7/31/2019 Gssu Survey 2012

1/18

2012DrugDevInc.

2012GlobalSiteID&Start-UpSurvey

Contents

COPYRIGHT........................................................................................................................................2

INTRODUCTION..................................................................................................................................3

KEYSTUDYFINDINGS.........................................................................................................................3

DETAILEDSTUDYFINDINGS...............................................................................................................4

SURVEYRESPONDENTS......................................................................................................................4

CURRENTSTATUSOFCLINICALTRIALPROGRAMS............................................................................6

SITEIDENTIFICATION.........................................................................................................................8

STUDYSTART-UP..............................................................................................................................13

THEROLEOFMONITORING.............................................................................................................15

EARLYENGAGEMENT.......................................................................................................................16

7/31/2019 Gssu Survey 2012

2/18

2012DrugDevInc.

COPYRIGHT

Thankyouforyourinterestinthis2012GlobalSiteID&Start-UpSurvey.Pleasereadandobservethe

followingarticlesassociatedwiththeuseanddistributionofthecontentsofthisreport.

Everyoneispermittedtocopyanddistributenon-commercialandverbatimcopiesofthisreport,but

changingitorchargingmoneyforitisnotallowed.DrugDevIncdoesnotwarrant,eitherexpresslyorimplied,theaccuracy,timeliness,orappropriatenessoftheinformationcontainedinthisreport.

DrugDevIncdisclaimsanyresponsibilityforcontenterrors,omissions,orinfringingmaterialand

disclaimsanyresponsibilityassociatedwithrelyingontheinformationprovidedinthereport.

Everyoneisfreetoincludeelementsofthisreportinhisorherownworkproducts(i.e.,reportsand

presentations),providingthattheelementscarrywiththemacitationstating:Source:GlobalSiteID&

Start-UpSurvey,DrugDevInc,2012."

Noadvertisingorotherpromotionalusecanbemadeoftheinformationinthisreportwithoutthe

expresspriorwrittenconsentofDrugDevInc.Forsuchconsent,pleasecontact busdev@drugdev.org

7/31/2019 Gssu Survey 2012

3/18

2012DrugDevInc.

INTRODUCTION

Wearepleasedtopresenttheresultsofthe2012GlobalSiteID&Start-UpSurvey,andtakethis

opportunitytothankeveryonewhoparticipatedinthissurvey.Wetrustyouwillenjoyreadingthe

resultsofthisresearch,whichpresentaunique,uptodatesnapshotofthechallengesfacingdrugdevelopmenttoday.

Clinicaltrialstudymanagersandprojectmanagersfromacrosstheglobeparticipatedinthisresearch,

withrepresentationfromNorthAmerica,Europe,includingEasternEurope,andAsia-Pacific.Morethan

220responseswerereceived,with23%frombigpharma,14%fromsmall-mediumpharmaand63%

fromlargeCROs.Feasibilityspecialistsaccountedfor8%ofresponders,andtheirresultsarereported

separately.Responderswereactivelyinvolvedintrialsacrossawiderangeoftherapeuticareas,

includingthekeyareasofOncology,InfectiousDiseases,Cardiovascular,Neurology,Psychiatry,

Endocrinology/DiabetesandGastrointestinal.

KEYSTUDYFINDINGS

Siteidentificationandstudystart-upareacknowledgedtobecriticalrate-limitingstepstothesuccessof

clinicalstudies.Inthissurvey,siteidentificationwasreportedtotakeanaverageof6weeks,withtwo-

thirdsofrespondentsreportingthatanaveragetrialtakesfurther3monthsbeforethefirstpatient

enrolment.Morethantwo-thirdsofrespondentsindicatedacurrentandurgentneedforadditional

sitesontheiractivetrials.

Despitethesefindings,asurprisinglyhighproportionofrespondersindicatedthattheyweresatisfied

withtheircurrentmethodsofsiteselectionandsitestart-up,althoughthoseworkinginPharmawere

lesssatisfiedthattheirCROcolleagues.Outsourcingofclinicaltrialswasnotassociatedwith

improvementsintheproportionoffullysite-resourcedtrials,thetimetakenforsiteidentification,the

timetakenforstudystart-up,ortheproportionofsitesreachingrecruitmenttargets.

