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

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UsageGuidelines

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

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Introduction:2016AQCSurveyPrograms

Introduction

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

• TheoverallobjectivesoftheAQCPatientSurveyweretogainanunderstandingof:

– theextenttowhichpatientsperceivethattheirmedicalcareprovidersunderstandvariousaspectsofthepatientexperience,

– patientperceptionsof“quality”andvalueinclinicalresearch,aswellasactionsbyresearchersthatmightpositivelyandnegativelyimpacttheseperceptions,and

– factorsthatdrivepatients’desirestoparticipateandcontinueinclinicaltrials.

• Theobjectiveofthe2016AQCMemberSurveywastoexaminequalitytopicsinamannerthatparalleledthePatientSurvey,aswellastocontinuetofollowMemberperceptionsofkeyqualityindicatorsovertime.

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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.

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Methodology:AQCMemberSurvey

Introduction

• TheAQCMembersurveywasaweb-basedsurveyofSponsorandCROAvocaQualityConsortiumMembers.

• Atotalof188respondentscompletedthesurvey,amongkeyaudiencesasfollows:

– 103fromSponsororganizations

– 85fromCROs

• AllsurveyswerecompletedbetweenMarchandJuneof2016.

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CharacteristicsofthePatientSample

7

54%

21%

19%6% Married/domesticpartner

Divorced/separated

Single

Widow/widower

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

CharacteristicsofPatientSample:Demographics

13%3%

13%

21%

50%

West,Southwest

Mountain

Midwest

Northeast

Southeast

MaritalStatus

N=491

N=494

73%

27%Female

Male

Sex

3%15%

38%

39%

5% 18to30

31to45

46to60

61to75

76+

N=492

AgeRegionwithintheUS

N=497

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CharacteristicsofPatientSample:MedicalConditions

9%

29%59%

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

7%12%

17%

34%

29%

None

Itvariesalotovertime

Mild

Moderate

Severe

Don’tknow

Howoftendoyouseethedoctorresponsiblefortreatingyourcondition?

12%

48%20%

9%10% Onceperyearorless

2to4timesperyear

5to12timesperyear

Morethan12timesperyear

Itdepends

Can'trecall

Themajorityofrespondentsreportedchronicordegenerativemedicalconditions,andmostexperiencedmoderateorsevereimpactsontheirlives.Abouttwo-thirdssawtheirtreatingdoctorsbetween2and12timesperyear.

ImpactofMedicalCondition

N=580

TypeofMedicalCondition

N=581

N=582

9

42%

58%

Yes

No

24%

13%

31%

32%Fulltime

Parttime

Retired

No

23%

33%

32%

11% Advanceddegree

Completedcollegedegree

Somecollege

Completedhighschool

Somehighschool

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

CharacteristicsofPatientSample:EducationandEmployment

Doyouhavefamilymembersforwhomyouprovidecareorfinancialsupport?

HighestLevelofEducation

N=497

N=578

Areyoucurrentlyemployed?

N=581

10

CharacteristicsoftheAQCMemberSample

11

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

ICON

INCResearch

PPD

PRA

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Sponsorrespondentsrepresentedcompaniesofvaryingsize,whileCROrespondentswerecomprisedofLargeandMid-sizedCROs.AmajorityofrespondentsfrombothSponsorsandCROsrepresentedcompaniesheadquarteredintheUnitedStates,withtheremainderprimarilyinWesternEurope.

CharacteristicsofAQCMemberSample:CompanySize&Location

78%

19%1%2% UnitedStates

WesternEurope

Japan

Other

Sponsors CROs

41%

15%17%

26%1%

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

71%

27%2% UnitedStates

WesternEurope

Japan

Other

67%

33%

LargeCRO($1+Brevenue)

Mid-sizedCRO($100-$999Mrevenue)

Small/SpecialtyCRO(<$100Mrevenue)

Other

N=103

N=103

N=84

N=84

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ThesamplewaslargelycomposedofrespondentsrepresentingtheClinicalDevelopment/Operationsfunctionoftheirorganizations,followedbyQualityAssurance/QualityControl.

CharacteristicsofAQCMemberSample:RespondentRoles

Sponsors CROs

54%

16%

3%

18%7%

ClinicalDevelopment/Operations

Procurement/Outsourcing/VendorManagementRegulatoryAffairs

Medical/Scientific

ExecutiveManagement

QualityAssurance/QualityControl

Other

52%

12%4%7%

19%6%

ClinicalDevelopment/Operations

BusinessDevelopment

AllianceManagement/Partnerships

Medical/Scientific/Regulatory

ExecutiveManagement

QualityAssurance/QualityControl

Other

N=102 N=84

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ApproximatelyhalfofrespondentsfromSponsororganizationsindicatedthattheyutilizeamixoffull-serviceandfunctionaloutsourcingforclinicaldevelopment,followedbyprimarilyusingafunctionalproviderandprimarilyutilizingafull-serviceapproach.

