improving proactive quality management in outsourced clinical … · 2020-06-17 · aqc timeline,...
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AvocaQualityConsortium
ImprovingProactiveQualityManagementinOutsourcedClinicalTrials
TheAvocaQualityConsortiumbringstogetherquality,outsourcingandoperationalprofessionalsfrommemberpharma,biotech,nicheclinicalserviceproviders,andCROorganizationstoaccelerateandstreamlineclinicaltrialexecutionandimprovequalitythroughindustrycollaboration.
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2016AQCMembers: PharmaandBiotech
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2016AQCMembers: CROsandAssociateMembers
Longboat
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MemberTestimonials
“WhatsetsAvocaapartisAvocagetsthingsdone.Theyareefficientintheexecutionand
implementationofideasthatweallbringanddeveloptoolsthatwecanalluseandareofvalue.”
JeffreyP.McMullenChairman,inVentivHealthClinicalandViceChairman,inVentivHealth,Inc.
“Thisisaplaceofactiontochangebehaviorstomovetheindustryfor
bothsponsorsandproviders,becauseweneedbothsidesofthatcoin.”
ColleenGlessnerVicePresident,R&DQualityandCompliance,Alexion Pharmaceuticals
“WhatI’mreallypleasedaboutwiththeAvocaQualityConsortiumisthatthey’veactuallybrought
forwardtangibleimprovementsandallowedustoimplementtheseandimprovequalityintheindustry.”
StephenCutler,PhDChiefOperatingOffice,ICONplc
“ThisConsortiumenablesmetolistentothelessonslearnedandbestpracticesfromother
companies,bothsmallandlarge.Thevaluehereistospeakanddefineit,andcometoagreement
onsomekeyareasaroundquality.”
MitchellKatz,PhDExecutiveDirector,MedicalResearchOperations,PurduePharmaLP
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AvocaQualityConsortiumTheAvoca QualityConsortium bringstogether quality,outsourcing,andoperational professionals fromMemberpharma,biotech,nicheclinical serviceproviders,andCROorganizationstoaccelerate the development ofleading practicesandindustrystandardsforproactivequality management andriskmitigation inclinicalresearch.
● AvocaResearch:GatheringofquantitativeandqualitativedatafromMembers;provisionofaggregatedataandindividualbenchmarkingreports.
● LeadingPractices:Developmentofguidelines,tools,approaches,standards,andtemplatesfocusedonproactivequalitymanagement.
Collaboration |ProactiveApproaches
AvocaResearch
IndustryLeadingPractices
AvocaQuality
Consortium
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AQCTimeline,History,andDeliverables
• QualityOversightGuidelines&Tools
• StandardsforPrequalificationofTechnicalServiceProviders
• ProactiveRiskIdentificationToolsandQbDPrinciples
• Study-levelQualityMetrics
• ResearchofMembers’QualityManagementPractices
• Researchwithinvestigativesitesfocusedonqualityandclinicaltrialexecution(incollaborationwithSCRS)
• CollaborationthroughcreationofAQCOnlineCommunity,Aha!
• StandardsforPrequalificationofTechnicalServiceProviders- Inclusionofadditionalservices
• QualityManagementFramework
• ProtocolQualityPrinciples
• Study-levelQualityMetrics
• BenchmarkingresearchonQualityManagementSystems
• QualityAgreementtemplate
• LaunchofQualityMetricswork- Identificationofgaps,insight
• ReportofConsortiumMemberqualitypracticesandapproaches
2012
• QualityMetricsTaxonomyandFramework
• Eight-elementframeworkforProactiveQualityManagementandEffectiveOversight
• AQCResearchonRiskManagement
• Industryapproachestoprequalificationandroutinesystemsauditsoffull-serviceCROsandnicheproviders
2013 2014
20152011
• MeetingwithFDAtodiscuss2011industryresearchonqualityofoutsourcedtrials
• FormationofAvocaQualityConsortium,sponsoredbyEliLillyandPfizer
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AQCProactiveQualityManagementFramework
QualityAgreement
TemplatesandConcepts
Leading-practiceQualityOversightGuidelinesand
Tools
RiskAssessmentandManagement
QualitybyDesign(QbD)
Principles
MetricsTaxonomyand
Outcomes-basedQualityMetrics
CoreandTechnicalIndustryStandardsfor
ProviderPrequalification
AQCResearch
AQCCollaborationOpportunities
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QualityOversightFramework– Continuationin2016
*DocumentscontinuouslyupdatedtostaycurrentwithindustrychangesandtoincorporateMemberfeedback.
