresearchpurposes,researchgovernanceprocesseswouldneedtobesatisfiede.g.appropriateethicscommitteeapproval.Otherregulationsapplyto,forexample,transplantation.

Future Infrastructure Resource Needs

Record Storage and Archiving

Quality Assurance

Business Continuity & Disaster Recovery Plan

The transfer of human samples

Other

23

TASCwouldbeveryinterestedincreatingtheappropriatestrategicpartnerships.WecurrentlyhaveserviceagreementswithanumberofthemajorCRO’sandPharmaceuticalcompanies.

ForsponsorswhopreferanacceleratedserviceanadditionalservicelevelcanbeaccommodatedtheTASCFastTrackService.Thisservice,agreedandcosted“upfront”orwithinaMasterServiceAgreement,caninclude(notexhaustive),feasibility,SSVfacilitation,SRAPplanningandcoordination,essentialdocumentcollationandotherstartupprocessesincludinginitiationvisitandenhancedfocusonrecruitment.

2012Openingofapurposebuiltstateoftheartautomatedmultidisciplinaryfacility

2012Openingofpurposebuiltstateoftheartnuclearmedicineunit

2011OpeningofpurposebuiltstateoftheartAssistedFertilityUnit

InstituteofMedicalScienceandTechnology(IMSAT)www.imsat.org

InstituteofMotionAnalysis&Research(IMAR)TaysideOrthopaedicRehabilitationTechnology(TORT)Centre

http://www.dundee.ac.uk/orthopaedics

TheImaginggroupprovidesaccesstostateoftheartMRI,CTandPET.Inthecaseofcardiovascularandotherdiseases(cancer,etc.),thesemodalitiescanprovidemeasuresofmetabolism,bloodflow,perfusion,arterialstenosesinrelationtoCAD,PAD,strokeandrenalarterydisease.Anovelmeasureofwholebodyatheromaquantificationhasbeendeveloped,alongwithothernovelMRImarkersofCVrisk.ThisdedicatedResearchImagingSuite,launchedin2008asa£15millionUniversity/NHSTaysidepartnership,isastate-of-the-arthubfacilityfortheconductofpatient-basedresearchandclinicaltrialsofallphases.Thissuitecontainsatopoftherange3TMRIscannerandalsoatopofthelinemCT-128PET/CTscannerwithintegralinterventionalcapability.Uniquelyplacedbetweenthetwomodalitiesisanoperating/interventionroomthatpermitsusingthesescannersbefore,during,orafteranystandardsurgeryorintervention.Dundeeistheonlyplaceworldwideofferingsophisticatedscanningintegratedwithanoperatingtheatre.Thisprovidesadistinctivepotentialforapproachesthatrequirebringingarangeoftechniquestogetherforpatientandresearchbenefitwithinastate-of-the-artsetting.Forinstance,opportunitiesinnovelimplantsandimageguidedinterventions(includingwithrobots)arebeingdevelopedandvalidatedinassociationwithDundee’sInstituteofMedicalScienceandTechnology(www.imsat.org)forvascularstents,inferiorvenacavalfilters,MRIguidedatrialseptaloccluders,biopsiesandablations,etc.

ResearchdedicatedfacilitiesarecomplementedbyexistingNHSfacilitiesinMRI,CT,NuclearMedicine,ultrasoundandX-ray:allofthesehavethecapacitytosupportresearch,andmanyhavealreadybeeninvolvedinavarietyofprojects.

Future Collaborations

Future Infrastructure Developments

24

All practice contract types Practices with reportable QOF dataQOF register2 Practice count Combined list size5 Practice

countList size of practices5

Patients on this QOF register

Raw prevalence rate6

inQOF3 Allpractices4 inQOF Allpractices (per100patients)

Asthma 69 69 417,238 417,238 69 417,238 23,699 5.68

Atrial Fibrillation 69 69 417,238 417,238 68 417,163 6,632 1.59

Cancer 69 69 417,238 417,238 69 417,238 6,144 1.47

CHD (Coronary Heart Disease)

69 69 417,238 417,238 69 417,238 19,097 4.58

CKD (Chronic Kidney Disease)

69 69 417,238 417,238 68 417,163 15,364 3.68

COPD (Chronic Obstructive Pulmonary Disease)

69 69 417,238 417,238 68 417,163 9,120 2.19

CVD (Primary Preven-tion of Cardiovascular Disease)