CharacteristicsofAQCMemberSample:OutsourcingModels

19%

23%58%

Primarily(>80%)full-serviceoutsourcing

Primarily(>80%)functionaloutsourcing

Mixoffull-serviceandfunctionaloutsourcing

Sponsors’OutsourcingModels

N=103

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PatientViewsonUnderstandingof

theirConditionsbyHealthcareProviders

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

PatientViewsonUnderstandingoftheirConditionsbyProviders

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

11%

12%

11%

14%

12%

11%

13%

16%

15%

15%

16%

14%

16%

18%

17%

17%

22%

22%

21%

22%

23%

25%

23%

24%

26%

26%

26%

26%

26%

23%

22%

18%

27%

26%

27%

25%

23%

23%

25%

25%

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

3.3 493

3.2 445

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

Slide1of2

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Patientswereonaveragemostlikelytofeelthattheirprovidersunderstoodtheirsymptomsandtreatmentpreferences,butwerelesslikelytoperceivethattheirprovidersunderstoodtheimpactsoftheirconditionsontheirlivesandparticularlyontheirfamilyrelationshipsandabilitytocareforchildren.

PatientViewsonUnderstandingoftheirConditionsbyProviders

15%

17%

14%

20%

17%

20%

19%

24%

19%

15%

18%

17%

20%

19%

19%

14%

22%

25%

26%

18%

21%

20%

24%

28%

24%

23%

24%

17%

18%

21%

19%

20%

20%

20%

18%

27%

23%

21%

19%

15%

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?

Slide2of2

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

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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

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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)

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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)

21

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


22

Patientswhowererelieduponbyfamilymembersfordirectcareand/orfinancialsupportwerelesslikelythanotherstofeelwell-understoodbytheirmedicalcareproviders,whenitcametonearlyeveryaspectoftheirconditionsandlives.

PatientViewsonUnderstandingbyProviders:ByFamilyResponsibility


Yes (providescareorfinancial supporttofamilymembers)

No

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)

23

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


24

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


25

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


26

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


27

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


28

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)


29

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


30

Patients:ArethereaspectsofhowyourconditionortreatmentaffectsyouthatyoudoNOTsharewithyourhealthcareproviders?

UnderstandingofPatientsbyProviders

28%

72%

Yes

No

N=498

31

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

32

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

33

ConfidenceinInformationProvided

toClinicalTrialParticipants

34

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

Patients’ConfidenceinClinicalTrialParticipantInformation

3%

4%

3%

4%

7%

7%

6%

13%

9%

12%

8%

14%

7%

7%

9%

10%

11%

12%

14%

14%

16%

15%

17%

17%

19%

20%

19%

23%

17%

19%

25%

19%

23%

21%

25%

27%

19%

28%

29%

26%

24%

21%

28%

21%

26%

21%

25%

17%

51%

41%

40%

38%

41%

40%

27%

33%

25%

31%

24%

26%

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?

35

Typesofprocedures

Righttodropout

PossiblesideeffectsPossiblerisks

Possiblebenefits

Painordiscomfort

Privacyofpersonalinfo


Costs

Otherwaystogettreatment

Doctor'smotivations

Communicationofresults

3.0

3.5

4.0

4.5

5.0

3.0 3.5 4.0 4.5 5.0

Patie

nts

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

36

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

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


Typesofprocedures

Righttodropout

Possiblesideeffects

Possiblerisks

Possiblebenefits

Painordiscomfort



Costs

Otherwaystoget

treatment

Doctor'smotivations


3.0

3.5

4.0

4.5

5.0

3.0 3.5 4.0 4.5 5.0

Patie

ntsw

ithClinicalTria

lHistory


PatientswithClinicalTrialHistoryvs.AQCMemberConfidenceinClinicalTrialInformation

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

Typesofprocedures

Righttodropout

PossiblesideeffectsPossiblerisks

Possiblebenefits

Painordiscomfort



Costs

Otherwaystogettreatment

Doctor'smotivations


3.0

3.5

4.0

4.5

5.0

3.0 3.5 4.0 4.5 5.0

Patie

ntsw

ithou

tClinicalTria

lHistory



PatientswithoutClinicalTrialHistoryvs.AQCMemberConfidenceinClinicalTrialInformation