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QualityOversightFramework,GuidelinesandTools- Background
AccomplishmentstoDate
• DevelopmentofEightComponentconstructforEffectiveQualityOversightforOutsourcedProgramswithover190leadingpracticeguidelinesandtoolswithaparticularfocuson:– QualityOversightGuidelines andtools
– QualityAgreement template– QualityMetricsandTaxonomy;provisionofQualityMetricsmappedtoTaxonomy
– QbDPrinciples andtools– RiskManagementFrameworkandtools
• IndepthdiscussionandexplorationofleadingpracticesviaCaseStudiesandWebinars• CollaborationregardingoversightpracticesonAha,theAQConlinecommunity• ReviewbyanddiscussionswithEMAinpreparationfor2014DIAsessionfocusedoneffective
oversight• Recent(October2015)reviewbyanddiscussionswithFDA• AcknowledgementbyMembercompanyrepresentativesthroughconsistentpositivefeedback
regardingtherichnessofthecontentandqualityoftheguidelinesandtools
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QualityOversightFramework,GuidelinesandTools- Background
DuringtheOctober21,2015AQCMembers’WorkingSessioninPrinceton,NJ,RaviPatel,RPh,PharmD,MBA,Sr.Director,HeadofGlobalPharmacovigilance&DrugSafetyOperations,AlexionPharmaceuticals,Inc.quotedacommentfromanFDAinspectorthatfollowedaninspectionoftheirpharmacovigilanceprogramwhereAQCtoolshadbeenusedtooverseeoutsourcedprograms…
FDAInspectorQuote:“ThiswasthemostcomprehensiveOversightplanwehaveseensofarforpatientsupportprograms.”
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QualityMetricsInitiative:MakingSenseofConsortiumMetrics
!!!
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!!!
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!!!
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!Adequate!protec-on!of!subjects’!rights!!!!!Adequate!protec-on!of!subjects’!safety/welfare!!
Scien-fically!valid!and!ethically!!sound!(parsimonious)!experimental!design!!
Integrity!of!data! ! ! !!!
Execu-on!of!study!per!protocol!
FOUNDATIONS!!FOR!!ENSU
REING!QUALITY!
Outcom
es!(u
l-mate!“rep
ort!card”)!
Frac4on
!of!studies!achieving!passable!levels!
Process!q
uality!
(Doe
s!process,!whe
n!followed
,!lead!to!desired
!outcome?)!
Process!A
dheren
ce!!
(Is!process!be
ing!followed
?)!
Enterprise!Management!
Integrity!of!data!analysis!and!interpreta-on! ! ! !!
Adequacy!of!documenta-on!of!all!aspects!of!study!
Contributors!Predictors!Outcomes!
Quality!Metrics:!Three!Categories!
Basis!for!Quality!Metrics!
!•!!!Protocol!will!answer!intended!scien4fic!ques4on!!•!!!Protocol!compliance!is!achievable!
!!•!!!Pa4ents!not!exposed!to!any!more!risk!than!necessary!!•!!!Minimize!unnecessary!procedures!
•!!!Qualified!Inves4gators!•!!!100%!of!subjects!“evaluable”!for!analysis!
!•!!!Compliance!with!protocol!procedures!!•!!!Integrity!of!randomiza4on!and!of!the!blind!!•!!!Integrity!of!inves4ga4onal!product!!•!!!Sufficient!subject!reten4on!
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!!!
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CATEGORY! OPTIMAL!OUTCOME!No!GCP/regulatory!viola4ons!• All!subjects!consented!appropriately!
throughout!study!• Ethics!approvals!• Appropriate!medical!care!
!!!!!!!!!No!GCP/regulatory!viola4ons!!•!!!Qualified!safety!reviews!and!inves4gator/pa4ent!
! !!!!!!!no4fica4on!performed!promptly!!•!!!Integrity!of!inves4ga4onal!product!
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Database!provides!100%!accurate!reflec4on!of!study!experience!
!!!!
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Data!analysis!is!sta4s4cally!valid,!free!of!errors,!and!interpreted!by!qualified!personnel.!
!
TheAQCselectedQualityMetricsasaninitial initiative becauseresearchshowedthatsponsorsandCROswerereportinglowlevels ofsatisfactionwiththeirownapproachestomeasuringquality.TheworktheAQCconductedstartedwithananalysisofhowtheindustryapproachesqualitymetrics.Ultimately, theAQCdevelopedataxonomyandframeworkforQualityMetricswithanemphasisonqualityoutcomes.
