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Lesson3:ClinicalTrials

LearningObjectives
x Describeclinicaltrials
x Identifytherisksandbenefitsofclinicaltrials
x Discussstrategiesforhelpingpatientsunderstandclinicaltrials
x Identifyresourcesforpatientsonhowtolearnmoreaboutclinicaltrials
KeyTakeaways
x Thegoalofaclinicaltrialistofindbetterandsaferwaystoprevent,screenfor,
diagnoseortreatdisease.Aclinicaltrialmayalsolookforwaystoimprovepatients
qualityoflife.
x Thereare4phasesofclinicaltrials(PhaseIPhaseIV).
x Fewadultsparticipateinclinicaltrials.
x Participationinclinicaltrialsisvoluntary.
x Patientscanleaveaclinicaltrialatanytime.
x Federallawsprotecttherightsofresearchparticipants.
x Clinicaltrialsarenotrightforeveryone.
x Therearerisksandbenefitstoparticipatinginclinicaltrials.Patientsshouldbemade
awareofboth.
x Patientnavigatorshelppatientsunderstandclinicaltrialsingeneralanddonotprovide
informationaboutspecifictrialsandeligibilityorrecommendationsaboutparticipating.
x Commonpatientconcernsaboutclinicaltrialsarerelatedtoqualityofcare,new
treatmentnotworkingaswellasstandardtreatment,mistrustofmedicalresearchand
beingusedasaguineapigandgettingaplaceboinsteadofrealtreatment.


 

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LESSON3:CLINICALTRIALS

FAQsaboutClinicalTrials
PatientProtections
TheNavigatorRoleinClinicalTrials
HelpingPatientsUnderstandClinical
Trials
PossibleQuestionstoAskPatients
HowtoFindClinicalTrials
ResourcesforPatientNavigators
ResourcesforPatients

FrequentlyAskedQuestions(FAQs)AboutClinicalTrials

WHYARECLINICALTRIALSIMPORTANT?

Clinicaltrialsareimportantbecausetheyhelpusfindwaystoimprovepeopleshealth.
Advancesinmedicinearetheresultofdiscoveriesmadethroughresearch.Thetreatmentswe
usetodaywerefoundtobesafeandeffectivethroughclinicaltrials.

WHOARETHEPEOPLEINVOLVEDINACLINICALTRIAL?

Althoughresearcherscollectdataandstudyresults,theyarenottheonlypeopleinvolvedina
clinicaltrial.Clinicaltrialsrequireateamofdoctors,nurses,patientnavigators,pharmacists,
researchers,otherhealthcareteammembersandpatients.

WHATDOCLINICALTRIALSSTUDY?

Clinicaltrialsstudyavarietyofwaystofind,prevent,diagnoseortreatdisease:

Preventiontrialsexplorewaystokeeppeoplefromgettingadisease.Theyalsolookfor
waystokeepadiseasefromreturning.Thesestudiesmaylookatdiet,exercise,
preventivemedicine,vitamins,vaccinesorlifestylechanges.
Screeningtrialsstudythebestwaystodetectdiseasesorhealthconditions.
Diagnosistrialslookforbettertestsorprocedurestodiagnoseadiseaseorhealth
condition.
Treatmenttrialstestnewdrugs,treatments,surgeryoptionsorcombinationsof
treatments.
QualityofLifetrialslookforwaystoassessandimprovecomfortorqualityoflifefor
individualswithachronicdiseaseormedicalcondition.


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WHOPAYSFORACLINICALTRIAL?

