AQC 2016 Patient Centered Survey FINAL 10252016theavocagroup.com/.../2017/04/AQC-2016-Patient-Centered-Survey-R… · AQC 2016 Survey Research Final Report of Patient Survey and AQC

AQC2016SurveyResearch

FinalReportofPatientSurveyandAQCMemberSurveyData

October2016

UsageGuidelines

Proprietary&Confidential– NoreproductionoftheinformationinthisreportmaybemadewithouttheexpresspriorwrittenconsentofTheAvocaGroup.Allinquiriesandrequestsforconsentforreproductionanduse,includingintegratingelementsofthisreportintotherecipients’ownworkproducts(e.g.,presentations),shouldbedirectedtoLakshmiSundarviaemailatLakshmi.Sundar@theavocagroup.com.

Introduction:2016AQCSurveyPrograms

Introduction

• The2016AQCSurveyResearchProgramhadtwocomponents– AQC’sfirstPatientSurvey,andanabbreviatedversionoftheannualMemberSurvey.InclusionofthePatientSurveyin2016wasrelatedtoAQC’sobjectivetounderstandclinicalresearchquality,andhowitmightbeimproved,fromtheviewpointofallkeystakeholders.

• TheoverallobjectivesoftheAQCPatientSurveyweretogainanunderstandingof:

– theextenttowhichpatientsperceivethattheirmedicalcareprovidersunderstandvariousaspectsofthepatientexperience,

– patientperceptionsof“quality”andvalueinclinicalresearch,aswellasactionsbyresearchersthatmightpositivelyandnegativelyimpacttheseperceptions,and

– factorsthatdrivepatients’desirestoparticipateandcontinueinclinicaltrials.

• Theobjectiveofthe2016AQCMemberSurveywastoexaminequalitytopicsinamannerthatparalleledthePatientSurvey,aswellastocontinuetofollowMemberperceptionsofkeyqualityindicatorsovertime.

Methodology:PatientSurvey

Introduction

• ThePatientSurveywasaweb-basedsurveyofadults(≥18yearsold),UnitedStatesresidentswhoself-identifiedas“patients”withanymedicalconditionandwhocouldread,understand,andcompleteaweb-basedsurveyintheEnglishlanguage.Thestudyrecruited582peoplefittingthisdescription.

• PotentialparticipantswerecontactedbyemailusingemailaddressesfromthePMGResearch,PLM(PatientsLikeMe),andCISCRP(CenterforInformationandStudyonClinicalResearchParticipation)databases,aswellastheAQCMembership.Allcontactsweremadebytheoriginatingorganizations;therewasnotransferofemailaddressesoranyotherpotentiallyidentifyingpatientinformationtootherorganizations(includingTheAvocaGroup),aspartofthisresearch,norwasanypotentiallyidentifyinginformationgatheredduringthesurveyprocess.

• Thisminimal-riskresearchprojectwasreviewedbyWIRBandgrantedexemptstatus.

Methodology:AQCMemberSurvey

Introduction

• TheAQCMembersurveywasaweb-basedsurveyofSponsorandCROAvocaQualityConsortiumMembers.

• Atotalof188respondentscompletedthesurvey,amongkeyaudiencesasfollows:

– 103fromSponsororganizations

– 85fromCROs

• AllsurveyswerecompletedbetweenMarchandJuneof2016.

CharacteristicsofthePatientSample

19%6% Married/domesticpartner

Divorced/separated

Single

Widow/widower

Thesamplewaspredominantlyfemale,and82%ofparticipantswereoverage45.Approximatelyhalfofrespondentswerelivinginmarriages/domesticpartnerships,andthevastmajority(84%)residedintheEasternorMidwesternUS.

CharacteristicsofPatientSample:Demographics

West,Southwest

Mountain

Midwest

Northeast

Southeast

MaritalStatus

27%Female

5% 18to30

31to45

46to60

61to75

AgeRegionwithintheUS

CharacteristicsofPatientSample:MedicalConditions

29%59%

Temporary(expectittogoawaycompletelyatsomepoint)Episodic(comesandgoes)Degenerative(getsworseovertime)Chronic(alwaysthere)butstableDon’tknow

Itvariesalotovertime

Moderate

Severe

Don’tknow

Howoftendoyouseethedoctorresponsiblefortreatingyourcondition?

48%20%

9%10% Onceperyearorless

2to4timesperyear

5to12timesperyear

Morethan12timesperyear

Itdepends

Can'trecall

Themajorityofrespondentsreportedchronicordegenerativemedicalconditions,andmostexperiencedmoderateorsevereimpactsontheirlives.Abouttwo-thirdssawtheirtreatingdoctorsbetween2and12timesperyear.

ImpactofMedicalCondition

TypeofMedicalCondition

32%Fulltime

Parttime

Retired

11% Advanceddegree

Completedcollegedegree

Somecollege

Completedhighschool

Somehighschool

Respondentswerelargelywell-educated,withmorethanhalfpossessingacollegedegree.Approximatelyathirdwereemployed,one-quarterfull-time.Slightlyunderhalfwererelieduponbyfamilymembersfordirectcareorfinancialsupport.

CharacteristicsofPatientSample:EducationandEmployment

Doyouhavefamilymembersforwhomyouprovidecareorfinancialsupport?

HighestLevelofEducation

Areyoucurrentlyemployed?

CharacteristicsoftheAQCMemberSample

CharacteristicsofAQCMemberSample:Companies

Sponsors103respondentsfrom27Membercompanies

#ofrespondentspercompanyrangedfrom1to11

CROs85respondentsfrom6Membercompanies

#ofrespondentspercompanyrangedfrom5to32

Alexion Horizon

Alnylam Infinity

Amgen MitsubishiTanabePharma

Astellas Novartis

Biogen Pfizer

BoehringerIngelheim Pharmacyclics

BristolMyersSquibb Purdue

CSLBehring Raptor

Cidara Roche

EliLilly SeattleGenetics

Endocyte Shire

GlaxoSmithKline Sunovion

GileadSciences Theravance

Grünenthal

Chiltern

Covance

INCResearch

Sponsorrespondentsrepresentedcompaniesofvaryingsize,whileCROrespondentswerecomprisedofLargeandMid-sizedCROs.AmajorityofrespondentsfrombothSponsorsandCROsrepresentedcompaniesheadquarteredintheUnitedStates,withtheremainderprimarilyinWesternEurope.

CharacteristicsofAQCMemberSample:CompanySize&Location

19%1%2% UnitedStates

WesternEurope

Sponsors CROs

15%17%

Top20Biopharma($10+Bsales)Top50/Mid-sizedBiopharma($1.0-$9.9Bsales)OtherMid-sizedBiopharma($500-$999Msales)Small/SpecialtyBiopharma(<$500Msales)Other

27%2% UnitedStates

WesternEurope

LargeCRO($1+Brevenue)

Mid-sizedCRO($100-$999Mrevenue)

Small/SpecialtyCRO(<$100Mrevenue)

ThesamplewaslargelycomposedofrespondentsrepresentingtheClinicalDevelopment/Operationsfunctionoftheirorganizations,followedbyQualityAssurance/QualityControl.

CharacteristicsofAQCMemberSample:RespondentRoles

Sponsors CROs

ClinicalDevelopment/Operations

Procurement/Outsourcing/VendorManagementRegulatoryAffairs

Medical/Scientific

ExecutiveManagement

QualityAssurance/QualityControl

12%4%7%

ClinicalDevelopment/Operations

BusinessDevelopment

AllianceManagement/Partnerships

Medical/Scientific/Regulatory

ExecutiveManagement

QualityAssurance/QualityControl

N=102 N=84

ApproximatelyhalfofrespondentsfromSponsororganizationsindicatedthattheyutilizeamixoffull-serviceandfunctionaloutsourcingforclinicaldevelopment,followedbyprimarilyusingafunctionalproviderandprimarilyutilizingafull-serviceapproach.

CharacteristicsofAQCMemberSample:OutsourcingModels

23%58%

Primarily(>80%)full-serviceoutsourcing

Primarily(>80%)functionaloutsourcing

Mixoffull-serviceandfunctionaloutsourcing

Sponsors’OutsourcingModels

PatientViewsonUnderstandingof

theirConditionsbyHealthcareProviders

Onaverage,patientswerenotveryimpressedwiththeirhealthcareproviders’understandingofwhatit’sliketobeapatientwiththeirconditions.Meansinthissectionofthesurveyrangedfrom2.9to3.4onascaleof1(understandsnotatall)to5(understandsverywell),andforeachquestion,between26%and39%ofpatientsgavearatingof1or2.

PatientViewsonUnderstandingoftheirConditionsbyProviders

Scaleof1(notatall)to5(verywell).Ifyouseemorethanonehealthcareproviderforyourcondition,andifyouropinionsregardingthemaredifferent,pleaserespondforthehealthcareproviderwhoyouseemostoften.

What’smostimportanttoyouinatreatment

Thesymptomsthatbotheryouthemost

Allofthedifferentkindsofsymptoms

Whatsideeffectsyouexperience

Typeofpain/discomfort

Amountofpain/discomfort

Whatyouworryaboutinatreatment

Worklifeandabilitytomakealiving

1- Notatall 2 3 4 5- Verywell

Mean N

3.4 497

3.4 515

3.4 512

3.3 501

3.3 486

3.3 493

3.2 445

Howwelldoyoubelievethatyourdoctor(s)andnurse(s)understandwhatit’sliketobeapatientwithyourcondition,ineachofthefollowingways?

Patientswereonaveragemostlikelytofeelthattheirprovidersunderstoodtheirsymptomsandtreatmentpreferences,butwerelesslikelytoperceivethattheirprovidersunderstoodtheimpactsoftheirconditionsontheirlivesandparticularlyontheirfamilyrelationshipsandabilitytocareforchildren.

