using risk-based approaches to quality management...for fully-outsourced clinical trials, to what...

The2017AvocaIndustryReport

UsingRisk-BasedApproachestoQualityManagement

September2017

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2017AvocaIndustryReportSeries

Eachyear,TheAvocaGroupsurveysindustryprofessionalstounderstandtrendsinclinicaldevelopment,withaparticularfocusonoutsourcingdynamicsandrelationshipsbetweenresearchSponsorsandProviders.

In2017,AvocaissuedtheIndustryReport,whichisahighleveloverviewofkeyresults.

Inaddition,Avocaisissuingaseriesoffollow-upreportsthatexaminespecificareasingreaterdetail,withthisbeingthesecondinthisseries.

IndustryReport

UsingTechnology

inaRisk-Based

Risk-BasedMonitoring

Risk-BasedQuality

Risk-BasedInspection

Risk-BasedOversight

Management

Environment

Preparedness

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NoreproductionoftheinformationinthisreportmaybemadewithouttheexpresspriorwrittenconsentofTheAvocaGroup.Allinquiriesandrequestsforconsentforreproductionanduse,includingintegratingelementsofthisreportintotherecipients’ownworkproducts(e.g.,presentations),shouldbedirectedtoDennisSalottiviaemailatDennis.Salotti@theavocagroup.com.

UsageGuidelines

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Methodology

• AllfieldworkwasconductedbetweenMarchandJuneof2017.

• Atotalof273completedsurveyswerereceivedfromrespondentsrepresenting94individualSponsororganizations.

• Atotalof121completedsurveyswerecollectedfromrespondentsrepresenting49individualProviderorganizations.

• Classificationinformationaboutrespondentsandcompaniestheyrepresentcanbefoundintheappendixofthisreport.

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SummaryofKeyToplineFindings:IndustrySurveyonRisk

• Despitemarkedshiftsinthelandscapeandinregulatoryrequirements,thesedatasuggestthatlittlehaschangedwithrespecttohowtheIndustryisapproachingandmanagingriskassessment.

• Thealignmentofpeopleandprocessesappearstobeasignificantbarrier inmorewidespreadadoptionofrisk-basedtechniquestoclinicaltrialmanagement.

• LargegapscontinuetoexistbetweenhowSponsorsperceivetheirenvironment,andspecificallytheirrelationshipswithProviders,andhowProvidersperceivetheirownperformance.

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KeyFindingsRisk-BasedQualityManagement

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Thoughnearly70%ofSponsorrespondentsindicatehavinga“good”or“verygood”understandingofbestpracticesinrisk-basedqualitymanagement,thiswaslowerthanthenearly90%ofProviderswhoindicatedthislevelofknowledge.

Risk-BasedQualityManagement

FamiliaritywithRisk-BasedApproachestoQualityManagement%havinga“good”or“verystrong”understandingofbestpractices

N:SPONSOR:Total=271;PROVIDER:Total=118Q:Howwouldyourateyourunderstandingofbestpracticesin…?

Sponsors Providers

69% 89%

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AmongProviders,understandingofrisk-basedqualitymanagementwasconsistentbyfunction;however,amongSponsors,thoseinClinicalOperationsexpressedasubstantiallylowerleveloffamiliaritythandidthoserepresentingthequalityfunction.


90%

64%

96% 91%

Quality ClinicalOperations Quality ClinicalOperations

N:SPONSOR:Quality=59,ClinicalOperations=154;PROVIDER:Quality=26,ClinicalOperations=46Q:Howwouldyourateyourunderstandingofbestpracticesin…?

Quality ClinicalOperations

Quality ClinicalOperations

FamiliaritywithRisk-BasedApproachestoQualityManagementbyFunction%havinga“good”or“verystrong”understandingofbestpractices

Sponsor Provider

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Approximately50%- 60%ofrespondentsreportedthatrisk-basedqualitymanagementisbeingutilizedinatleasthalfofthetrialstheyrun.


Sponsor Provider

FrequencyofUseofRisk-BasedQualityManagement%oftrialsutilizingrisk-basedqualitymanagementapproach

N:SPONSOR=226;PROVIDER=83SPONSORQ:Howoftendoyourteamsusearisk-basedapproachto…?PROVIDERQ:Howoftendoesyourcompanyusearisk-basedapproachto…?