Earlyengagementofinvestigatorswasconsideredtobeakeystepinovercomingthenotoriouslyslow

processesleadinguptositeinitiation.Morethan84%ofsurveyrespondentssawthevalueofearly

engagement,butonly57%hadactivelyengagedinthisprocess.

Contingentstart-upmethods,whereathirdpartyprovidesapatientenrolmentguaranteeforthesitesthatitidentifiesandtakestostart-up,hadbeenpreviouslyusedbyonly10%ofrespondents.This

method,alongwithformalearlyengagementprocesses,arelikelytogosomewaytoaddressingthe

slownessofsiteidentification,start-upandreducingtheproportionofsitesfailingtorecruit.

7/31/2019 Gssu Survey 2012

4/18

2012DrugDevInc.

DETAILEDSTUDYFINDINGS

SURVEYRESPONDENTS

Atotalof221surveyresponseswerereceived.Overall,21differentcountrieswererepresentedinthe

surveygroup,reachingacrosstheglobe.

JustoverhalfofthesurveyrespondentsreportedworkingforalargeCRO,withtheremainderworking

foraPharmaorBiotechcompany.

Asia-Pacific

7%

Europe

18%

North

America

58%

Other

3%

United

Kingdom

15%

LocaAon

LargePharma/Biotech

23%

SmallPharma/Biotech

14%

LargeContractResearch

Organizaon

63%

OrganizaAon

7/31/2019 Gssu Survey 2012

5/18

2012DrugDevInc.

Whattherapeuticareasareyoucurrentlyworkingin?

Allmajortherapeuticareasinclinicaltrialswererepresentedinthesurvey,withatop5ofOncology,

Cardiovascular,InfectiousDiseases,NeurologyandPsychiatry.Interestingly,agreaterpercentageof

Oncologytrialswereconductedin-housebyPharma,whileahigherpercentageofCardiovasculartrials

wereoutsourcedtoCROs.

Top10 Overall Pharma CRO

1 Oncology 30% Oncology Oncology

2 Cardiovascular 23% Neurology Cardiovascular

3 InfectiousDiseases 20% Cardiovascular InfectiousDiseases

4 Neurology 19% InfectiousDiseases Psychiatry

5 Psychiatry 19% Psychiatry Endocrinology/Diabetes

6 Endocrinology/Diabetes 16% Endocrinology/Diabetes Neurology

7 Pulmonary/Respiratory 10% Pain/Sleep Pulmonary/Respiratory

8 Pain/Sleep 9% Immunology/Allergy Pediatrics

9 Pediatrics 9% Pulmonary/Respiratory Hematology

10 Hematology 7% Gastrointestinal Rheumatology

7/31/2019 Gssu Survey 2012

6/18

2012DrugDevInc.

CURRENTSTATUSOFCLINICALTRIALPROGRAMSHowmanyclinicaltrialsareyouworkingonrightnow?

Overall,aroundhalfoftherespondentstothesurveywereworkingon1-2activeprojects,withtheaveragenumberoftrialsat3 .ThosewhoworkedinPharmareportedahighernumberofcurrently

activetrialsthanthoseworkingforaCRO,whichmayreflectdifferentmanagementstructurestyles.

HowmanyofthesetrialsstillneedMOREsitestobeidentified/started-up?

lmosttwo-thirdsofrespondentsreportaneedformoresitestobeidentifiedorstartedupfortheir

currentlyactivetrials.ThoseworkingforaCROweremorelikelytoreportaneedforadditionalsites,

with69%indicatingthatcurrentlyactivetrialsarenotfullysite-resourced.Basedontheaverage

numbersofactivetrialsperrespondent,thesedataindicatethataround40%ofthePharma-runtrials,

andmorethan60%ofCRO-runtrialsrequireimmediatesiteidentificationandstart-uptoensure

currentlyactivetrialsmeettargets.