38

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)


39

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


40

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


41

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)

42

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


43

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)


44

ConfidenceinQualityofClinicalResearchProcess

45

3%

3%

4%

4%

8%

6%

9%

9%

12%

12%

18%

8%

9%

10%

9%

10%

13%

13%

14%

15%

17%

20%

19%

21%

20%

22%

21%

27%

21%

23%

26%

25%

23%

26%

27%

27%

25%

24%

23%

28%

28%

22%

20%

18%

43%

40%

39%

39%

37%

30%

29%

27%

25%

26%

22%

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?

46

3.0

3.5

4.0

4.5

5.0

3.0 3.5 4.0 4.5 5.0

Patie

nts


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

47

3.0

3.5

4.0

4.5

5.0

3.0 3.5 4.0 4.5 5.0

Patie

ntsw

ithClinicalTria

lHistory








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

Patientvs.AQCMemberConfidenceinSponsors’andPatients’ClinicalTrialComplianceandEthics


48

3.0

3.5

4.0

4.5

5.0

3.0 3.5 4.0 4.5 5.0

Patie

ntsw

ithou

tClinicalTria

lHistory









PatientswithNoClinicalTrialHistoryvs.AQCMemberConfidenceinSponsors’andPatients’ClinicalTrialComplianceandEthics

49

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

AQCMembers:PerceptionsofPatient-CentricThinking

PerceptionsofPatientCentricityinTrialDesign&ExecutionMeanRatings:1=NotWellAtAllto5=VeryWell

5%

5%

2%

2%

22%

12%

17%

7%

32%

28%

40%

27%

30%

31%

34%

40%

11%

23%

7%

23%

Sponsorsyouworkwith

Yourcompany

YourClinicalServiceProviders

Yourcompany

Mean

3.2

3.6

3.3

3.7

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

Sponsor

CRO

50

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)


51

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


52

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


53

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)

54

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)


55

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


56

Onaverage,patientswhowereresponsibleforprovidingdirectcareorfinancialsupportoffamilymembersweremoreskepticalaboutthecompliance,ethics,andcaringofthoseexecutingclinicaltrialsthanwerethosewhowerenot.

Patients’ConfidenceinTrialCompliance/Ethics:ByFamilyResponsibility


Yes (providescareorfinancial supporttofamilymembers)

No

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


57

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.”

58

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.’”

59

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.

60

PerspectivesonClinicalTrialParticipation

61

Nearlyhalfofthepatientsurveyedhadparticipatedinaclinicaltrial.Themostcommonreasonfordoingsowastheopportunitytocontributetoscience,followedbytheopportunitytolearnmoreabouttheirconditionsandbypaymentforparticipation.Themajorityofclinicaltrialparticipantsreportedfeelingmoreeducatedandinvolvedintheiroverallhealthasaresult.

PatientSurvey:ClinicalTrialParticipationRateandReasons

Whydidyoudecidetoparticipateintheclinicaltrial?

69%

51%

39%

21%

15%

15%

10%

2%

Opportunitytocontributetoscience

Opportunitytolearnmoreaboutmycondition

Iwaspaidtoparticipate

Accesstofreehealthcare

Morecontactwithdoctors/nursesthanIwouldotherwiseget

AccesstobetterdoctorsandhospitalsthanIwouldotherwisebeabletouse

Other

Influencedbymyfamily/friends65%14%

21% Yes

Notsure

No

N=302

45%55%

Yes

No

Haveyoueverparticipatedinaclinicaltrial?

N=582

Ifyes,didyoufeelmoreeducatedandinvolvedinyouroverallhealthasaresult?