Morethan75%

51%to75%

25%to50%

1%to24%

Never

32%

20%23%

17%

8%

39%

18%

23%

18%2%

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Whetherin-houseoroutsourced,respondentsfromTop20Sponsororganizationsreportgreaterutilizationofrisk-basedqualitymanagementthandothoserepresentingsmallerorganizations.


59%

41%

64%

49%

Top20 AllOther Top20 AllOther

N:SPONSOR:In-house:Top20=71,Allother=112;Outsourced:Top20=81,AllOther=129SPONSORQ:Howoftendoyourteamsusearisk-basedapproachto…?SPONSORQ:Howoftendoyouusearisk-basedapproachtoprepareforinspectionsforclinicaltrialswithfunctionsoutsourcedtoFSPs

Top20 AllOther Top20 AllOther

In-houseTrials OutsourcedTrials

FrequencyofUseofRisk-BasedQualityManagementbySponsorSize%indicatingthatrisk-basedqualitymanagementapproachisusedinatleasthalfoftrials

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Regardlessoftheoutsourcingmodel,Sponsorsprimarilyindicatinginitiatingtheuseofrisk-basedqualitymanagement.Designofthisapproachisamoresharedresponsibilityinfull-servicevs.FSPrelationships.Providersarelikelytoseethemselvesasdrivingbothinitiationanddesignofqualitymanagement.


N:SPONSORFull-service=82-84;SPONSORFSP=105-114;PROVIDER=89-91SPONSORQ:Forfully-outsourcedclinicaltrials,whogenerallyinitiates/requeststheuseof…?Q:Forclinicaltrialsutilizing functionalserviceproviders,whogenerallyinitiates/requeststheuseof…?Forfully-outsourcedclinicaltrials,towhatextentistheCRO generallyinvolvedindesigningtheapproachto…?Forclinicaltrialsutilizingfunctionalserviceproviders,towhatextentistheFSP generallyinvolvedindesigningtheapproachto…?PROVIDERQ:Whogenerallyinitiates/requeststheuseof…?Towhatextentisyourcompanygenerallyinvolvedindesigningtheapproachto…?

Sponsors Providers

Initiates UseofRisk-BasedQualityManagement

62%75%

24% 18%14% 7%

FullService FSP

Sponsor Mix Provider

34%

68%55%

28%11% 5%

9%

38%53%

9%

34%

57%

InvolvedinDesignofApproachtoRisk-BasedQualityManagement

Full-service FSP

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SponsorAssessmentofCROs/FSPs ProviderSelf-Assessment

AlargedisparityexistsintermsofSponsors’perceptionsofProviderperformanceonapplyingrisk-basedapproachestoqualitymanagement,andProviders’self-assessmentsinthisarea.


N:SPONSOR=189;PROVIDER=85SPONSORQ:Overall,howsatisfiedhaveyoubeenwiththeCROs/FSPsyouworkwithintermsoftheir…?PROVIDERQ:Overall,howsatisfiedhaveyoubeenwithyourcompanyintermsofthe…?

SatisfactionwithRisk-BasedApproachtoQualityManagement%selectingresponse

Verysatisfied

Somewhatsatisfied

NeithersatisfiednordissatisfiedSomewhatdissatisfied

Verydissatisfied

10%

30%

32%

23%

6%

33%

41%

18%

7%1%

%satisfied40%

%satisfied74%

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Sponsor Provider

Approximatelyhalfofrespondentsindicatethatrisk-basedqualitymanagementhasbeen“very”or“extremely”impactfulonincreasingqualityintrials;fewerfeelthisisresultinginimprovementstoefficiencyintermsoftimeorresources.Thoseinafull-servicemodelexpressseeinggreaterimpact.


N:SPONSOR:Total=144-155,Full-service=60-65,FSP=84-90;PROVIDER=94-96Q:Howimpactfulhavethefollowingrisk-basedapproachesbeenintermsofincreasing…?

ImpactofRisk-BasedApproachtoQualityManagementonIncreasing…%“extremely”or“veryimpactful”

46%

19% 16%

48%

24% 22%

Quality Timeliness ResourceEfficiency

51% 28% 23%

42% 13% 11%

Full-service

FSP

Sponsorsusing:

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Verbatimcommentaryontheuseofrisk-basedqualitymanagementsuggeststhatitcanpositivelyinfluenceawareness,communicationandstrategy,butthatchallengesremainingainingalignmentonrationale,processandmeasurement.

Q:Consideringyourcompany’suseofrisk-basedapproachestoclinicaltrialconduct,whataspectofthesehasbeenthemostchallenging?