PatientViewsonUnderstandingoftheirConditionsbyProviders

Howyourothermedicalconditions(besidesthisone)affectyou

Abilitytoperformbasictasksofliving(hygiene,housework,etc.)

Abilitytotakepartinactivitieswithfriendsandinthecommunity

Howthecostaffectsyou

Howtheinconvenienceordiscomfortaffectsyou

Mentalhealth/emotionalstate(e.g.Happiness,worry,stress)

Relationshipwithyourspouse/partner

Relationshipwithandabilitytocareforyourchildren

1- Notatall 2 3 4 5- Verywell

Howwelldoyoubelievethatyourdoctor(s)andnurse(s)understandwhatit’sliketobeapatientwithyourcondition,ineachofthefollowingways?

Scaleof1(notatall)to5(verywell).Ifyouseemorethanonehealthcareproviderforyourcondition,andifyouropinionsregardingthemaredifferent,pleaserespondforthehealthcareproviderwhoyouseemostoften.

Mean N

3.2 470

3.2 497

3.1 497

3.1 487

3.1 503

3.0 511

3.0 370

2.9 255

ThemesinOpen-EndedCommentsPatientViewsonUnderstandingoftheirConditionsbyProviders

• No-onecanrelatetopain/fatigue/symptomslikethis,andtheirimpacts,unlesstheyhaveexperienceditthemselves

• Lackof“vocabulary”and/orself-trackingtoappropriatelyconveyexperiencetoproviders

• Providersaretoobusytotrytounderstandallofthesethings

– Briefvisitsforcepatientstoconveyonly“1or2topsymptoms;”focuson“abilitytoworkformoney”concernsatexpenseof“abilitytoplay”orfamilyconcerns

• Notproviders’jobtounderstandthesethings,notpartofmedicine

• Prescribingpatternsdonottakeintoaccountpatientpreferencesre.tradingasymptomforasideeffectorrisk;donothonortreatmentrefusals

• Doctorsfailtotrackcharts/histories,onlygrasp“what’sgoingonnow”

• Specialistcaremeansthateachdoctoronlyunderstandsonepartofthepatient

• Patientspurposefullydon’tsharethisinformation(seelaterslides)

• Prescribingpatterns(tests,treatments,referrals)demonstratefailuretounderstandlogisticsandstressofgettingcare,i.e.transportationconcerns,financialconcerns,insurancehassles,timeoffofwork

Onaverage,patientswithchronicconditionsfeltmostunderstoodbytheirproviders.Thosewithdegenerativeconditionsfeltleastunderstoodwhenitcametomostaspectsofdisease,butthosewithepisodicconditionsfeltleastunderstoodwithrespecttoimpactsontheirrelationshipsandabilitytofunctionatwork,athome,andinthecommunity.

PatientViewsonUnderstandingbyProviders:ByTypeofCondition

Meanratingsofperceivedunderstandingonascaleof1(notatall)to5(verywell)

Chronicbutstable Degenerative Episodic

What’smostimportanttoyouinatreatment 3.6 3.2 3.3Thesymptomsthatbotheryouthemost* 3.5 3.3 3.4Allofthedifferentkindsofsymptoms 3.5 3.2 3.4Whatsideeffectsyouexperience 3.4 3.2 3.5Typeofpain/discomfort* 3.4 3.1 3.2Amountofpain/discomfort 3.4 3.2 3.3Whatyouworryaboutinatreatment 3.4 3.2 3.2Worklifeandabilitytomakealiving* 3.3 3.2 2.7Howyourothermedicalconditions(besidesthisone)affectyou 3.3 3.0 3.1Abilitytoperformbasictasksofliving(hygiene,housework,etc.)* 3.2 3.2 2.9Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.2 3.2 2.9Howthecostaffectsyou 3.2 3.1 3.2Howtheinconvenienceordiscomfortaffectsyou 3.1 3.0 3.2Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 3.1 3.1 3.1Relationshipwithyourspouse/partner 3.1 2.9 2.7Relationshipwithandabilitytocareforyourchildren* 3.0 3.0 2.3

Nrange= 149-299 70-152 25-47

PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyTypeofMedicalCondition(onlycategorieswithN>10)

Note:Highestmeanperrowhighlightedinyellow,lowestinred;*p<.05(unadjustedformultipletests)

Meanratingsofperceivedunderstandingonascaleof1(notatall)to5(verywell) Severe Moderate Mild Itvaries None

What’smostimportanttoyouinatreatment 3.3 3.4 3.8 3.6 3.2Thesymptomsthatbotheryouthemost** 3.2 3.4 3.8 3.5 3.2Allofthedifferentkindsofsymptoms** 3.2 3.4 3.9 3.3 3.3Whatsideeffectsyouexperience 3.3 3.3 3.6 3.3 3.2Typeofpain/discomfort 3.2 3.3 3.6 3.4 2.9Amountofpain/discomfort* 3.1 3.3 3.7 3.3 3.0Whatyouworryaboutinatreatment 3.2 3.2 3.5 3.4 3.0Worklifeandabilitytomakealiving 3.3 3.1 3.2 3.0 2.8Howyourothermedicalconditions(besidesthisone)affectyou 3.0 3.2 3.4 3.1 3.2Abilitytoperformbasictasksofliving(hygiene,housework,etc.) 3.1 3.2 3.3 3.2 2.6Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.2 3.1 3.2 3.1 2.7Howthecostaffectsyou 3.1 3.0 3.4 3.2 3.2Howtheinconvenienceordiscomfortaffectsyou 3.0 3.0 3.4 3.1 3.0Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 3.0 3.0 3.2 3.1 2.7Relationshipwithyourspouse/partner 3.0 2.9 3.4 2.9 2.6Relationshipwithandabilitytocareforyourchildren 2.9 2.9 2.9 3.1 2.4

Nrange= 77-159 87-181 37-80 35-63 18-35

PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyImpactofMedicalCondition

Onaverage,patientswithmilddiseaseimpactsfeltmostunderstoodbytheirproviders.Thoseattheextremesofthespectrum– withnoimpactorwithsevereimpact– feltleastunderstoodwhenitcametomostaspectsofdisease.

PatientViewsonUnderstandingbyProviders:ByImpactofCondition

Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01(unadjustedformultipletests)

Patientswithhigh“touchrates”withtheirdoctorswerenomorelikelytofeelunderstoodthanwerepatientswithlessfrequentcontact.

PatientViewsonUnderstandingbyProviders:ByFrequencyofCare

5to12times

peryear

2to4times

peryear

Onceperyearorless

Itdepends

What’smostimportanttoyouinatreatment 3.1 3.4 3.5 3.4 3.5Thesymptomsthatbotheryouthemost 3.4 3.2 3.5 3.4 3.4Allofthedifferentkindsofsymptoms* 3.4 3.1 3.6 3.5 3.3Whatsideeffectsyouexperience 3.2 3.3 3.5 3.1 3.4Typeofpain/discomfort 3.3 3.2 3.4 3.3 3.2Amountofpain/discomfort 3.3 3.2 3.4 3.3 3.2Whatyouworryaboutinatreatment 3.1 3.3 3.4 3.0 3.5Worklifeandabilitytomakealiving 3.4 3.2 3.2 3.1 3.0Howyourothermedicalconditions(besidesthisone)affectyou 3.2 3.0 3.2 3.3 3.1Abilitytoperformbasictasksofliving(hygiene,housework,etc.) 3.0 3.1 3.2 3.3 3.0Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.1 3.1 3.2 3.0 3.1Howthecostaffectsyou 2.7 3.1 3.3 3.0 3.0Howtheinconvenienceordiscomfortaffectsyou 3.0 3.1 3.1 3.0 3.1Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 3.1 2.8 3.1 3.1 2.9Relationshipwithyourspouse/partner 3.0 2.9 3.1 2.8 2.8Relationshipwithandabilitytocareforyourchildren 2.9 2.9 2.9 2.8 2.8

Nrange= 34-53 52-104 116-251 25-60 27-53

PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyFrequencyofCare

Patientswhowererelieduponbyfamilymembersfordirectcareand/orfinancialsupportwerelesslikelythanotherstofeelwell-understoodbytheirmedicalcareproviders,whenitcametonearlyeveryaspectoftheirconditionsandlives.

PatientViewsonUnderstandingbyProviders:ByFamilyResponsibility

Yes (providescareorfinancial supporttofamilymembers)

What’smostimportanttoyouinatreatment 3.4 3.5Thesymptomsthatbotheryouthemost*** 3.2 3.6Allofthedifferentkindsofsymptoms*** 3.2 3.6Whatsideeffectsyouexperience 3.2 3.4Typeofpain/discomfort** 3.1 3.4Amountofpain/discomfort** 3.1 3.4Whatyouworryaboutinatreatment 3.2 3.3Worklifeandabilitytomakealiving 3.2 3.2Howyourothermedicalconditions(besidesthisone)affectyou** 3.0 3.3Abilitytoperformbasictasksofliving(hygiene,housework,etc.) 3.1 3.2Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.1 3.2Howthecostaffectsyou 3.1 3.2Howtheinconvenienceordiscomfortaffectsyou 3.0 3.2Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 2.9 3.1Relationshipwithyourspouse/partner 3.0 3.0Relationshipwithandabilitytocareforyourchildren 2.8 2.9

Nrange= 144-217 110-297

PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyFamilyResponsibility

Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005(unadjustedformultipletests)

Employedpatientswerelesslikelythanotherstofeelthatthefunctionalaspectsoftheirconditionswerewell-understoodbytheirproviders.Thosewhoworkedfull-timewereleastlikelytofeelthatthecost,theinconvenience,andotherworriesabouttreatmentswerewell-understood.Unemployedpatientswereleastlikelytofeelthattheirpain/discomfortandothersymptomswerewell-understood.

