iqvia -臨床試驗參與者報酬：應對全球復雜性與現(xiàn)代研究 Clinical Trial Participant Payments - Navigating Global Complexity and Modern Studies

QVIA

TECHNOLOGIES

WhitePaper

ClinicalTrialParticipant

Payments:NavigatingGlobal

ComplexityandModernStudies

BySHAUNWILLIAMS,SeniorDirector,ClinicalTrialPaymentsSolutions,IQVIATechnologies

Tableofcontents

Thestatusquoforparticipantpayments:Anoverrelianceonsites2

Managingglobalcomplexity:Aspotlightoncountry-levelchallenges2

Thevalueofglobalreachforclinicalresearch4

Clinicaltrialmanagementhasonlygrownmoreintricateinrecentyears,drivenbyanincreaseofnewmodalities,studymodels,andregulatoryexpectations.Forthesponsorsoverseeingthesestudies,oneofthemostchallengingaspectsoftrialconductismanagingparticipantpayments.Deliveringsiteandinvestigatorpaymentsonscheduleandinfullisoftendifficultinitself;ensuringthat

participantsarealsocompensatedfairlyandinatimelymannercreatesanaddedlayerofcomplexity,particularlyassponsorsworktoscaletheirtrialsglobally.

Compensationhasbeenshowntoactasasignificant

motivatorforpatientstoenrollinclinicaltrials,aswellasforremainingenrolledthroughoutthelifeofthestudy.AccordingtoAvoca’s

360°assessmentoftheclinicaltrial

industry

,publishedin2023,nearly90percentofpatientssurveyedcitedpaymentsasakeyinfluenceontheir

desiretoparticipateinaclinicaltrial.However,justasmanypatientsareoftenuncertainhowparticipatinginaclinicaltrialwillimpacttheirillness,manyarelikewise

waryofwhethertheywillbecompensatedfortheir

efforts:only28%ofrespondentsfromthesamesurveyindicatedthattheybelievecompensationandpaywillbegivenasexpectedinaclinicaltrial.

Themethodsmostoftenemployedformanaging

participantpaymentsplacemostoftheburdenon

trialteams.Thisnotonlycreatesanundueburdenfor

sitesbutcanalsoresultincompoundingissuesasa

sponsorworkstoscaleitspresenceglobally.Regulatorycompliance,bankinginfrastructure,fraudprevention,

dataprivacy,taxlaw—ultimately,themanyshifting

factorsthataccompanyoperatingaglobaltrialnetworkarebestservedbytrulyglobal,comprehensivesolutions,backedbyexpertiseandsupportedbyend-to-end

technologyplatforms.

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Thestatusquoforparticipantpayments:Anoverreliance

onsites

Therearetwocommonapproachestomanaging

participantpaymentsforclinicaltrials.Thefirstisto

placethebulkofthisresponsibilityoninvestigativesites,makingthemtheprimarypointofcontactforpatientsandentrustingthemwithmanagingeveryaspect

ofparticipantcompensation.Thisisoftenachieved

bybuildinginadditionalfeestoasite’sClinicalTrial

Agreement(CTA)budgetandtaskingclinicalteamswithmetingoutparticipantpaymentsoncethey’vereceived

thosefundsfromtheirpaymentprovider.Thissetupisacumbersomeone,and,inanerawheremanyclinicaltrialsitescanaffordtobeselectivearoundthesponsorstheypartnerwith,itcancreatealevelofcomplexitysome

siteswouldratheravoid.