PositiveImpacts ChallengesRisk-BasedQualityManagement

“Sometimesinterpretingthedataformeaningfulconclusionsisdifficult.Also,thelackofunderstandingbymostonhowtousethedata.”

“UnderstandingwhatQRMis,understandingwhywearedoingit,understandingthresholdsaroundKRIs.”

“Mindshift- understandingthatimplementingQRMandRBMisnotaboutsavingmoney.Teamsstillreportissues,notrisks,andrisksidentifiedaremainlyfocusingontimelineandbudget,notonquality.”

“Planninghasopenedcommunicationamongstteam..”

“Increasedawarenessofthreatstoqualityofstudy.”

“Ourteamsareconstantlymeetingandreassessingtomakesurethatthepotentialrisksandactualrisksarebeingpointedoutanddealtwith.”

“Earlyproactiverisk-basedstrategizing.ExamineallpossibilitiesandpotentialtodecreaserisksBeforemakingdecisions.Usually,risksaredecreased,moneyissaved,andefficiencyisincreased.”

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KeyTake-AwaysforRisk-BasedQualityManagement

• Overall,SponsorsandProvidersreportafairlygoodunderstandingofbestpracticesinrisk-basedqualitymanagement;however,amongSponsorsthisknowledgeprimarily“lives”amongthoseintheQualityfunction.

• Sponsorsreportprimarilyinitiatingqualitymanagementapproachesinoutsourcedtrials,butthedesignofthisapproachismoreofasharedresponsibilitywithinfull-servicesourcing.Providersgenerallyseethisasajointeffort.

• ThereisanotablediscrepancybetweenSponsorsandProvidersintermsofProviderperformanceonapplyingrisk-basedqualitymanagementapproaches.

• Risk-basedqualitymanagementisseenashavingthegreatestimpactonquality,andmuchlessimpactonefficiency.Thoseusingfull-servicesourcingapproachesappeartoberealizingsomewhatgreaterbenefitsthanthoseusingfunctionalsourcingmodels.

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Thankyou

ContactAvocaat:(609)252-9020

[email protected]

179NassauStreet,Suite3APrinceton,NJ08542

AvocaIntegratedConsultingandResearchdeliversafreshperspective— aclear,andneutraltakeonhowtoincreaseefficiency,improvequality,andmitigateriskinclinicaltrialexecutionandmanagement.

Avocapairsbest-in-classresearchcapabilitieswithateamthatunderstandswhattrendsmeanfortheindustryandhowtheyaffectyourday-to-daybusiness.

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Pharmaceutical/Biotech ServiceProvidersAvocaClientList

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AppendixDemographics

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Top20Biopharma

Top50/Mid-sizedBiopharma

OtherMid-sizedBiopharma

Small/SpecialtyBiopharma

Other

Top20Biopharma($10+billionsales)Top50/Mid-sizedBiopharma($2.0- $9.9billionsales)OtherMid-sizedBiopharma($500million- $1.9billionsales)Small/SpecialtyBiopharma(<$500millionsales)MedicalDevicecompany

Other

39%

12%16%

27%

5%1%

SPONSOR:CompanySize

UnitedStates

WesternEurope

Other

SPONSOR:CompanyHeadquarters

81%

12%6%

N=273

N=242

CompanyCharacteristics

PROVIDER:CompanyType

UnitedStates

WesternEurope

Other

PROVIDER:CompanyHeadquarters

CRO

ClinicalServiceProvider

ConsultingCompany

Other

76%

19%5%

N=101

73%

13%

8%6%

N=121

21

10yearsorless

Morethan10years

13%

87%

SPONSOR:TimeinIndustry

SPONSOR:PrimaryFunctionalArea

N=242

RespondentCharacteristics

PROVIDER:TimeinIndustry

PROVIDER:PrimaryFunctionalArea

10yearsorless

Morethan10years

9%

91%

N=101

39%21%

12%8%6%4%1%

8%

ClinicalDev't/OperationsQualityAssurance/Control

ExecutiveManagementAllianceMgmt/Partnerships

BusinessDevelopmentMedical/ScientificRegulatoryAffairs

Other

N=121N=273

57%22%

7%3%3%3%1%4%

ClinicalDev't/OperationsQualityAssurance/Control

Procurement/VendorMgmtRegulatoryAffairs

MedicalAffairs/ScientificExecutiveManagement

AllianceMgmt/PartnershipsOther

using risk-based approaches to quality management...for fully-outsourced clinical trials, to what...

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