PatientViewsonUnderstandingbyProviders:ByEmploymentStatus

Meanratingsofperceivedunderstandingonascaleof1(notatall)to5(verywell) Fulltime Parttime Retired No

What’smostimportanttoyouinatreatment 3.4 3.6 3.5 3.4Thesymptomsthatbotheryouthemost 3.4 3.4 3.5 3.3Allofthedifferentkindsofsymptoms 3.5 3.5 3.5 3.3Whatsideeffectsyouexperience 3.4 3.6 3.2 3.4Typeofpain/discomfort 3.3 3.5 3.4 3.2Amountofpain/discomfort 3.4 3.3 3.4 3.1Whatyouworryaboutinatreatment 3.1 3.3 3.3 3.4Worklifeandabilitytomakealiving 3.0 3.0 3.2 3.4Howyourothermedicalconditions(besidesthisone)affectyou 3.4 3.1 3.2 3.0Abilitytoperformbasictasksofliving(hygiene,housework,etc.) 3.1 3.1 3.2 3.2Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.0 3.0 3.2 3.2Howthecostaffectsyou 3.0 3.2 3.2 3.2Howtheinconvenienceordiscomfortaffectsyou 3.0 3.1 3.2 3.1Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 3.0 2.9 3.0 3.2Relationshipwithyourspouse/partner 2.9 3.0 3.0 3.1Relationshipwithandabilitytocareforyourchildren 2.9 3.0 2.7 3.0

Nrange= 69-131 35-64 62-154 88-171

PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyCurrentEmployment

Patientswhohadparticipatedinclinicaltrialsweremorelikelythanotherstofeelwell-understoodbytheirmedicalcareproviderswhenitcametonearlyeveryaspectoftheirconditionsandlives,theonlyexceptionsbeingtheimpactsoftheirconditionsonfamilyrelationships.

PatientViewsonUnderstandingbyProviders:ByHistoryofTrialParticipation

Meanratingsofperceivedunderstandingonascaleof1(notatall)to5(verywell) Yes No

What’smostimportanttoyouinatreatment 3.6 3.3Thesymptomsthatbotheryouthemost* 3.5 3.3Allofthedifferentkindsofsymptoms* 3.6 3.3Whatsideeffectsyouexperience* 3.5 3.2Typeofpain/discomfort 3.4 3.2Amountofpain/discomfort* 3.4 3.2Whatyouworryaboutinatreatment 3.4 3.2Worklifeandabilitytomakealiving 3.3 3.1Howyourothermedicalconditions(besidesthisone)affectyou 3.2 3.1Abilitytoperformbasictasksofliving(hygiene,housework,etc.) 3.3 3.1Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.2 3.1Howthecostaffectsyou 3.2 3.1Howtheinconvenienceordiscomfortaffectsyou 3.2 3.0Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 3.1 3.0Relationshipwithyourspouse/partner 3.0 3.0Relationshipwithandabilitytocareforyourchildren 2.9 2.9

Nrange= 92-214 163-302

PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyHaveEverParticipatedinaClinicalTrial

Olderpatientsweremostlikelytofeelwell-understoodbytheirmedicalcareproviderswhenitcametonearlyeveryaspectoftheirconditions,theexceptionbeingthesideeffectsoftreatments(theNforthe76+agegroupwassmall,butthetrendoftenextendedtothe61-75agegroup).Patientsbetweenages31-45wereleastlikelytofeelunderstood.Thesetrendsmayrelatetothoseshowninpreviousslidesregardingtypesofconditionsexperienced,employmentstatus,familyresponsibilities,etc.

PatientViewsonUnderstandingbyProviders:ByAgeGroup

Meanratingsofperceivedunderstandingonascaleof1(notatall)to5(verywell) 76+ 61-75 46-60 31-45 18-30

What’smostimportanttoyouinatreatment 4.0 3.5 3.4 3.2 3.5Thesymptomsthatbotheryouthemost** 4.0 3.6 3.4 2.9 3.4Allofthedifferentkindsofsymptoms*** 3.9 3.6 3.4 2.9 3.6Whatsideeffectsyouexperience 3.5 3.4 3.4 3.1 3.8Typeofpain/discomfort* 3.8 3.5 3.2 2.9 3.5Amountofpain/discomfort** 3.8 3.5 3.2 2.9 3.2Whatyouworryaboutinatreatment* 4.1 3.4 3.3 3.0 3.3Worklifeandabilitytomakealiving 3.8 3.2 3.3 2.9 2.9Howyourothermedicalconditions(besidesthisone)affectyou 3.3 3.3 3.2 3.0 2.9Abilitytoperformbasictasksofliving(hygiene,housework,etc.)** 3.5 3.3 3.2 2.6 3.2Abilitytotakepartinactivitieswithfriendsandinthecommunity* 3.3 3.3 3.1 2.7 3.1Howthecostaffectsyou** 3.8 3.3 3.0 2.6 3.4Howtheinconvenienceordiscomfortaffectsyou 3.4 3.2 3.0 2.8 3.1Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 3.5 3.2 3.1 2.7 3.2Relationshipwithyourspouse/partner 3.5 3.1 3.0 2.6 3.2Relationshipwithandabilitytocareforyourchildren 4.0 2.9 2.9 2.5 3.7

Nrange= 5-18 78-185 96-183 44-71 6-14

PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyAge

Whenitcametosymptoms,particularlypain,femalesonaveragefeltlessunderstoodbymedicalcareprovidersthandidmales.Thiswasalsotruefortreatmentpreferencesandforimpactsonbasictasksofdailylivingandrelationships,althoughthedifferencesintheseareasweresmaller.Malesfeltslightlylessunderstoodthanfemaleswhenitcametoimpactsonworklifeandsideeffects.

PatientViewsonUnderstandingbyProviders:BySex

Meanratingsofperceivedunderstandingonascaleof1(notatall)to5(verywell) Female Male

What’smostimportanttoyouinatreatment 3.4 3.6Thesymptomsthatbotheryouthemost 3.4 3.6Allofthedifferentkindsofsymptoms* 3.3 3.6Whatsideeffectsyouexperience 3.4 3.3Typeofpain/discomfort 3.2 3.5Amountofpain/discomfort 3.2 3.5Whatyouworryaboutinatreatment 3.3 3.3Worklifeandabilitytomakealiving 3.2 3.1Howyourothermedicalconditions(besidesthisone)affectyou 3.1 3.3Abilitytoperformbasictasksofliving(hygiene,housework,etc.) 3.1 3.2Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.1 3.1Howthecostaffectsyou 3.1 3.1Howtheinconvenienceordiscomfortaffectsyou 3.1 3.1Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 3.0 3.1Relationshipwithyourspouse/partner 2.9 3.0Relationshipwithandabilitytocareforyourchildren 2.8 2.9

Nrange= 167-340 59-121

PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebySex

Ingeneral,patientswhoaresingleormarried/partneredfeelmostunderstoodbytheirmedicalcareproviders,whereasthosewhoaredivorced/separated,orparticularlywidowed,feelleastunderstood.Thedifferencesacrossgroupswereagainmorepronouncedforimpactsonrelationshipsthanforthemoreclinicalaspectsofthecondition.

PatientViewsonUnderstandingbyProviders:ByMaritalStatus

Married/domesticpartner

Divorced/separated Single Widow/

widower

What’smostimportanttoyouinatreatment 3.5 3.3 3.6 3.3Thesymptomsthatbotheryouthemost 3.5 3.3 3.5 3.0Allofthedifferentkindsofsymptoms 3.5 3.3 3.5 3.0Whatsideeffectsyouexperience 3.4 3.3 3.5 3.1Typeofpain/discomfort 3.4 3.1 3.5 3.1Amountofpain/discomfort 3.4 3.1 3.4 3.0Whatyouworryaboutinatreatment 3.3 3.2 3.4 3.3Worklifeandabilitytomakealiving 3.2 3.0 3.3 3.4Howyourothermedicalconditions(besidesthisone)affectyou* 3.3 2.9 3.3 2.7Abilitytoperformbasictasksofliving(hygiene,housework,etc.) 3.2 3.1 3.3 2.8Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.2 3.1 3.2 2.8Howthecostaffectsyou 3.2 2.9 3.1 3.0Howtheinconvenienceordiscomfortaffectsyou 3.2 2.8 3.3 2.8Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 3.1 3.0 3.1 2.8Relationshipwithyourspouse/partner 3.1 2.8 3.0 2.3Relationshipwithandabilitytocareforyourchildren 2.8 2.9 3.1 2.1

Nrange= 129-249 49-101 36-86 8-31

PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyMaritalStatus

Ingeneral,therewasatrendtowardaninverserelationshipbetweeneducationalattainmentandperceptionsofunderstanding.Thismayreflectpatternsofcarereceived(i.e.,ruralone-doctorvs.urbanmulti-doctor,migrationpatternsoverlifetime,etc.)and/orthetrustplacedinproviders.

PatientViewsonUnderstandingbyProviders:ByEducationalAttainment

Advanceddegree

Somecollege

Completedhighschool

What’smostimportanttoyouinatreatment 3.4 3.4 3.4 3.4Thesymptomsthatbotheryouthemost 3.3 3.5 3.4 3.5Allofthedifferentkindsofsymptoms 3.4 3.6 3.4 3.2Whatsideeffectsyouexperience 3.4 3.3 3.3 3.5Typeofpain/discomfort 3.3 3.4 3.2 3.4Amountofpain/discomfort 3.3 3.4 3.2 3.4Whatyouworryaboutinatreatment* 3.2 3.2 3.3 3.6Worklifeandabilitytomakealiving 3.1 3.3 3.1 3.3Howyourothermedicalconditions(besidesthisone)affectyou 3.1 3.3 3.1 3.3Abilitytoperformbasictasksofliving(hygiene,housework,etc.) 3.2 3.1 3.1 3.3Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.0 3.0 3.2 3.3Howthecostaffectsyou 3.1 3.0 3.2 3.1Howtheinconvenienceordiscomfortaffectsyou 2.9 3.1 3.1 3.2Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 2.9 3.1 3.0 3.2Relationshipwithyourspouse/partner 3.0 2.8 3.1 3.1Relationshipwithandabilitytocareforyourchildren 2.7 2.7 3.1 2.8

Nrange= 52-110 81-154 70-149 23-52

PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyHighestLevelofEducation(onlycategorieswithN>10)

Ingeneral,patientsresidingintheWesternUS/MountainareasfeltlessunderstoodthandidthoseintheMidwestorEasternregions,exceptregardingtheimpactsoftheirconditionsontheirabilitytowork.Regionaldifferenceswereparticularlypronouncedforimpactsonrelationships(bothfamilyandcommunity),asopposedtoclinicalaspectsofthediseasesuchassymptoms/painandabilitytoperformbasictasksofdailyliving,possiblyreflectingculturaldifferencesincommunication.