0% 10% 20% 30% 40% 50% 60%

1-2

3-4

5-6

7-8

Morethan8

Howmanytrials?

CRO

Pharma

7/31/2019 Gssu Survey 2012

7/18

2012DrugDevInc.

HowmanyNEWtrialsdoyouanticipatestartingupinthenext12-months?

Morethan90%ofthoseworkinginPharma,andalmost80%ofthoseinCROsanticipatenewtrialsto

bestartedupwithinthenext12months .Andsomearebusierthanothers,withjustover20%planning

tostartup3ormoretrialsinthattime.

Howmanysites(onaverage)doyoustart-uppertrial?

Trialsrunbytherespondentsofthesurveytendedtobelarge,withonlyone-thirdofrespondents

indicatingtheaveragenumberofsitestobelessthan50,andafurtherone-thirdindicatingthatthe

averagestudyrequiresmorethan100sitestobestartedup.StudiesrunbyCROstendedtohavea

higheraveragenumberofsitesperstudy.

0%

10%

20%

30%

40%

50%

60%

70%

None 1-2 3-4 5-6 7-8 More

than8

NewStudiesPlanned

Pharma

CRO

0%

10%

20%

30%

40%

50%

800

verageNumberofSitesperTrial

Pharma CRO

7/31/2019 Gssu Survey 2012

8/18

2012DrugDevInc.

SITEIDENTIFICATION

Howdoyouidentifypotentialsitesforyourtrials?

Anumberofkeyoptionswereusedtoidentifypotentialsites,withaheavyrelianceontheuseof

existingcompanydatabases.round85%ofrespondentsusedinternalcompanydatabases ,and

around40%usedanexternaldatabase.Almosttwo-thirdsofCROrespondents,butonlyone-thirdof

Pharma,hadaccesstoaninternalresourcewhoundertooksiteidentificationforthem.Although67%of

PharmarespondentsattemptedtoidentifystudysitesusingaCRO,thesuccessofthisoptionisnot

known,andshouldbeviewedinthecontextthat69%ofrespondentsindicatethattheircurrentlyactive

studiesstillneedmoresitestobeidentified.

Giventhechallengesofsiteidentification,itissurprisingtonotethat only10%ofrespondentssought

assistanceinsiteidentificationfromanon-CROthirdcompany .

Howdoyouidentifypotentialsitesforyourtrials? Pharma CRO

Igetnamesfrommycompany'sinvestigatordatabase 76% 89%

Igetnamesfromexternalinvestigatordatabase(s) 36% 46%

IhaveaninternalsiteIDfunctionthatfindssitesforme 27% 63%

Iuseanon-CROthirdpartytofindsitesformystudies 17% 6%

IuseaCROtofindsitesformystudies

67% 10%

Howlongdoesyoursiteidentificationprocessnormallytake(i.e.togetacompletelistof

investigatorswhohaveexpressedinterestinthestudy)foran"average"studyinan

"average"region?

Thefirststepofsiteidentification,obtainingacompletelistofinterestedinvestigators,appearstobea

slowprocessformost.Thisprocessistaking6ormoreweeksformorethanathirdofrespondents,

withanaveragetimeframeofalmost6weeksforPharma,and5weeksforCROs. Decreasingthetime

forthisinitialstepcouldhavesignificantimpactondownstreamstudydeadlines.

0%10%20%30%40%50%60%

verageSiteIdenAficaAonTime

Pharma

CRO

7/31/2019 Gssu Survey 2012

9/18

2012DrugDevInc.

Howsatisfiedareyouwithyourexistingsiteidentificationmethods?

Two-thirdsofrespondentsreportsatisfactionwiththeirexistingsiteidentificationmethods, fewer

PharmarespondentsreportingsatisfactionthanCROs(59%comparedto70%). Again,thisresultis

surprising,giventhatcurrentmethodstakeanaverageof6weeksfortheinitiallistingofinvestigators,

andthataroundtwo-thirdsofsurveyrespondentsindicatedthattheydonothaveadequatesitesfortheircurrentlyactivestudies.