N=260

62

52%

48%

36%

16%

0%

4%

12%

0%





Morecontactwithdoctors/nursesthanIwould…

AccesstobetterdoctorsandhospitalsthanIwould…

Other

Influencedbymyfamily/friends

71%

60%

36%

17%

17%

13%

9%

1%







Other


Whydidyoudecidetoparticipateintheclinicaltrial?byTypeofMedicalCondition

71%

47%

41%

24%

18%

16%

11%

3%






AccesstobetterdoctorsandhospitalsthanIwouldotherwisebe

abletouse

Other


N156

70

25

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

PatientSubsets:TypeofMedicalCondition

Chronic

Degenerative

Episodic

63

63%

48%

33%

28%

11%

17%

9%

0%







Other


72%

55%

39%

18%

17%

11%

6%

3%







Other


PatientSubsets:ImpactofMedicalCondition

Whydidyoudecidetoparticipateintheclinicaltrial?byImpactofMedicalCondition

70%

55%

36%

18%

15%

20%

15%

3%







abletouse

Other


N66

94

54

28

14

Severe

Moderate

Mild

Itvaries

None

Therewerealsodifferencesacrosspatientswithdifferentseveritiesofmedicalconditions.Althoughagainthetopthreereasonsfortrialparticipationwereallthesame,patientswithmilddiseaseweremorelikelytobeinfluencedbyaccesstofreehealthcarethanwerethosewithmoreseriousconditions,andthosewithnoimpactweremorelikelytobeinfluencedbypayment(seenextslide).

64

71%

36%

50%

14%

14%

7%

14%

0%







Other


PatientSubsets:ImpactofMedicalCondition(continued)

Whydidyoudecidetoparticipateintheclinicaltrial?byImpactofMedicalCondition

71%

50%

43%

29%

18%

14%

11%

4%







abletouse

Other


N66

94

54

28

14

Severe

Moderate

Mild

Itvaries

None

65

65%

53%

48%

25%

15%

23%

5%

0%







Other


PatientSubsets:EmploymentStatus

Whydidyoudecidetoparticipateintheclinicaltrial?byCurrentEmployment

74%

42%

32%

21%

15%

13%

10%

3%







abletouse

Other


N62

40

88

70

Fulltime

Parttime

Retired

No

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

66

71%

59%

34%

20%

11%

21%

11%

1%







Other


PatientSubsets:EmploymentStatus(continued)

Whydidyoudecidetoparticipateintheclinicaltrial?byCurrentEmployment

66%

50%

43%

19%

19%

7%

11%

3%







abletouse

Other


N62

40

88

70

Fulltime

Parttime

Retired

No

67

67%

51%

36%

19%

13%

7%

14%

2%







Other


PatientSubsets:AgeGroup

Whydidyoudecidetoparticipateintheclinicaltrial?byAge(onlycategorieswithN>10)

71%

57%

29%

21%

36%

14%

14%

0%







abletouse

Other


N

14

95

82

18

76+

61-75

46-60

31-45

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

68

72%

50%

33%

22%

17%

22%

6%

6%







Other


PatientSubsets:AgeGroup(continued)

Whydidyoudecidetoparticipateintheclinicaltrial?byAge

68%

55%

44%

24%

12%

17%

9%

1%







abletouse

Other


N

14

95

82

18

76+

61-75

46-60

31-45

69

64%

50%

31%

21%

17%

14%

10%

5%







Other


PatientSubsets:Sex

Whydidyoudecidetoparticipateintheclinicaltrial?bySex

71%

54%

41%

22%

13%

13%

11%

1%







abletouse

Other


N

150

58

Female

Male

Femalesingeneralendorsedmorereasonsforparticipatinginclinicaltrialsthandidmales,thoughtheoverallpatternoftopreasonswasthesame.

70

ThemajorityofbothAQCMembersandPatientsstatedthattheywouldrecommendclinicalresearchparticipationtoalovedoneorfriend,butmanyineachgroupstatedthattheyweren’tsure.Amongthosenotsure,severityofdiseaseandavailabilityofotheroptionswerevolunteeredascommentsforambivalence.

WillingnesstoRecommendClinicalResearchParticipation

82%

2%16% Yes

No

Notsure 67%4%

29% Yes

No

Notsure

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

Sponsor/CROAQCMembers Patients

71

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?

72

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?

73

AQCMemberSurvey:Perceptionsof

ClinicalResearchQuality

74

PerceptionsofQualityOverTimeThoughtherecontinuestobeadifferencebetweenCROsatisfactionwithqualitydeliveredandsatisfactionwithqualityreceivedamongSponsors,anupwardtrendinSponsorratingsisdrivingamovetowardsconvergenceatanoverallhigherlevelofsatisfactionwithqualitydeliveredascomparedto2012.

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

2%18%

5%

13%

5%

55%

54%

12%

36%

Sponsor CRO

5

4

3

2

1

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

75

SatisfactiononKeyRelationshipMetricsSponsorsandCROsarecloselyalignedintheirsatisfactionwithrelationships,howevertheydifferintheirperceptionofsatisfactionwithrespecttoquality,overallworkdeliveredandvalueformoney.

3.9

3.6

3.6

3.3

4.2

4.2

4.3

4.3

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.

77

Thankyou

ContactAvocaat:(609)252-9020

[email protected]

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