PatientViewsonUnderstandingbyProviders:ByGeographicRegion

West,Southwest Mountain Midwest Northeast Southeast

What’smostimportanttoyouinatreatment 3.3 3.3 3.4 3.6 3.4Thesymptomsthatbotheryouthemost 3.2 3.5 3.5 3.4 3.5Allofthedifferentkindsofsymptoms 3.2 3.2 3.4 3.5 3.5Whatsideeffectsyouexperience 3.2 2.8 3.5 3.4 3.4Typeofpain/discomfort 3.1 3.2 3.2 3.4 3.4Amountofpain/discomfort 3.2 3.2 3.2 3.3 3.4Whatyouworryaboutinatreatment 3.1 3.1 3.4 3.3 3.3Worklifeandabilitytomakealiving 3.1 3.5 3.4 3.0 3.2Howyourothermedicalconditions(besidesthisone)affectyou 2.9 3.6 3.1 3.2 3.3Abilitytoperformbasictasksofliving(hygiene,housework,etc.) 3.0 3.0 3.2 3.2 3.2Abilitytotakepartinactivitieswithfriendsandinthecommunity 3.0 2.6 3.3 2.9 3.2Howthecostaffectsyou 3.1 2.6 3.0 3.1 3.2Howtheinconvenienceordiscomfortaffectsyou 2.8 2.6 3.0 3.2 3.2Mentalhealth/emotionalstate(e.g.Happiness,worry,stress) 3.0 2.8 3.2 3.0 3.1Relationshipwithyourspouse/partner 2.9 2.5 3.2 2.7 3.1Relationshipwithandabilitytocareforyourchildren 2.7 2.2 3.0 2.8 2.9

Nrange= 36-63 5-16 33-62 51-95 100-227

PerceptionsofDoctors’andNurses’UnderstandingofPatientExperiencebyRegion

Patients:ArethereaspectsofhowyourconditionortreatmentaffectsyouthatyoudoNOTsharewithyourhealthcareproviders?

UnderstandingofPatientsbyProviders

UnderstandingofPatientsbyProviders:ReasonsforNotSharing

• Embarrassment/shameintalkingaboute.g.disability,difficultywithpersonalorhomecare/hygiene,sexualorboweldysfunction,etc.

• Concernsregardingconfidentiality,notwantingittobecome“partofrecord”• Fearofe.g.gettingdriver’slicenserevoked,beingpreventedfromworking,beingusheredinto

“psychtrack”ofmedicalcare• Fearofbeingprescribedmedicationsthattheydon’twanttotake• Fearofhavingcurrentlyprescribedmedications“takenaway”• Emotionallydifficulttotalkaboutfears/anxieties,upsetting• Fearofjudgmentregardinge.g.dietaryhabits/weight,sexualhistory/lifestyle,substanceuse,etc.• Assumptionthatifhealthcareprovidersdon’taskaboutthesethings,thentheydon’tcare/not

partofjob;“medicineisaboutscience,notaboutlife”• Fearoftalkingaboutsomethingpersonalandmeaningfulandnotbeinglistenedto;feeling

unimportant,worthless• Perceptionofbeingrushedthroughmedicalvisits,notimetotalk• Previousexperiencewithtryingtotalktohealthcareprovidersaboutthesethingsandgetting

demeaning/uncaringresponsesà frustrationandhurt• Fearoflosingservicesiftheybecomelabeledas“difficult,”“refractory,”“time-consuming,”orat

riskforaddiction

UnderstandingofPatientsbyProviders: DiseaseAspectsNotShared

• Painandpsychologicalimpactsthereof• Disability,inwork,self-care,careofothers(e.g.children,pets)• Emotionalimpactsofdisease,i.e.anxiety,fears

– “Itriedtotellhimandhesaidhewasn’tasocialworker.”• “Non-critical,”“non-medical”aspectsofdisease,i.e.inabilityto“havefun,”toperformparticular

self-careorchild-caretasks,etc.– “Someissuesarenotmedical…Iamhavingtroublebuttoningmyshirt.And,Ican’tbend

overtotieshoesanymore.Ican’treachmyfeettoputonsocks.”• Impactsonsexualityandrelationships• Implicationsoflifestyledecisionsondisease,i.e.diet,sexuallifestyle,useofalternative

therapies,etc.• Anyinformationthatcouldimpactprivileges/permissions,i.e.visualeffectsthatcouldimpact

driver’slicense,injuries/painthatcouldimpactpermissiontoreturntowork,cognitiveissuesthatcouldimpactindependentliving,etc.

• Bowelfunction• Addiction/dependence• Obesity-relatedissues• Financialaspectsofdiseaseand/ortreatment

ConfidenceinInformationProvided

toClinicalTrialParticipants

Mostpatientshadatleastafairlevelofconfidencethattrialparticipantsareinformedfullyandhonestlyabouttheclinicaltrialprocess.Patientsweremostlikelytobeconfidentininformationprovidedaboutrighttowithdraw,procedures,andpossiblebenefits,andweremostskepticalaboutinformationrelatingtotreatmentalternatives,risksandsideeffects,anddoctors’motivations.

Patients’ConfidenceinClinicalTrialParticipantInformation

Righttodropoutofthestudy

Typesofprocedurestobeperformed

Possiblebenefitsofstudytreatment

Overalltimecommitment

Howpersonalinformationwillbekeptprivate

Costsassociatedwithstudyparticipation

Painordiscomforttoexpect

Ifandhowpatientswillreceiveinformationaboutthestudy

Possiblerisksofstudytreatment

Doctor’smotivationsfordoingthestudy

Possiblesideeffectsofstudytreatment

Otherwaysofgettingtreatmentbesidesstudyparticipation

1- Notatallconfident 2 3 4 5- Veryconfident

Mean N4.1 399

3.9 439

3.9 433

3.8 447

3.8 434

3.7 418

3.6 422

3.5 420

3.4 436

3.4 411

3.4 436

3.3 386

Whenpatientsareapproachedaboutclinicaltrialsrunbypharmaceuticalcompanies,howconfidentdoyoufeelthattheyareinformedfullyandhonestlyabouteachofthefollowing?

Typesofprocedures

Righttodropout

PossiblesideeffectsPossiblerisks

Possiblebenefits

Painordiscomfort

Privacyofpersonalinfo

Otherwaystogettreatment

Doctor'smotivations

Communicationofresults

3.0 3.5 4.0 4.5 5.0

Sponsor/CROAQCMembers

BothpatientsandAQCMemberrespondentswerereasonablyconfidentinpatients’receiptofcompleteandhonestinformationabouttherighttowithdrawfromatrial,itsprocedures,anditspossiblebenefits,andbothwereskepticalaboutinformationregardingthecommunicationofresultsanddoctors’motivations.AQCMemberswerequiteconfidentinpatients’receiptofcompleteandhonestinformationaboutpossiblesideeffects,risks,anddiscomforts,butpatientswerelessso.

Patientvs.AQCMemberConfidenceinClinicalTrialInformation

Patients:N=386-447SponsorN=83-94,CRON=63-76Q:AsaSponsor/CROexecutingtrialsonbehalfofSponsors,howconfidentareyouthatpotentialclinicaltrialparticipantsarefullyandhonestlyinformedabouteachofthefollowing?

ConfidenceThatTrialParticipantsareInformedAbout…MeanRatings:1=NotAtAllConfidentto5=VeryConfident

Muchofthepatient-sponsordifferenceinconfidencewasdrivenbypatientswithnoexperienceinclinicaltrials;patientswithclinicaltrialexperiencehadsubstantiallygreaterlevelsofconfidence– muchclosertothelevelsexhibitedbyAQCmembers– thandidthosewithnohistoryofclinicaltrialparticipation(thisslideandnext).

Patients:N=185to204SponsorN=83-94,CRON=63-76Q:AsaSponsor/CROexecutingtrialsonbehalfofSponsors,howconfidentareyouthatpotentialclinicaltrialparticipantsarefullyandhonestlyinformedabouteachofthefollowing?

Typesofprocedures

Righttodropout

Possiblesideeffects

Possiblerisks

Possiblebenefits

Painordiscomfort

Otherwaystoget

treatment

Doctor'smotivations

3.0 3.5 4.0 4.5 5.0

ithClinicalTria

lHistory

PatientswithClinicalTrialHistoryvs.AQCMemberConfidenceinClinicalTrialInformation

37Patients:N=201to243SponsorN=83-94,CRON=63-76Q:AsaSponsor/CROexecutingtrialsonbehalfofSponsors,howconfidentareyouthatpotentialclinicaltrialparticipantsarefullyandhonestlyinformedabouteachofthefollowing?