Anoverrelianceonsitestoperformparticipantpayment

managementcan:

?Resultinadditionalsteps/activitiesfortrialteams,

furthercomplicatingtheiralreadyheavyworkloadandforcingthemtoperformworkunrelatedtopatient

care,oreventohireadditionalstaff

?Leadtotrackingpaymentsandinvoicesthat,

submittedincorrectly,cancausecompoundingdelaysanddisincentivizepatients,particularlythosewho

incurexpensesfortravelingtoandfromaclinicalsite

?Createcomplexitybytaskingteamswithnavigatingpatientpaymentsinwaysthatpassregulatorymuster

?Createcashflowproblemsforsitesthatfrontdelayedpatientpaymentsusingtheirownfunds(andleave

thosewithoutaccesstoadditionalcashwithnomeansofreadilypayingparticipants)

Thesecondapproachfrequentlyundertakenin

managingparticipantpaymentsalsoplacesmuchoftheburdenoninvestigatorteams,withatechnologicalbufferintheformofathird-partypaymentplatform.Inthisscenario,sponsorsidentifyacompany—or,

morefrequently,companies—thathavecapabilitiesinthecountriesinvolvedinatrialtoactasvendorforsites,providingthemaplatformtomanagepaymentsbutrelegatingtheadministrativeworktositeteams.Thisincludesmanagingtheforminwhichpaymentsaredisbursed(oftenareloadabledebitcard)thattrialteamsmustissuetopatientsandmanagethroughoutthestudy.

Forcingsitestomanageeveryaspectofthesepayments—fromreplacinglostcardstosafeguardingpaymentsandfreezinglostorstolencards—meansthatthese

solutionsoftendolittletoalleviatetheburdenof

paymentmanagementfortrialsites.Thisapproachis

alsoone-size-fits-all,andparticipantsaregivennootheroptionsforhowtheywishtoreceivepayments,which

maydisincentivizesomeparticipants,particularlyif

issueswithpaymentsoccur.Inaclinicaltriallandscapesetonsimplifyingthestudyexperienceforbothpatientsandsites,theseapproachesarefarfromoptimalandcanrunupagainstsignificantroadblocksincertaincountriesorregionswheremorecalibratedapproachesare

neededtomeetlegalandregulatoryrequirements.

Managingglobalcomplexity:Aspotlightoncountry-

levelchallenges

Whilethereareahandfulofcountrieswhereconductingclinicalresearchismadevirtuallyimpossiblebylaw,

politicalclimate,ormedicalaccess,therearemanyothersthatarewell-positionedtoaddvaluetoa

studybutrequireadditionalexpertiseorsupportto

incorporateintoatrialorprogram.Theselocationsare

oftenhometodiversepatientpopulations,premier

medicalinstitutions,andintegralinfrastructure,but

intricaciesinbroaderlawsorregulatorystandardscanmakethemtoughertonavigateforsponsorswithouttherightsupport.

Hereareafewexamplesofsomeofthestumblingblockssponsorscanencounteraroundtheglobe:

2|ClinicalTrialParticipantPayments:NavigatingGlobalComplexityandModernStudies

China:Forthosestrugglingwith

recruitment,placeslikeChinacan

representauniqueopportunitywithitsvastpopulationoftreatment-na?ve

patients,manyofwhomsufferfromindicationsWesterncountriesareeagertoaccessfortheirtrials.Conducting

trialsinChinacanbeequallyattractiveforitsrelative

costeffectiveness

—directcostsfortrialsinChinaare

estimatedtobeapproximately30percentlowerthan

thoseinWesterncountries.Moreover,recentregulatoryreformshavestreamlinedapprovalsandimprovedclinicaltrialinfrastructure,togetherbolsteringChina’sstatusasanemergingclinicaltrialleader.

So,whatarethelimitationstoconductingastudyintheworld’smostpopulousnation?Hereareafew:

Regulatoryoversightandethical

considerations:Chinaboastsastringentregulatoryenvironment,anditsNational

MedicalProductsAdministration(NMPA)

requires

detaileddocumentationandlengthyapproval

processes

,whichcansignificantlydelaypayments

Anti-briberylawsanddataprivacy:

China’santi-briberylawsarelikewise

rigorousandrequirecarefulscrutiny

aroundthestructureandformatofparticipant

paymentstoskirtlegalissues.Anotherbigpotentialcomplicationcentersonthenation’sdataprivacy

laws,whichimposestrictrulesonhowpersonaldata,includingpaymentinformation,canbe

handled,servingtocomplicatethelogisticsofparticipantpayments

Limitedpaymentstructuresand

cybersecurityconcerns:WhileChina’s

digitalpaymentsystemsareadvanced,

it

isoftendifficult

tointegratethemwithinternationalclinicaltrialpaymentsolutions.Additionally,

China’scybersecuritylawsarenotoriouslystrict,necessitatingsignificantexpertisetonavigatethisaddedcomplexityandsupportrobustdatastoragesolutions

Brazil:Brazilisanothercountrythat

offerssponsorsagreatvalueproposition—itsdiversepatientpopulationand

representativediseaseprevalence,coupled

withacomparativelyhighenrollmentandretention

rateforclinicaltrials,makeitanattractiveoptionontheglobalstage.However,challengesrelatedtoregulation,law,anddigitalandfiscalinfrastructurecanbehardtosurmountwithouttherightexpertise.

Theseinclude:

Complexapprovals:Historically,

Brazilhasrequiredtwolevelsof

approvalforclinicaltrials—onefrom

localethicscommitteesandanotherfromtheNationalResearchEthicsCommission(CONEP).

Whilethegovernmenthasattemptedtoaddressthiscomplexity

throughrecentlegislation

,thetransitionwillstilllikelyrequiresignificantlocalexpertisetosurmountlingeringchallenges

Compensationandpost-trial

access:Newlawsaroundparticipant

compensationthatcurtail

compensationorincentivizationoutsideofPhaseItrialsrequirecarefulnavigationonthepartof

sponsors.Additionally,Brazilianlawmandatesthatclinicaltrialparticipants

haveaccessto

investigationalmedications

post-trialuntiltheybecomeavailablethroughregulatoryapproval

Participantpaymentsanddata

privacy:Thoughitsbankingsystems

arerelativelyadvanced,integratinginternationalpaymentsystemsfortrialsinBrazilcanbedifficultwithsomelocalinfrastructures.

Othertechnologicalchallengesrelatedtodataprivacylikewisenecessitatestringentdata

handling,includingforpaymentinformation

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Bulgaria:Akeyadvantageofconducting

clinicaltrialsinBulgariaisitsfocuson

enablingefficientpatientrecruitment;

moreover,

itscentralizedhealthcaresystem

andlarge,specializedmedicalcenters

servetofurtherstreamlinestudyconduct.Italsoboastslowerper-patientcoststhanmanyWesterncountries,cementingitasavaluableresourceforglobalclinicaltrialprograms.

Yetaswithmanyemergingclinicalresearchdestinations,thereremainstumblingblockstoparticipantpayments.

Theseinclude:

Complexapprovalsandethicalreview:

WhileBulgariafollowsEUClinical

TrialsRegulationNo.536/2014,this

harmonization

requiresdetaileddocumentation

andapproval

fromboththeBulgarianDrugAgency(BDA)andthecentralethicscommittee,which

candelaypayments.EthicalreviewinBulgariaisalsorigorous,requiringthoroughassessmentsfromitsethicscommitteeandaddingtimetotheapprovalprocess

Dataprivacyandfinancialregulations:

BulgariaadherestotheEUGeneralData

ProtectionRegulation(GDPR),which

imposesstrictrequirementsonhandlingpersonaldatasuchaspaymentinformation.Itsfinancial

systemisalsohighlyregulatedtopreventmoneylaunderingandfraud,resultinginthepotentialforadditionalscrutinyforcompensatingparticipants

Systemintegrationandcybersecurity:

Bulgaria’sbankingsystemisalsoadvanced

andwell-regulated,but,aswithBrazilandothercountries,integratinginternationalpaymentsystemswithlocalinfrastructure

canbechallenging.Bulgaria’sadherencetoEUcybersecuritylawsislikewisestringent,necessitatingafocusondataprotection

Thesolutionstothesehurdles—relationship-buildingwithregulators,adequatedocumentationofpaymentpractices,robustcybersecurityproto