69 69 417,238 417,238 68 417,163 2,167 0.52

Dementia 69 69 417,238 417,238 68 417,163 2,974 0.71

Depression 1 (of 2): conditions assessed for depression

69 69 417,238 417,238 69 417,238 32,875 7.88

Depression 2 (of 2): new diagnosis of depression

69 69 417,238 417,238 69 417,238 20,491 4.91

Diabetes 69 69 417,238 417,238 69 417,238 17,776 4.26

Epilepsy 69 69 417,238 417,238 68 417,163 3,150 0.76

Heart Failure 69 69 417,238 417,238 68 417,163 4,090 0.98

Hypertension 69 69 417,238 417,238 68 417,163 60,091 14.40

Hypothyroidism 69 69 417,238 417,238 69 417,238 20,765 4.98

Learning Disabilities 69 69 417,238 417,238 68 417,163 1,920 0.46

LVD (Left Ventricular Dysfunction)

69 69 417,238 417,238 68 417,163 2,938 0.70

Mental Health 69 69 417,238 417,238 69 417,238 3,866 0.93

Obesity 69 69 417,238 417,238 69 417,238 38,174 9.15

Palliative Care 69 69 417,238 417,238 68 417,163 556 0.13

"Smoking" (conditions assessed for smoking)

69 69 417,238 417,238 69 417,238 103,665 24.85

Stroke & Transient Ischaemic Attack (TIA)

69 69 417,238 417,238 69 417,238 9,849 2.36

Tayside Prevalence Data - Source ISD.scotland

Moredetailonthesewillbecoveredinthefollowing,diseasespecificparagraphs.

25

Alzheimer’s Disease

Rheumatoid Arthritis

Pain Service Summary

Standard Care:TreatmentofallpatientsdiagnosedwithDementiainTaysidearetreatedaccordingtonationallyagreedIntegratedcarepathways(5),SIGNguidelines(researchevidence),andScotland’snationalDementiaStrategyJune2010.(Allavailableonline)

Typical Patient Profile:Over6000patients(>65yrs)withdementiaattimeofwriting,approx2/3(~4000)ofthemcanbeexpectedtosufferfromAlzheimer’s.

Research capability:ResearchRegisterofpatientskeentotakepartinDementiaresearch:Patients124,Carers134.(2/3rdslikelytobeAlzheimer’s)

Population List Size PrevalenceDementia 417,163 2,974 0.71

Standard Care for RA (as per all RA depts):StartonDMARDmedicationswhendiagnosed.Thereismultidisciplinarycareofthesepatients.IfanRApatientfailsontwoDMARDtherapiestheygoontoBiologictreatments.

Approx 3000+ RA patients attending clinicsinNHSTaysidewithabout150-200 new referrals per year.Thenewlydiagnosedpatientsaretreatment naive so say 150-200 per yearthatfitintothatcategory.OfallRApatientsattendingclinics20% (600) would be considered to be mild, 60% (1800) moderate and 20% (600) severe.

Staffing: ThreesitesinTaysidedealingwithRheumatology.4.2fteRheumatologistsinNinewellsalone,with1*Rheumatologyspecialistnurse,1*BiologicsspecialistnurseandanumberofotherexperiencedresearchnurseswithexperienceofrecruitingtoRAtrials,andaccesstoall3000+patientsforthepurposeofclinicaltrials.

NHSTaysideoperatesanIntegratedPainServicemanagingbothacuteandchronicpainfromaMultiDisplinaryperspectiveandprovidesspecialistpainmanagementserviceforalltypesofacuteandchronicpainacrossoursitepopulationof>450000peopleinTayside.Currentlytheserviceseesnewreferralsofaround1700newpatientsperyearWithintheintegratedpainteamthereareLeadConsultantandLeadNurse5xConsultants1xAssocSpecialist6xPainNurses1xAdvancedPhysio3xClinicalPsychologistsTheintegratedteamoperatesfromNinewells,PRIandStracathroHospitalsandalsoprovidescommunity/domiciliaryserviceswhererequired.

26

Schizophrenia

Standards of CareTheintegratedPainservicesincludesstandardofcarewhichembracebothPharmacologicalandnonPharmacologicalpainmanagementstrategies.Pharmacologicallyevidencebased“analgesicladder”formsthebasisofthisapproach.Nonpharmacologicalapproachesinclude,forexample,electrophysiologicalapproachesincludingTENS,ErgonomicapproachessuchasPhysiotherapyandPsychologicalapproachessuchasCBT.ThereisanactiveinterestwithintheSpecialistIntegratedpainTeaminappropriateresearchopportunities

Approx53,000patientstreatedforordiagnosedwithdepressioninTaysideannually.