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ApproachtoQualityMetricsFramework
QualityOutcomes– 7MajorCategories
Protectionofsubjects’rights
Protectionofsubjects’safety/welfare
DOCUMENTATION
Executionofstudyperprotocol
Integrityofdata(accuratereflectionofresults)
Appropriateandaccurateanalysisandreporting (leadstoscientificallyappropriateconclusions)
Scientificallyvalid/achievable/clearprotocol
Technical Attributes
EthicalAttributes
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AQCPrequalificationInitiative
TheAQCPrequalificationinitiativeisdesignedtotransformthewaytheindustryprequalifiestheirtechnicalproviderstoimprovequalityandefficiencyinclinicaltrials.
• Introduceamorecost,timeandresourceefficientmodel
• Deliveramoretransparent,consistentmessagetoProvidersforstandardsofqualityinordertoshortentimeframesofonboardingnichesuppliers
• Dispelcommonnotionsthatliabilityandlegalriskshroudasmarter,moreefficientapproach
• Provideindustryleadershiprecognizingthatprequalificationisnotasourceofcompetitiveadvantageand
• Reduceriskintheconductofclinicaltrials
TheIndustryChallenge:Prequalificationisanareaofdysfunctionintheindustry.ProvidersandSponsorssuffernegativecostandresourceimplicationsduetoduplicativeefforts,andrealizeanopportunitycostintheabsenceofabettermodel.
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VisionforPrequalificationInitiative
ü Reducedcostsforsponsors,CROsandnicheproviders
ü Shortenedtimeframesforonboardingnichesuppliers
ü Greaterefficiencythroughsharingofinformation
ü Reducedriskintheconductofclinicaltrials
AQCPortalScreenshot*
In2016,theAQCPrequalification InitiativewillincludeAQCMemberaccesstocentralizedRFIinformation.
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ConsortiumMemberscanaccess allcompleted guidelines, templates,andtoolsthroughAvoca’suser-friendly technologyplatformwhichpermitsMemberstoextractthecomponents andsections ofdocuments thattheyneedfortheirrespective organizations.
IndustryLeadingPractices
QualityConsortium2016:Benefits
• Partnered,CollaborativeApproachestoInspectionReadiness
• LeadingPracticeApproachestoProtocolDesignandProtocolQuality
• ComprehensiveEffectiveQualityOversightGuidelinesandTools
– Refinement,revisionandretiringofLeadingPracticeDocumentsontheAQCOversightwebportal
• QualityMetricsFramework,TaxonomyandStudyLevelMetrics–ImplementationCaseStudies
• QualityAgreementtemplate:revisionandrefinement
• PrequalificationInitiativefocusedontechnicalserviceproviders
• AccesstoAvocaQualityConsortiumCommunityPortal
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QualityConsortium2016: Benefits
ConsortiumResearch
• 2016Researchonquality-promotingpractices
• 2015ResearchfocusonQualityManagementSystemsandProtocolQuality
• 2014ResearchofConsortiumMembers’qualitymanagementpractices
• 2014Researchwithinvestigativesitesfocusedonqualityandclinicaltrialexecution(incollaborationwiththeSocietyforClinicalResearchSites)
• 2013AQCresearchonRiskManagement
• 2013Industryapproachestoprequalificationandroutinesystemsauditsoffull-serviceCROsandnicheproviders
• 2012ReportofConsortiumMemberqualitypracticesandapproaches
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MemberMeetings
andForums
QualityConsortium2016:Benefits
• Participation inAQCeducationalwebinarseries,designedtoaddressareasofdysfunctioninproactivequalitymanagement.Topicsinclude:– Culture,People,Process,Technology:Operationalizing Integrated
ApproachestoClinicalTrialExecution
– DesignThinkingMethodologytopromoteintegrationacrosscomponentsofaqualitymanagementframeworkandcollaborationacrosssourcingpartners
– Traitsthatembodythe“Clinical OperationsProfessionaloftheFuture”
• Aha!OnlineCommunity:MemberscanaskquestionsofeachotherandofAvocathroughanonlineplatformusedtoorientMemberstoexistingleading-practicedocuments,researchand,tointroducenewideasandapproaches.
• Participation atthefollowing2016meetings:– USSummit:May10-11,inPrinceton,NJ
– InauguralAQCEuropeanSummit:June6-7,inBasel,Switzerland– FallMembersWorkingSession
– Opportunitiesforexecutiveengagementviaregionalnetworkingmeetings
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Foradditionalinformation,pleasecontact:[email protected]
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