Whatwouldyouimproveaboutyourcurrentsiteidentificationmethods?

Thissurveyquestionallowedrespondentstoprovidetheircurrentthinkingonwaystoimprovesite

identification.Ofthethemescomingthroughtheseanswers, thetwokeyissueswerespeedand

databasequality.Manyrespondentsexpressedadesiretospeedupthesiteidentificationprocess.

Accesstoareliable,centralizeddatabaseofinterestedinvestigators,categorizedbytherapeuticarea,

wasalsoafrequentrequest.Lastly,severalrespondentswantedtoimprovethequalityofhistorical

informationavailableonsitesnotonlyenrolmentnumbers,butmetricsonretentionandother

indicatorsofsiteperformance.

VeryUnsasfied

SomewhatUnsasfied

Neither

Sasfied

nor

UnsasfiedSomewhatSasfied

VerySasfied

PharmaVery

Unsasfied

SomewhatUnsasfied

NeitherSasfied

norUnsasfied

SomewhatSasfied

VerySasfied

CRO

7/31/2019 Gssu Survey 2012

10/18

2012DrugDevInc.

Doyourcurrentsiteidentificationmethodsprovideyouwithvalueaddedinformation(e.g.

independentratings,pastrecruitmenthistoryetc)toassistyouwithfinalinvestigator

selection?

Inthisquestion,examplesofvalue-addedinformationincludedindependentratingofsitesandpast

recruitmenthistory.Accesstothistypeofinformationwasindependentlynotedbymanyrespondents

asawaytoimprovesiteidentificationmethods.Justoverhalfofrespondentsreportedhavingaccess

tovalue-addedinformationthroughtheircurrentsiteidentificationmethods,withslightlymoreCRO

respondentsindicatingtheydidhaveaccess.Furtherdiscussionofvalue-addedinformationwas

exploredinthefollowingquestion.

0%

20%

40%

60%

80%

100%

Pharma CRO

CurrentccesstoValueddedInformaAon

Unsure

Yes

No

7/31/2019 Gssu Survey 2012

11/18

2012DrugDevInc.

WhichofthefollowingvalueaddedinformationyouNORMALLYandwouldLIKETOreceiveto

assistwithsiteselection?

Forthoserespondentswhodoreceivevalueaddedinformationforsiteselection,nosinglesourceof

valueaddedinformationappearedtobethemostcritical,withrespondentsindicatingtheycurrently

receivearangeofinformation.Asimilarspreadofresponseswasreceivedwhenrespondentswere

askedwhatinformationtheywouldliketoreceive,againreflectingthemulti-faceteddatasourcesused

tomakedecisionsaboutsiteselection.Inbothcases, pastrecruitmenthistorywasconsidered

importantbythehighestnumberofrespondents.

0% 10% 20% 30% 40% 50% 60%

Listofpreviousstudies

Listofprevioustraining

Central/LocalIRB/ethics

Pastperformance-recruitment

Pastperformance-quality

Pastperformance-start-up

CurrentValueddedInformaAon

CRO

Pharma

0% 10% 20% 30% 40% 50% 60%

Listofpreviousstudies

Listofprevioustraining

Central/LocalIRB/ethics

Pastperformance-recruitment

Pastperformance-quality

Pastperformance-start-up

IdealValueddedInformaAon

CRO

Pharma

7/31/2019 Gssu Survey 2012

12/18

2012DrugDevInc.

Doyoufindithardertoidentifyenoughgoodinvestigatorsinsomeregionsthanothers?

Although61%ofrespondentsindicatethatsomeregionsweremoredifficultthanotherstofindgood

investigators,therewasnoclearpatterntoindicateaconsistentlydifficultregion. Furtheranalysis

indicatedthat80%identifiedaregionotherthattheirownasbeingthemostdifficult,perhapsreflecting

difficultiesinidentifyingsuitablesitesacrossinternationalbordersratherthanprofilingaparticularregion.