Standard of careGPReferraltoCommunityMentalHealthTeamforassessment- seenonanemergency/urgent/routinebasisbyCommunity

MentalHealthTeam- Diagnosismadeandtreatmentplansetupunderinformalbasis- Admissionrequiredtoinpatientunit-formal/informal- MultidisciplinarycareprovidedbyCMHTsincludingConsultant

Psychiatrist,Communitynurse,Psychology.Occupationaltherapy,PhysiotherapyandPharmacyinputwhenrequired

- Careinthecommunityalsoincludesdaycare/dayhospitalinput- RoutinecareisonceweeklyappointmentwithCMHN- 6-8weeklyorasrequiredappointmentsbyPsychiatrist, communitynurse New patient profile- Male/female1:1withagerange20-35,usuallycomplicatedwith

drug/alcoholmisuse,socialisolation,unemployed,littlesupportfromfamily/friendsincommunity.

- Approximately~200patientswithdiagnosisofschizophrenia inDundee

Population List size Prevalence

Depression 1 (of 2): conditions assessed for depression

417,238 32,875 7.88

Depression 2 (of 2): new diagnosis of depression

417,238 20,491 4.91

27

NHSTaysidehasahugeheritagebaseincardiovascularmedicineandresearchanditsacuteandchronicdiseaseservicescontinuetoevolve.IndustrypartnershavebeenquicktorecognisethekeystrengthsofourinvestigatorteamsinrecruitingtoandexceedingtargetsandtoourdependantpatientpopulationwhohavebeenwillingtoenrolinarangeofRCT’sinrecentyears.KeyinvestigatorsatsiteincludeProf Jill Belch, Prof Chim Lang, Prof Tom MacDonald and Prof Alan Struthersallofwholeadsuccessfulresearchteams.Successinthistherapyareaisdemonstratedbyoursuccessiveperformanceinrelationto1stGlobal,1stEUand1stUKrandomisedpatientsandourconsistentlymeetingorexceedingagreedrecruitmenttargets.Specificdiseaseprevalence’sandpopulationdataforCVDandrelatedareasarebelow

Population List Size Prevalence

CHD (Coronary Heart Disease) 417,238 19,097 4.58

Heart Failure 417,163 4,090 0.98

Hypertension 417,163 60,091 14.40

Stroke & Transient Ischaemic Attack (TIA)

417,238 9,849 2.36

LVD (Left Ventricular Dysfunction)

417,163 2,938 0.70

StandardofCarePCandSCareintegrated,nationaltargetsforcholesterol,HBA1C,BP.Eyescreencompletedon97%ofpatientsandannualfootscreeningon80%ofpopulation.100%haveCVriskfactorscompletedandtheuseofSCI-DC–ScottishCareInformatics–DiabetesCollaboration.20,000inTayside,Type12000,Type218000NewPatient2000ayear.VeryfewtreatmentnaïvepatientsbecauseofnationaltargetsforGPs.TheQualityandOutcomesFramework(QoF)encouragesGPstokeepmostpatientstotargetandtypeIIpatientswillcommonlybeonmetforminandhaveaHbA1Clessthan7.5%.TaysidePI’sincludeProf Andrew Morris, Prof John Connell, Dr Euan Pearson and Prof Graham Leese.

Population List Size Prevalence

Diabetes 417,238 17,776 4.26

Cardiovascular

Diabetes

28

NHS TaysidehasafullyintegratedRespiratoryservicespanningPrimary,SecondaryandTertiary,(UniversityTeaching),sectors.TheserviceisunifiedwithinanMCN,(ManagedClinicalNetwork),andincludes,GP’swithRespiratorySpecialInterest,CommunityCOPDTeam,RespiratoryLiaisonandSpecialistNurse,Pulmonaryphysiologist,PulmonaryPhysiotherapistsandUniversityAllergyandAsthmaCentre.DiseasemorbiditiesinthecommonChronicRespiratorDiseaseareasareinlinewithnationalprevalenceforUK.