Typesofprocedures

Righttodropout

PossiblesideeffectsPossiblerisks

Possiblebenefits

Painordiscomfort

Otherwaystogettreatment

Doctor'smotivations

3.0 3.5 4.0 4.5 5.0

tClinicalTria

lHistory

PatientswithoutClinicalTrialHistoryvs.AQCMemberConfidenceinClinicalTrialInformation

Meanratingsonascaleof1(notatallconfident)to5(veryconfident)

Chronicbutstable Degenerative Episodic

Righttodropoutofthestudy 4.1 4.0 3.9

Typesofprocedurestobeperformed 4.0 3.8 3.8

Possiblebenefitsofstudytreatment 3.9 3.9 3.8

Overalltimecommitment 3.9 3.8 3.7

Howpersonalinformationwillbekeptprivate 3.9 3.8 3.7

Costsassociatedwithstudyparticipation 3.8 3.7 3.5

Painordiscomforttoexpect* 3.7 3.4 3.6

Ifandhowpatientswillreceiveinformationaboutthestudy,includingtheirpersonalresults* 3.6 3.4 2.9

Possiblerisksofstudytreatment 3.5 3.4 3.1

Doctor’smotivationsfordoingthestudy 3.6 3.3 3.1

Possiblesideeffectsofstudytreatment* 3.5 3.3 3.1

Otherwaysofgettingtreatmentbesidesstudyparticipation* 3.4 3.0 3.2

Nrange= 228-260 112-130 36-44

Patientswithchronicconditionswereonaveragemoreconfidentthanothersintheinformationprovidedtoclinicaltrialparticipants,andthosewithepisodicconditionsweregenerallyleastconfident.

Patients’ConfidenceinClinicalTrialInformation:ByTypeofCondition

ConfidencethatStudyPatientsareFullyandHonestlyInformedbyTypeofMedicalCondition(onlycategorieswithN>10)

Patientswithmildconditionswereonaveragemoreconfidentthanothersintheinformationprovidedtoclinicaltrialparticipants.

Patients’ConfidenceinClinicalTrialInformation:ByImpactofCondition

Meanratingsonascaleof1(notatallconfident)to5(veryconfident) Severe Moderate Mild Itvaries None

Righttodropoutofthestudy 4.1 4.0 4.3 4.3 3.8

Typesofprocedurestobeperformed 3.9 4.0 4.2 3.8 3.6

Possiblebenefitsofstudytreatment 4.0 3.8 4.2 3.9 4.0

Overalltimecommitment 3.9 3.7 4.1 3.7 3.9

Howpersonalinformationwillbekeptprivate* 3.8 3.6 4.3 3.8 3.7

Costsassociatedwithstudyparticipation* 3.7 3.6 4.2 3.6 3.6

Painordiscomforttoexpect 3.5 3.5 3.9 3.5 3.7

Ifandhowpatientswillreceiveinformationaboutthestudy,includingtheirpersonalresults 3.4 3.4 3.7 3.4 3.6

Possiblerisksofstudytreatment* 3.3 3.3 3.9 3.3 3.6

Doctor’smotivationsfordoingthestudy 3.4 3.3 3.7 3.3 3.8

Possiblesideeffectsofstudytreatment* 3.4 3.2 3.8 3.3 3.7

Otherwaysofgettingtreatmentbesidesstudyparticipation*** 3.0 3.1 3.9 3.5 3.5

Nrange= 113-135 142-156 64-75 42-56 22-29

ConfidencethatStudyPatientsareFullyandHonestlyInformedbyImpactofMedicalCondition

Therewasageneraltrendwherebypatientswhoseetheirphysiciansfrequentlymaybemoreskepticalabouttheinformationprovidedtoclinicaltrialparticipantsthanwerepatientswhoseetheirphysicianslessoften.

Patients’ConfidenceinClinicalTrialInformation:ByFrequencyofCare

5to12timesperyear

2to4times

peryear

Onceperyearorless

Itdepends

Typesofprocedurestobeperformed* 3.8 3.6 4.1 4.0 4.0

Howpersonalinformationwillbekeptprivate 3.5 3.7 3.9 3.7 4.1

Costsassociatedwithstudyparticipation 3.8 3.6 3.9 3.5 3.7

Painordiscomforttoexpect* 3.6 3.2 3.6 3.9 3.7

Ifandhowpatientswillreceiveinformationaboutthestudy,includingtheirpersonalresults 3.2 3.3 3.6 3.4 3.7

Possiblerisksofstudytreatment 3.4 3.1 3.5 3.5 3.7

Possiblesideeffectsofstudytreatment 3.4 3.1 3.5 3.5 3.5

Otherwaysofgettingtreatmentbesidesstudyparticipation 3.1 3.0 3.3 3.5 3.4Nrange= 37-43 70-83 191-224 43-49 37-48

ConfidencethatStudyPatientsareFullyandHonestlyInformedbyFrequencyofCare

Patientswhohadactuallyparticipatedinclinicaltrialsweremoreconfidentinthehonestyandcompletenessofinformationprovidedtotrialparticipantsthanwerepatientswhohadnot,ineveryareaexceptforone:howpatientswouldreceivestudyresults,includingpersonalresults.Evenamongpriortrialparticipants,however,confidencewasnotstronginsomeareas.

Patients’ConfidenceinClinicalTrialInformation:ByHistoryofTrialParticipation

Meanratingsonascaleof1(notatallconfident)to5(veryconfident) Yes No

Righttodropoutofthestudy*** 4.3 3.9

Typesofprocedurestobeperformed**** 4.2 3.8

Possiblebenefitsofstudytreatment 4.0 3.9

Overalltimecommitment** 4.0 3.7

Howpersonalinformationwillbekeptprivate 3.9 3.7

Costsassociatedwithstudyparticipation* 3.9 3.6

Painordiscomforttoexpect 3.7 3.5

Ifandhowpatientswillreceiveinformationaboutthestudy,includingtheirpersonalresults 3.5 3.5

Possiblerisksofstudytreatment** 3.6 3.3

Doctor’smotivationsfordoingthestudy* 3.6 3.3

Possiblesideeffectsofstudytreatment* 3.5 3.3

Otherwaysofgettingtreatmentbesidesstudyparticipation 3.4 3.1

Nrange= 185-204 201-243

ConfidencethatStudyPatientsareFullyandHonestlyInformedbyHistoryofTrialParticipation

Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005;****p=.0001(unadjustedformultipletests)

Ingeneral,patientsbetween31and60yearsofagewerelessconfidentinthehonestyandcompletenessofinformationprovidedtotrialparticipantsthanwereyoungerorolderpatients.

Patients’ConfidenceinClinicalTrialInformation:ByAgeGroup

Meanratingsonascaleof1(notatallconfident)to5(veryconfident) 76+ 61-75 46-60 31-45 18-30

Typesofprocedurestobeperformed 4.2 4.1 3.8 3.7 3.7

Howpersonalinformationwillbekeptprivate 4.0 3.9 3.8 3.6 4.0

Costsassociatedwithstudyparticipation* 4.3 4.0 3.5 3.5 3.9

Painordiscomforttoexpect* 3.8 3.8 3.5 3.2 4.1

Ifandhowpatientswillreceiveinformationaboutthestudy,includingtheirpersonalresults. 3.8 3.6 3.4 3.1 4.1

Possiblerisksofstudytreatment* 3.8 3.6 3.3 3.1 4.0

Possiblesideeffectsofstudytreatment* 3.7 3.6 3.3 3.2 3.6

Otherwaysofgettingtreatmentbesidesstudyparticipation 3.7 3.4 3.3 2.8 2.9

Nrange= 13-19 156-180 150-171 52-65 9-10

ConfidencethatStudyPatientsareFullyandHonestlyInformedbyAge

Particularlyfortheaspectsofclinicaltrialinformationaboutwhichpatientsoverallwerelessconfident(towardthebottomofthetable),therewasgenerallyaninverserelationshipbetweeneducationalattainmentandconfidenceintheinformationprovided.

Patients’ConfidenceinClinicalTrialInformation:ByEducationalAttainment

Advanceddegree

Somecollege

Completedhighschool

Righttodropoutofthestudy 4.2 3.9 4.0 4.4

Typesofprocedurestobeperformed 4.1 3.9 3.9 4.0

Possiblebenefitsofstudytreatment 3.9 3.9 4.0 4.1

Overalltimecommitment 3.8 3.8 3.8 4.2

Howpersonalinformationwillbekeptprivate 4.0 3.8 3.7 4.1

Costsassociatedwithstudyparticipation 3.8 3.7 3.7 4.0

Painordiscomforttoexpect 3.6 3.5 3.6 3.7

Ifandhowpatientswillreceiveinformationaboutthestudy,includingtheirpersonalresults* 3.4 3.4 3.4 4.2

Possiblerisksofstudytreatment 3.4 3.3 3.5 3.5

Doctor’smotivationsfordoingthestudy* 3.2 3.3 3.5 4.0

Possiblesideeffectsofstudytreatment 3.3 3.4 3.4 3.6

Otherwaysofgettingtreatmentbesidesstudyparticipation 3.2 3.1 3.3 3.6Nrange= 93-105 126-147 115-139 42-48

ConfidencethatStudyPatientsareFullyandHonestlyInformedbyHighestLevelofEducation(onlycategorieswithN>10)

ConfidenceinQualityofClinicalResearchProcess

Studyteamscollectpatientstudydatainanhonestandunbiasedway.

Studyteamsperformthestudiesexactlythewaytheyaresupposedto.

Studyteamscollectpatientdatawithenoughattentiontodetailto“getitright.”

Studyteamscarefullymonitorthewell-beingofstudypatients.

Studyteamscareaboutstudypatientsaspeople.

Patientswhotakepartinstudiesfollowinstructionscarefully,includingtakingthedrugexactlyastheyaresupposedto.

Studiesaredesignedtolookatthepossiblebenefitsofdrugsinanhonest,unbiasedway.

Studiesaredesignedtolookatthepossiblerisksofdrugsinanhonest,unbiasedway.

Pharmaceuticalcompaniesreportonstudydatainanhonestandunbiasedway.

Pharmaceuticalcompaniescarefullymonitorthewell-beingofstudypatients.

Pharmaceuticalcompaniescareaboutstudypatientsaspeople.