0% 5% 10% 15% 20% 25% 30%

Asia/Pacific

WesternEurope

EasternEurope/Russia

LanAmerica

NorthAmerica

HardestRegionForSiteSelecAon

7/31/2019 Gssu Survey 2012

13/18

2012DrugDevInc.

STUDYSTART-UP

Howlongdoesthesitestart-upphasenormallytakeforyour"average"studyinan"average"

region?(i.e.fromcompletionofsiteIDtohavingyourtargetnumberofsitescapableof

enrollment.)

Themostcommonresponsetothequestionoftheaveragestudystart-uptimewas3-4months,with

littledifferencebetweenPharmaandCROstudies.Onlyathirdofaveragestudieshadtheirtarget

numberofsitesinitiatedby3months,leaving 63%ofstudiestakingmorethan3months toreachthis

earlymilestone.Longerthan6monthswasreportedtobethetimetostartupanaveragestudyby

10%ofrespondents.

Howsatisfiedareyouwithyourexistingsitestart-upmethods?

Despitethelongdurationsreportedforanaveragestudystart-up,overall62%ofrespondentssaidthey

weresatisfiedwiththeircurrentmethods.Interestingly,thosefrom Pharmawerelesslikelytoreport

satisfactionwiththeirmethods,atonly44%,comparedwith72%ofthosefromCROs.

0% 5% 10% 15% 20% 25% 30%

Lessthan1month

1-2months

2-3months

3-4months

4-5months

5-6months

6+months

verageSiteStart-UpTime

0%

20%

40%

60%

80%

100%

Pharma CRO

SaAsfiedWithCurrentStart-Up

sasfied

notsasfied

7/31/2019 Gssu Survey 2012

14/18

2012DrugDevInc.

Whatwouldyouimproveaboutyourcurrentsitestart-upmethods?

Thissurveyquestionallowedrespondentstoprovidetheircurrentthinkingonwaystoimprovesite

start-upmethods.Ofthethemescomingthroughtheseanswers ,thetwokeyissueswerespeed,and

placinganincreasedfocusontheimportanceofthisstep ,includingadditionalstaffandresourcesinthisphase.Manyofthecommentsrelatingtothespeedoftheprocessexpressedfrustrationwiththe

timetakenforcontractstobenegotiated,particularlywithlargeinstitutions.

Haveyoueverusedacontingentsitestart-upservice?(i.e.aservicethatonlychargesforsites

thatrecruitasubjectwithinapre-agreedtime)

Acontingentstart-upserviceidentifiesandstarts-upsiteswithaguaranteewaivingchargesforsites

thatdonotstarttorecruitwithinagiventime-frame.Althoughthismethodcouldprovideanextremely

usefuloptiontoimprovestudystart-upprogress,veryfewoftherespondentshadeveruseda

contingentstart-upservice,with only13%ofCROsand7%ofPharmarespondentsreportingprevious

use.

Inyourexperience,whatpercentageofsitesmeetorexceedtheirrecruitmenttargets?

Athirdofrespondentsreportlessthan30%ofsitesmeettheirrecruitmenttargets,withonly15%

reportingsuccess70%ofthetime. Theaverageproportionofsitesreachingtheirrecruitmenttargets

wasonly44%.

0%

5%

10%

15%

20%

25%

30%

SiteschievingRecruitmentGoals

Pharma

CRO

7/31/2019 Gssu Survey 2012

15/18

2012DrugDevInc.

THEROLEOFMONITORING

Inyourexperience,whatpercentageofsiteswouldstillmeetorexceedtheirrecruitment

targetsintheabsenceofon-sitemonitoring?

Mostrespondentsbelievedon-sitemonitoringplayedsomeroleinsitesmeetingtheirrecruitmenttargets,with61%indicatingthatlessthan30%ofsiteswouldmeettargetswithoutmonitoring.On

average,respondentsestimatedthat29%ofsiteswouldreachtargetinthisscenario.Only16%

believedthatmorethanhalfoftheirsiteswouldreachrecruitmenttargetswithouton-sitemonitoring.