Asthma NHSTayside’sQOFperformanceinPrimaryCareisconsistentlyat100%oftargetdemonstratingtherobustnessoftheproactiveapproachtomanagingasthmacare.Clinicalteamsare“researchaware”andinterestedinparticipatinginresearchwhichdeliversonimprovingpatientcareandexperience.Inaddition,atUniversityLevelwehaveanestablishedAsthmaandAllergyresearchCentreunderProfBJLipworthwhowecanapproachtoreviewandinnovativeandinterestingfeasibilities.Specificasthmamorbidityandprevalencenumbersareasfollows

Population Asthma List Prevalence

Asthma 417,238 23,699 5.68

COPDAsforasthma,NHSTaysidehasconsiderableexpertiseincrossfunctionalmanagementofCOPDwithwellprovenandsustainablelinksbetweenPrimaryandSecondaryCareserviceprovision.MoreimportantlythereexistsasubstantialdatabaseofRespiratorypatients(currentlyinexcessof11000patients)recordsofassessmentsanddiseasemeasurementsspanning5yearstodate.OurChestteamareveryresearchactivewithconsiderableinterestininnovativeclinicaltrials

SpecificCOPDmorbidityandprevalencedataareasfollows

Population COPD List Prevalence

COPD (Chronic Obstructive Pulmonary Disease)

417,163 9,120 2.19

ThemanagementofcancerisaNationalPrioritywithinNHSScotlandandconsequentlytheprovisionofservicesforcancerdiagnosis,management,treatmentsandpalliationareaffordedahighpriority.InlinewiththisthereisahugeheritageofuptakeandsuccessinavastrangeofclinicaltrialsspanninginCancerbeitsolidornonsolidtumour.TherearededicatedCancerresearchteamswithwellrespectedresearchersacrossallthemainTumourGroupsincludingLung,Breast,Colorectal,UpperGI,HeadandNeck,dermatological,Neuro-Oncologyandhaematooncology.

Population GP Cancer Numbers

Prevalence

Cancer 417,238 6,144 1.47

Respiratory

Cancer

29

TheTaysideChildren’sHospitalResearchFacilitywasopenedin2007.Theenvironmentisjointlyutilisedforbothpaediatricresearchparticipationandclinicalinvestigations.Itisasafe,ageappropriateenvironmentforallchildren,youngpeopleandtheirfamilies.Informationleafletsdetailingtheavailablefacilitiesandservicescanbeprovided.

Childrenandyoungpeopleofallagesandhealthconditionattendtheareaforparticipationinresearchstudies.TheyareattendedbyexperiencedpaediatricresearchnurseswhoarefundedbyoraffiliatedtotheScottishChildren’sResearchNetwork.Theresearchnursesareexperiencedpaediatricnurseswithexpertiseincommunicatingwithchildrenofallageswhichisanessentialskillforobtainingconsentandassent;acoreaspectofresearchparticipation.

AllresearchstudiescarriedoutintheCRFadheretoICH-GCPstandards,EUDirectives,theResearchGovernanceFrameworkforHealthandSocialCare(2005)standards.

StudyadoptionbytheScottishChildren’sResearchNetworkprovidesassistancewithregulatoryapproval,studyset-up,training&educationofstaff,supervisionofstaffandaccesstoageappropriateinformationsheets,consentandassentformsandpaediatricspecificstandardoperatingprocedures.

TheresearchactivitywithintheCRFhassteadilyincreasedoverrecentyearsfrombothcommercialandclinicalresearchorganisations.ThefacilityhasenhancedlinkswithNHSTayside,UniversityofDundee,TASC,HIC,Geneticsandpaediatricspecialitydepartments.ProjectsarealsobeingcarriedoutincollaborationwithspecialistnetworkssuchasDiabetes,MentalHealthandPrimaryCareandtheEpilepsymanagedclinicalnetworkbothlocallyandnationally.

Researchiscurrentlybeingcarriedoutinthefollowingspecialities:• ChildBehaviour-Dr Coghill• Dermatology- Dr Hearn• Diabetes-Professor Greene• Epilepsy-Dr Kirkpatrick• Genetics-Dr Berg• Neurodisability-Dr Naismith• PrimaryCare-Professor Sullivan• Respiratory- Dr McCormick

Notransplantserviceatsite

Additionalinvestigatorinformation,population,diseaseprevalenceandmanagementdatacanbeissuedonrequest

Adetailedlistofactiveinvestigatorbytherapycanbeprovidedonrequest

Fullyacceptedwhenthereisnoavailableeffectivetreatmentcomparator.

Children Research

Transplant Rejection

Additional Site Information

Tayside Principal Investigators

Placebo Controlled Trials

30