1- Notatallconfident 2 3 4 5- Veryconfident

Mean N

4.0 442

3.9 434

3.9 440

3.8 442

3.7 430

3.6 430

3.5 454

3.5 456

3.3 415

3.3 416

3.1 414

Mostpatientshadatleastafairlevelofconfidenceinthecompliance,caring,andethicsofthesitestudyteamsandpatientsinvolvedinclinicaltrials.However,manywereskepticalaboutthehonestyofpharmaceuticalcompaniesandabouttheextenttowhichtheycaredaboutstudypatients.

Patients’ConfidenceinClinicalTrialComplianceandEthics

Whenitcomestoclinicaltrialsrunbypharmaceuticalcompanies,whatisyourlevelofconfidenceineachofthefollowing?

3.0 3.5 4.0 4.5 5.0

Studiesaredesignedtoanswerquestionsaboutbenefits/risksinhonest/unbiasedway.

Pharmacompaniescarefullymonitorthewellbeingofstudypatients.

Pharmacompaniesreportonstudydatainanhonest/unbiasedway.

Pharmacompaniescareaboutstudypatientsaspeople.

SponsorN=95-99,CRON=75-83;PatientsN=414-456

Patientstakingpartinclinicalstudiesfollowinstructionscarefully.

Onaverage,bothpatientsandAQCMemberrespondentswereslightlyskepticalaboutthecomplianceofpatientstakingpartinclinicalstudies.However,patientsweremuchmoreskepticalaboutthehonestyandcaringofpharmaceuticalcompaniesthanwereAQCMembers.

Patientvs.AQCMemberConfidenceinSponsors’andPatients’ClinicalTrialComplianceandEthics

Levelofconfidencethat…MeanRatings:1=NotAtAllConfidentto5=VeryConfident

3.0 3.5 4.0 4.5 5.0

ithClinicalTria

lHistory

Again,muchofthepatient-sponsordifferenceinconfidencewasdrivenbypatientswithnoexperienceinclinicaltrials;patientswithclinicaltrialexperiencehadsubstantiallygreaterlevelsofconfidence– muchclosertothelevelsexhibitedbyAQCmembers– thandidthosewithnohistoryofclinicaltrialparticipation(thisslideandnext).

Patientvs.AQCMemberConfidenceinSponsors’andPatients’ClinicalTrialComplianceandEthics

3.0 3.5 4.0 4.5 5.0

tClinicalTria

lHistory

PatientswithNoClinicalTrialHistoryvs.AQCMemberConfidenceinSponsors’andPatients’ClinicalTrialComplianceandEthics

Whenaskedhowwellpatient-centricthinkingisincorporatedintothedesignandexecutionofclinicaltrials,bothSponsorsandCROsratethemselvessimilarly,moreorlessintheneutralrange.However,bothgroupsratetheirpartnerslowerandtowardsamoreneutralpositionthantheyseethemselves.

AQCMembers:PerceptionsofPatient-CentricThinking

PerceptionsofPatientCentricityinTrialDesign&ExecutionMeanRatings:1=NotWellAtAllto5=VeryWell

Sponsorsyouworkwith

Yourcompany

YourClinicalServiceProviders

Yourcompany

SponsorN=88-95,CRON=76-81Q:PleaserateyourcompanyandyourClinicalServiceProviders/Sponsorsyouhaveworkedwithinthepastyearonhowwellpatient-centricthinkingisincorporatedintothedesignandexecutionofclinicaltrials.

Sponsor

Meanratingsonascaleof1(notatallconfident)to5(veryconfident) Chronic Degenerative Episodic

Studyteamscollectpatientstudydatainanhonestandunbiasedway. 4.0 3.9 3.9Studyteamsperformthestudiesexactlythewaytheyaresupposedto. 4.0 3.8 3.8Studyteamscollectpatientdatawithenoughattentiontodetailto“getitright.” 3.9 3.8 3.8

Studyteamscarefullymonitorthewell-beingofstudypatients. 3.9 3.7 3.9Studyteamscareaboutstudypatientsaspeople. 3.8 3.6 3.6Patientswhotakepartinstudiesfollowinstructionscarefully,includingtakingthedrugexactlyastheyaresupposedto. 3.6 3.5 3.6

Studiesaredesignedtolookatthepossiblebenefitsofdrugsinanhonest,unbiasedway. 3.6 3.4 3.5

Studiesaredesignedtolookatthepossiblerisksofdrugsinanhonest,unbiasedway.** 3.6 3.3 3.3

Pharmaceuticalcompaniesreportonstudydatainanhonestandunbiasedway. 3.4 3.1 3.4

Pharmaceuticalcompaniescarefullymonitorthewell-beingofstudypatients. 3.4 3.1 3.6

Pharmaceuticalcompaniescareaboutstudypatientsaspeople. 3.2 2.8 3.0Nrange= 232-263 123-141 38-41

Patientswithchronicconditionswereonaveragemoreconfidentthanothersinthecompliance,ethics,andcaringofthoseexecutingclinicaltrials,andthosewithdegenerativeconditionsweregenerallyleastconfident.

Patients’ConfidenceinTrialCompliance/Ethics:ByTypeofCondition

ConfidenceinClinicalTrialComplianceandEthicsbyTypeofMedicalCondition(onlycategorieswithN>10)

Onaverage,patientswithmilddiseaseweremoreconfidentthanothersinthecompliance,ethics,andcaringofthoseexecutingclinicaltrials,andthosewithmoderateorvariableseverityweregenerallyleastconfident.

Patients’ConfidenceinTrialCompliance/Ethics:ByImpactofCondition

Meanratingsonascaleof1(notatallconfident)to5(veryconfident) Severe Moderate Mild Itvaries None

Studyteamscollectpatientstudydatainanhonestandunbiasedway. 4.0 3.9 4.2 3.9 4.0

Studyteamsperformthestudiesexactlythewaytheyaresupposedto. 4.0 3.8 4.2 3.9 4.0

Studyteamscollectpatientdatawithenoughattentiontodetailto“getitright.” 3.9 3.8 4.1 3.8 3.9

Studyteamscarefullymonitorthewell-beingofstudypatients. 3.8 3.7 4.1 3.8 4.0Studyteamscareaboutstudypatientsaspeople. 3.7 3.6 4.1 3.6 3.9Patientswhotakepartinstudiesfollowinstructionscarefully,includingtakingthedrugexactlyastheyaresupposedto. 3.6 3.5 3.6 3.6 3.8

Studiesaredesignedtolookatthepossiblebenefitsofdrugsinanhonest,unbiasedway. 3.5 3.4 3.9 3.4 3.6

Studiesaredesignedtolookatthepossiblerisksofdrugsinanhonest,unbiasedway. 3.5 3.4 3.8 3.3 3.8

Pharmaceuticalcompaniesreportonstudydatainanhonestandunbiasedway. 3.3 3.2 3.8 3.2 3.4

Pharmaceuticalcompaniescarefullymonitorthewell-beingofstudypatients.* 3.2 3.2 3.8 3.2 3.5

Pharmaceuticalcompaniescareaboutstudypatientsaspeople. 3.0 2.9 3.5 3.0 3.2Nrange= 124-139 144-159 60-72 53-59 25-29

ConfidenceinClinicalTrialComplianceandEthicsbyImpactofMedicalCondition

Onaverage,patientswhosawtheirtreatingphysiciansfrequentlyweremoreskepticalaboutthecompliance,ethics,andcaringofthoseexecutingclinicaltrialsthanwerethosewhosawtheirproviderslessfrequently.

Patients’ConfidenceinTrialCompliance/Ethics:ByFrequencyofCare

5to12times

peryear

2to4times

peryear

Onceperyearorless

Itdepends

Studyteamscollectpatientstudydatainanhonestandunbiasedway. 3.9 3.8 4.0 4.1 4.0

Studyteamsperformthestudiesexactlythewaytheyaresupposedto. 3.9 3.7 4.0 4.1 4.0

Studiesaredesignedtolookatthepossiblerisksofdrugsinanhonest,unbiasedway. 3.5 3.4 3.5 3.6 3.5

Pharmaceuticalcompaniescarefullymonitorthewell-beingofstudypatients. 3.1 3.2 3.4 3.5 3.3

ConfidenceinClinicalTrialComplianceandEthicsbyFrequencyofCare

Onaverage,patientswhohadparticipatedinclinicaltrialsweremoreconfidentinthecompliance,ethics,andcaringofthoseexecutingclinicaltrialsthanwerethosewhohadnot.

Patients’ConfidenceinTrialCompliance/Ethics:ByHistoryofTrialParticipation

Meanratingsonascaleof1(notatallconfident)to5(veryconfident) Yes No

Studyteamscollectpatientstudydatainanhonestandunbiasedway.*** 4.2 3.8

Studyteamsperformthestudiesexactlythewaytheyaresupposedto.* 4.1 3.8

Studyteamscollectpatientdatawithenoughattentiontodetailto“getitright.”**** 4.1 3.7

Studyteamscarefullymonitorthewell-beingofstudypatients.*** 4.1 3.7

Studyteamscareaboutstudypatientsaspeople.*** 4.0 3.5

Patientswhotakepartinstudiesfollowinstructionscarefully,includingtakingthedrugexactlyastheyaresupposedto. 3.6 3.5

Studiesaredesignedtolookatthepossiblebenefitsofdrugsinanhonest,unbiasedway.*** 3.8 3.4

Studiesaredesignedtolookatthepossiblerisksofdrugsinanhonest,unbiasedway.** 3.7 3.4

Pharmaceuticalcompaniesreportonstudydatainanhonestandunbiasedway.** 3.5 3.2

Pharmaceuticalcompaniescarefullymonitorthewell-beingofstudypatients. 3.5 3.2

Pharmaceuticalcompaniescareaboutstudypatientsaspeople. 3.2 3.0

Nrange= 178-201 230-258

ConfidenceinClinicalTrialComplianceandEthicsbyHistoryofTrialParticipation

Note:Highestmeanperrowhighlightedinyellow,lowestinred.*p<.05;**p<.01;***p<.005;****p<.0001(unadjustedformultipletests)

Ingeneral,therewasaninverserelationshipbetweenlevelofeducationalattainmentandconfidenceinthecompliance,ethics,andcaringofthoseexecutingclinicaltrials.