Inyourexperience,whatpercentageofsiteswouldstillmeettheirrecruitmentandquality

targetsintheabsenceofon-sitemonitoring?

EvenfewerrespondentsfeltthatsiteswouldreachrecruitmentANDqualitytargetsintheabsenceof

on-sitemonitoring,with73%indicatingthatlessthan30%ofsiteswouldmeettargetswithout

monitoring.Onaverage,respondentsestimatedthat 21%ofsiteswouldstillreachrecruitmentand

qualitytargetswithoutonsitemonitoring.

7/31/2019 Gssu Survey 2012

16/18

2012DrugDevInc.

EARLYENGAGEMENT

Doyouthinkearlyengagementofpotentialinvestigators(e.g.beforeaprotocolisfinalized)

canimprovesubjectrecruitmentrates?

Theoverwhelmingmajorityofrespondentsfeltthatearlyengagementcouldhaveapositiveimpacton

recruitmentrates,with84%respondingyes.

Doyouthinkearlyengagementofpotentialinvestigators(e.g.beforeaprotocolisfinalized)

canimprovesubjectrecruitmentrates?

Two-thirdsofrespondentsfeltthatearlyengagementcouldshortenstudystart-uptimes.

Haveyouevercontractedagroupofpotentialinvestigatorsbeforeaprotocolhasbeen

finalizedtoassistwithfinaldesign?

Overall,57%ofrespondentshadcontractedpotentialinvestigatorstofinaliseprotocoldesign,buta

largedifferencewasnotedbetweenPharmaandCRO,with 72%ofPharmaindicatingtheyhad

experiencedthistypeofearlyengagement,butonly48%ofCRO.

0%

20%

40%

60%

80%

100%

Pharma CRO

ExperienceofEarlyEngagement

No Yes Unsure

7/31/2019 Gssu Survey 2012

17/18

2012DrugDevInc.

APPENDIXA:FEASIBILTYSPECIALISTS

Ofthe221surveyresponsesreceived,17werefromfeasibilityspecialists.Duetothespecialisednatureoftheir

work,theirresponsesarereportedseparatelyfromtheProjectManagersandStudyManagers.

Howmanyclinicaltrialsareyouworkingonforfeasibilitystudiesrightnow?None 1

1-2 4

3-4 3

5-6 4

7-8 5

Morethan8 0

Total 17

Howmanyofthesetrialsstillrequirefeasibilitydatatobecollectedfromsites?

None 3

1-2 5

3-4 7

5-6 1

7-8 1

Morethan8 0

Total 17

HowmanyNEWfeasibilityprojectsdoyouanticipateconductinginthenext3-months?

None 1

1-2 3

3-4 2

5-6 1

7-8 0

Morethan8 10

Total 17

Howdoyoufindinvestigatorsforyourfeasibilitysurveys(checkallthatapply)

Isearchmycompany'sinvestigatordatabase 16

Isearchanexternalinvestigatordatabase(s) 11

Iuseanon-CROthirdpartytofind/fieldfeasibilitysurveys 5

IuseaCROtofind/fieldfeasibilitysurveys 5

7/31/2019 Gssu Survey 2012

18/18

2012 DrugDev Inc

Whichofthefollowingbestdescribeshowyourfeasibilitysurveysarenormallyfielded?

EmailInvitation 8

FaxSurvey 4

PaperSurvey 5

Total 17

Onceyouhaveafeasibilitysurveyprepared,howlongdoyounormallyallowtogetthe

responsenumbersyouwantbackfromallinvestigators(inallregions)?

lessthanaweek 1

1-2weeks 4

2-4weeks 9

4-6weeks 3

Total 17

Doyoucompensateinvestigatorsforcompletingaprotocolfeasibility

yes 0

no 15

unsure 2

Total 17

Whichisthemostimportantobjectivetoyouwhenplanningtorunafeasibilitystudy

Costefficiency 1

Speed 2

GlobalReach 3

ValidatedInvestigators 11

Total 17