Patients’ConfidenceinTrialCompliance/Ethics:ByEducationalAttainment

Advanceddegree

Somecollege

Completedhighschool

Studyteamscollectpatientstudydatainanhonestandunbiasedway.* 3.8 4.0 4.0 4.3Studyteamsperformthestudiesexactlythewaytheyaresupposedto.** 3.7 3.9 3.9 4.3Studyteamscollectpatientdatawithenoughattentiontodetailto“getitright.”* 3.7 3.8 3.9 4.3

Studyteamscarefullymonitorthewell-beingofstudypatients. 3.7 3.9 3.9 4.1Studyteamscareaboutstudypatientsaspeople. 3.4 3.8 3.8 4.0Patientswhotakepartinstudiesfollowinstructionscarefully,includingtakingthedrugexactlyastheyaresupposedto.* 3.3 3.5 3.7 3.7

Studiesaredesignedtolookatthepossiblebenefitsofdrugsinanhonest,unbiasedway. 3.3 3.6 3.6 3.8

Studiesaredesignedtolookatthepossiblerisksofdrugsinanhonest,unbiasedway. 3.3 3.6 3.4 3.8

Pharmaceuticalcompaniesreportonstudydatainanhonestandunbiasedway.** 2.9 3.4 3.4 3.7

Pharmaceuticalcompaniescarefullymonitorthewell-beingofstudypatients.* 3.0 3.4 3.3 3.7

Pharmaceuticalcompaniescareaboutstudypatientsaspeople.** 2.7 3.1 3.1 3.5Nrange= 100-109 129-144 131-149 40-48

ConfidenceinClinicalTrialComplianceandEthicsbyHighestLevelofEducation(categorieswithN>10only)

Ingeneral,patientsbetween31and60yearsofagewerelessconfidentinthecompliance,ethics,andcaringofthoseinvolvedinclinicaltrialexecutionthanwereyoungerorolderpatients.Thoseinthe76+agegrouphadthehighestlevelofconfidence.

Patients’ConfidenceinTrialCompliance/Ethics:ByAgeGroup

Meanratingsonascaleof1(notatallconfident)to5(veryconfident) 76+ 61-75 46-60 31-45 18-30

Studyteamscollectpatientstudydatainanhonestandunbiasedway.* 4.5 4.1 3.9 3.7 3.9

Studyteamsperformthestudiesexactlythewaytheyaresupposedto.** 4.6 4.1 3.8 3.7 4.0

Studiesaredesignedtolookatthepossiblerisksofdrugsinanhonest,unbiasedway.* 4.2 3.6 3.4 3.3 3.6

Pharmaceuticalcompaniescarefullymonitorthewell-beingofstudypatients. 3.8 3.4 3.3 3.2 3.2

ConfidenceinClinicalTrialComplianceandEthicsbyAge

Onaverage,patientswhowereresponsibleforprovidingdirectcareorfinancialsupportoffamilymembersweremoreskepticalaboutthecompliance,ethics,andcaringofthoseexecutingclinicaltrialsthanwerethosewhowerenot.

Patients’ConfidenceinTrialCompliance/Ethics:ByFamilyResponsibility

Yes (providescareorfinancial supporttofamilymembers)

Studyteamscollectpatientstudydatainanhonestandunbiasedway.* 3.8 4.1

Studyteamsperformthestudiesexactlythewaytheyaresupposedto.* 3.8 4.0

Studyteamscollectpatientdatawithenoughattentiontodetailto“getitright.”* 3.7 4.0

Studyteamscarefullymonitorthewell-beingofstudypatients. 3.7 3.9

Studyteamscareaboutstudypatientsaspeople. 3.7 3.7

Patientswhotakepartinstudiesfollowinstructionscarefully,includingtakingthedrugexactlyastheyaresupposedto. 3.4 3.7

Studiesaredesignedtolookatthepossiblebenefitsofdrugsinanhonest,unbiasedway.* 3.4 3.6

Studiesaredesignedtolookatthepossiblerisksofdrugsinanhonest,unbiasedway.* 3.3 3.6

Pharmaceuticalcompaniesreportonstudydatainanhonestandunbiasedway.* 3.2 3.4

Pharmaceuticalcompaniescarefullymonitorthewell-beingofstudypatients. 3.2 3.4

Pharmaceuticalcompaniescareaboutstudypatientsaspeople. 2.9 3.1Nrange= 165-186 246-270

ConfidenceinClinicalTrialComplianceandEthicsbyFamilyResponsibility

ThemesinOpen-EndedCommentsPatientViewsonActionsthatInfluenceConfidence

• Interactionwithpatientsforfeedbackaboutstudydesignandoperations

– “Theydon’tinteractwithparticipantstogetfeedbackonwhatwasgoodorbadaboutthestudy.”

– “Evidenceofincludingpatientparticipationintrials’creation,monitoring,andmeasurementofassessmentusingviabletools.”

• Faircompensation,andcaring,respectful,andequitabletreatmentasparticipantsintheresearchprocess:

– “Whiletheprotocolispatient-centered,theback-upandbedsidemannerdonotalwayswork.”

– “Careaboutpatientsaspeople?Ha!Thenwhyarewecalled‘subjects’??Andwhyaren’twecompensatedmuchbetterandsoonerinthestudy?Thesponsorsmakeobsceneamountsofmoneyandskipwhenitcomestoallaspectsofpatientinteraction.Whyarethevisitsalwayssoinconvenient?Whyaren’tthereeveningandweekendhours?Whyaren’tstafftrainedininterpersonalcommunication,especiallythechiefinvestigatingphysician?”

– “Itboilsdowntotheirtakingtimewithme.Beingtransparentaboutwhattheyaredoingstep-by-stepandexplainingwhatisgoingon.”

ThemesinOpen-EndedComments,continuedPatientViewsonActionsthatInfluenceConfidence

• Averylargenumberofcommentshadtodowithbusinessconcerns.Whilepatientsweremostlikelytocitetheprofitmotivesofpharmaceuticalcompaniesormedicalpractitionersasahugesourceofdistrust,somealsoderivedconfidencefromthisfact,reflectingthat“findingthetruth”madegoodbusinesssenseandthatanyunethicalconductwouldreturnpoorlyinthelongtermbothintermsofproductinvestmentsandintermsofliabilities.

– “Themedicalandpharmaceuticalindustries’mainpriorityismoney!Whenmoneyisthemostimportantthing,peoplearenottoldcompleteinformation.It’sabasicconflictofinterest!”

– “Re.doctors’motivations,Idon’trememberthisparticularaspectofeithertrialweparticipatedin,orthevariousothertrialsIconsidered,everhavingbeenmentioned.”

– “Ithinkmostofthemunderstandthatforlong-termsuccesstheyneedtodevelopdrugsthataregoodforbothpatientsandtheircompany,soincentivesarealignedinsomerespect.”

– “I’vebeentoconferenceswherethemainspeakeristryingtoconvincepeopletoparticipateinclinicaltrials.Noneofthesideeffectswereaddressed.Itwastrulya‘salespitch.’”

ThemesinOpen-EndedComments,continuedPatientViewsonActionsthatInfluenceConfidence

• Manypatientsreportthattheirconfidenceintheteamsperformingclinicalstudiescomeslargelyfromtheirfaiththatthesepartiesaregovernedbyregulationsandmonitoringbodies(includingethicscommittees),andfearfuloflawsuits.

• Manyalsoreportconfidencesimplyintheprofessionalismandgoodintentionsofresearchers,practitioners,andinstitutionsoperatinginthemedicalfield.

• Perceivedtransparencyintheareasofstudyprocedures,studyresults,drugrisks,IRBinteractions,doctormotivations,etc.wasregardedasasourceofconfidencebypatientswhohadexperiencedsuchtransparency.Conversely,alackoftransparencyintheserespects,particularlyinthedisseminationofresults,wascitedasasourceofdistrust.

– “Theteam…madesureIunderstoodeverythingaboutthestudyandwasquicktorespondwhenanyquestioncameup.”

– “IaskedforfeedbackafterthestudyIdidparticipateinandneverreceivedit.Iknowofno-onewhotrustspharmaceuticalcompanies.”“IfeelasthoughIhavebeenforgotten.”

• Mediareportsregardingcorruptionanddrugrecalls,andlawyer’sadvertisementsregardingclassactionsuits,werecitedassourcesofdistrustintheindustry.

PerspectivesonClinicalTrialParticipation

Nearlyhalfofthepatientsurveyedhadparticipatedinaclinicaltrial.Themostcommonreasonfordoingsowastheopportunitytocontributetoscience,followedbytheopportunitytolearnmoreabouttheirconditionsandbypaymentforparticipation.Themajorityofclinicaltrialparticipantsreportedfeelingmoreeducatedandinvolvedintheiroverallhealthasaresult.

PatientSurvey:ClinicalTrialParticipationRateandReasons

Whydidyoudecidetoparticipateintheclinicaltrial?

Opportunitytocontributetoscience

Opportunitytolearnmoreaboutmycondition

Iwaspaidtoparticipate

Accesstofreehealthcare

Morecontactwithdoctors/nursesthanIwouldotherwiseget

AccesstobetterdoctorsandhospitalsthanIwouldotherwisebeabletouse

Influencedbymyfamily/friends65%14%

21% Yes

Notsure

45%55%

Haveyoueverparticipatedinaclinicaltrial?

Ifyes,didyoufeelmoreeducatedandinvolvedinyouroverallhealthasaresult?

Morecontactwithdoctors/nursesthanIwould…

AccesstobetterdoctorsandhospitalsthanIwould…

Influencedbymyfamily/friends

Whydidyoudecidetoparticipateintheclinicaltrial?byTypeofMedicalCondition

AccesstobetterdoctorsandhospitalsthanIwouldotherwisebe

abletouse

Thereweresomedifferencesacrosspatientswithdifferenttypesofmedicalconditionsinthereasonsfordecidingtoparticipateinclinicaltrials.Althoughthetopfourreasonswereallthesame,andinthesameorder,patientswithchronicanddegenerativeconditionsgenerallyendorsedmorereasonsfortrialparticipationthandidthosewithepisodicconditions,particularlyincludingadesireformorecontactwithdoctors/nurses,andaccesstobetterhospitalsanddoctors,thantheywouldotherwiseget.

PatientSubsets:TypeofMedicalCondition

Chronic

Degenerative

Episodic

PatientSubsets:ImpactofMedicalCondition

Whydidyoudecidetoparticipateintheclinicaltrial?byImpactofMedicalCondition

abletouse

Severe

Moderate

Itvaries

Therewerealsodifferencesacrosspatientswithdifferentseveritiesofmedicalconditions.Althoughagainthetopthreereasonsfortrialparticipationwereallthesame,patientswithmilddiseaseweremorelikelytobeinfluencedbyaccesstofreehealthcarethanwerethosewithmoreseriousconditions,andthosewithnoimpactweremorelikelytobeinfluencedbypayment(seenextslide).

PatientSubsets:ImpactofMedicalCondition(continued)

Whydidyoudecidetoparticipateintheclinicaltrial?byImpactofMedicalCondition

abletouse

Severe

Moderate

Itvaries

PatientSubsets:EmploymentStatus

Whydidyoudecidetoparticipateintheclinicaltrial?byCurrentEmployment

abletouse

Fulltime

Parttime

Retired

Notsurprisingly,employmentstatusalsoinfluencedpatients’decision-makingcriteria(thisslideandnext).Againthetopthreereasonsfortrialparticipationwereallthesame,however,fullyemployedpatientswerelesslikelythanotherstobeinfluencedbypaymentorbytheopportunitytolearnabouttheirconditions,andmorelikelytobeinfluencedbythechancetocontributetoscience.

PatientSubsets:EmploymentStatus(continued)

Whydidyoudecidetoparticipateintheclinicaltrial?byCurrentEmployment

abletouse

Fulltime

Parttime

Retired

PatientSubsets:AgeGroup

Whydidyoudecidetoparticipateintheclinicaltrial?byAge(onlycategorieswithN>10)

abletouse

Agegroupappearedtohaveasubstantialimpactonpatients’decision-makingcriteria(thisslideandnext),thoughtheNsinsomegroupsweresmall.Forolderpatients(76+),theadditionalexpectedcontactwithdoctorsandnurseswasakeyreasonforparticipation,whereasforyoungerpatients(31-60),accesstobetterdoctorsandhospitalswasmorelikelytobeakeyfactor.

PatientSubsets:AgeGroup(continued)

Whydidyoudecidetoparticipateintheclinicaltrial?byAge

abletouse

PatientSubsets:Sex

Whydidyoudecidetoparticipateintheclinicaltrial?bySex

abletouse

Female

Femalesingeneralendorsedmorereasonsforparticipatinginclinicaltrialsthandidmales,thoughtheoverallpatternoftopreasonswasthesame.

ThemajorityofbothAQCMembersandPatientsstatedthattheywouldrecommendclinicalresearchparticipationtoalovedoneorfriend,butmanyineachgroupstatedthattheyweren’tsure.Amongthosenotsure,severityofdiseaseandavailabilityofotheroptionswerevolunteeredascommentsforambivalence.

WillingnesstoRecommendClinicalResearchParticipation

2%16% Yes

Notsure 67%4%

29% Yes

Notsure

SponsorN=102,CRON=85;PatientsN=422Q:Basedonyourexperience,wouldyourecommendclinicalresearchparticipationtoalovedoneorfriend?

Sponsor/CROAQCMembers Patients

Amongthosewhoresponded“Yes”,responsescarriedthemesofconsiderationofrisksandbenefits,oftheinstitutionsatwhichthestudiesarebeingperformed,andofawishto“dogood”forsociety.“No”responsesgenerallyreflecteddistrustoftheindustry.

Patients:ClinicalTrialParticipation

• “Itwoulddependonthedrugsinvolved,lengthoftime,andseverityofmyfriend’scondition.”• “Ifit’sadouble-blindtrialwithplacebo,thenI’mhesitanttoparticipateorrecommendparticipationbecauseImightwindupgoingwithoutmedicationforaconditionthatneedsmedicating.”• “Ionlydoitforthemoney.”• “Ifmorepeopledon’tparticipateinclinicalresearch,thentheymightaswellconsiderthemselvesasbeingexperimentedonwithmarketeddrugs.”• “Don’tgoinblindanddumb.Askplentyofquestions.Itwouldhelpifpatientsgotacrashcourseinwhatthestudywasaboutandwhattoexpectintheformofapamphlet.Neverseenthatbefore.Everythingisvague,politicallycorrect,andgeneral…Wealsoneedtobecompensatedbetter,likewematterasmuchastherestofthestudyteam.”• “Scienceneedsallthehelpitcanget.”• “Iwanttohelppeople.EvenifIendupintheplacebogroup.”

PatientsN=422Q:Basedonyourexperience,wouldyourecommendclinicalresearchparticipationtoalovedoneorfriend?

Amongthosewhoresponded“Yes”,responsescarriedacommonthemeofdirecircumstance(lifethreateningdisease/absenceofotheroptions)andconsiderationofrisksandbenefits.“No”responsesdidnotoffercomments.

AQCMembers:ClinicalTrialParticipation

• “IwouldparticipateinaclinicaltrialmyselfifitwasfortreatmentforaconditionIwassufferingfromandIbelievedthatthistrialcouldbenefitmeandsociety.”• “Ofcourse,Iwouldsaythatnotalltrialsarecreatedequalandthelovedoneorfriendshouldevaluatetheconsentdocumentcarefully,asklotsofquestions,andaskforadditionalsourcesofinformation.”• “Iftherearelimitedtreatmentswhichareapprovedandavailabletoafamilymember,Iwoulddefinitelyrecommendaclinicaltrialapproach.”• “PhaseIhealthyvolunteerswithNME- NO!Ifloved-one/friendhadalife-threateningdiseaseandtreatmentoptionswerelimitedthenIwouldrecommendtheyfindoutaboutappropriateclinicaltrial.”• “Oncology,forsure.Lessconfidentaboutotherindications.”• “Thereneedstobemoreinformationforpatientsontrials,andmoretrialsincriticalareas(e.g.autism).”• “Iwouldforsurerecommendparticipationinatrial,whenthereisenoughinformationgivenontherisk-benefitratio,sideeffectsandotherpotentialtreatmentsoutsideofatrial.”• “IwouldrecommendEXPLORINGclinicaltrialresearchparticipationbasedontheethicsappliedbythecompaniesthatgenerallysponsorandexecutethem,butclinicalresearchcomeswithinherentrisk;thepotentialrisksneedtobewellunderstoodbeforecommitting.”

SponsorN=102,CRON=85Q:Basedonyourexperience,wouldyourecommendclinicalresearchparticipationtoalovedoneorfriend?

AQCMemberSurvey:Perceptionsof

ClinicalResearchQuality

PerceptionsofQualityOverTimeThoughtherecontinuestobeadifferencebetweenCROsatisfactionwithqualitydeliveredandsatisfactionwithqualityreceivedamongSponsors,anupwardtrendinSponsorratingsisdrivingamovetowardsconvergenceatanoverallhigherlevelofsatisfactionwithqualitydeliveredascomparedto2012.

SponsorN=101,CRON=85SponsorQ:ThinkingaboutyourexperienceswithClinicalServiceProvidersyouworkedwithin2015,howsatisfiedareyouwith…thequalitydeliveredbyyourClinicalServiceProviders?ProviderQ:Thinkingaboutyourexperiencesin2015,howsatisfiedareyouwith…thequalitythatyourcompanydeliveredtoSponsors?

Sponsor CRO

Mean: 3.6 4.2

Verysatisfied

Verydissatisfied 3.3 3.2 3.1

3.43.6

3.84.0 4.1 4.2 4.2

2012 2013 2014 2015 2016

Sponsor CRO

MeanRatingTrend

SatisfactiononKeyRelationshipMetricsSponsorsandCROsarecloselyalignedintheirsatisfactionwithrelationships,howevertheydifferintheirperceptionofsatisfactionwithrespecttoquality,overallworkdeliveredandvalueformoney.

Sponsor CROYourrelationships withtheCSPswithwhichyouwork

Yourrelationships withtheSponsorswithwhichyouwork

Thequality deliveredbyyourCSPs

Thequality thatyourcompanyhasdeliveredtoSponsors

TheoverallworkthathasbeendoneforyoubyyourCSPs

TheoverallworkthatyourcompanydeliveredforSponsors

Thevalue thatyouhavereceivedforthemoneyspentonyourCSPs

Thevalue thatyourcompanyhasdeliveredforthemoneyreceivedfromSponsors

SponsorN=92-101,CRON=82-85SponsorQ:ThinkingaboutyourexperienceswithClinicalServiceProvidersyouworkedwithin2015,howsatisfiedareyouwith…ProviderQ:Thinkingaboutyourexperiencesin2015,howsatisfiedareyouwith…

TheAvocaQualityConsortiumbringstogetherquality,outsourcingandoperationalprofessionalsfrommemberpharma,biotech,nicheclinicalserviceproviders,andCROorganizationstoaccelerateandstreamlineclinicaltrialexecutionandimprovequalitythroughindustrycollaboration.

Thankyou

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