Itdependsonthestudy.Everystudyisdifferent,sobesuretocheckwhocoversthecostsofa
specificclinicaltrial.Thecostsofaclinicaltrialcouldbecoveredbythe:

TheSponsorofthestudy:Someclinicaltrialcostsarepaidforbythesponsor,whichis
thegroupdoingthestudy.Thiscouldbethegovernment,adrugmakeroramedical
technologycompany.Theymaypayforthetreatment,specialtestsorextradoctor
visits.
TheInsurancecompany:Someclinicaltrialcostsmaybecoveredbythepatients
insurancecompany.Theseincluderoutinecarecostsforcarepatientswouldreceive
whetherornottheywereonaclinicaltrial.
Medicare:Medicarewillpayforroutinecarecostsformanyclinicaltrials,includingall
trialsfundedbytheNationalInstitutesofHealth,theCentersforDiseaseControland
theVeteransAffairsMedicalsystem.Routinecarecostsarecostsofcarepatientswould
receivewhetherornottheyareonaclinicaltrial.
ThePatient:Patientsmayneedtopaysomecostsnotcoveredbythesponsororthe
insurancecompany,buttheAffordableCareActnowrequirescommercialhealth
insuranceplansandtheFederalEmployeeHealthBenefitsPlantocoverroutinecare
costsformanyclinicaltrials.

CANAPATIENTGETPAIDTOBEINACLINICALTRIAL?

Sometimes.Payingpatientstobeinastudycanbeunethical.However,someclinicaltrialspay
smallamountsofmoneyforcostsrelatedtotheclinicaltrialsuchastravelordaycare
expenses.

DOPATIENTSINACLINICALTRIALSTILLSEETHEIROWNDOCTOR?

Generallytheanswerisyes.Thepatientsprimarycaredoctororspecialistwilllikelyfollow
theircareclosely.Patientswillhaveregularappointmentswiththeirdoctortoseehowthenew
treatmentisworkingandtomakesurethatitdoesnotconflictwithothermedicinesor
treatments.

CANAPATIENTLEAVEACLINICALTRIALAFTERITSTARTS?

Yes.Apatientcanleaveaclinicaltrialatanytime.Ifapatientdecidestoleaveaclinicaltrialitis
importantthattheytalktothedoctorfirst.Thedoctorneedstoknowsotheycan:

Makesuretherearenoharmfuleffectsofstoppingtreatment
Helpthepatientchooseadifferenttreatment
Letresearchersknowaboutanyproblemswiththetreatment
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Monitorthepatientstreatment(somemedicationshaveharmfuleffectsifapatient
suddenlystopstakingthem)

CANSOMEPATIENTSGETAPLACEBOORSUGARPILLINSTEADOFREALTREATMENT?

Yes,sometimes;butthisisveryrareinacancerclinicaltrial.Ifaplaceboisusedinacancer
clinicaltrial,thiswillbepartoftheinformationapatientreceivesbeforetheyconsentto
participateinthetrial.Aplacebo,sugarpill,orfakepillisamedicinethathasnoeffect.
Placebosarenotusedwhenpatientsneedrealtreatment.However,ifthereisnoknown
effectivetreatmentforacondition,aplacebomaybeused.Inthiscase,onegroupofpatientsis
giventheplaceboandtheothergroupisgiventhenewtreatment.Mostcancertreatment
clinicaltrialsprovidethecurrentstandardofcareasacomparison,meaningthatonegroupof
patientswillgettheusualtreatmentandanothergroupwillgettheexperimentaltreatment.
Experimentaltreatmentsarealwaystestingwhatresearchersthinkwillbeanimprovementto
thestandardofcare.

IFAPATIENTCHOOSESNOTTOPARTICIPATEINACLINICALTRIAL,WILLHEORSHEBE
TREATEDDIFFERENTLY?

No.Itisentirelythepatientschoicetoparticipateinatrialornot.Thepatientshouldnotbe
treatedanydifferentlybyhisorherhealthcareproviders.

Thesearesomeclinicaltrialparticipationfacts:

Participationinclinicaltrialsisvoluntary
Patientscanleaveaclinicaltrialatanytime
Federallawsprotecttherightsofresearchparticipants
Clinicaltrialsarenotrightforeveryone

WHICHPATIENTSCANJOINACLINICALTRIAL?

Itdependsonthestudy.Clinicaltrialsarescientificexperimentsandhavestrictrequirements
forwhocanjoin.Requirementsmaybebasedonmanyfactorssuchasage,gender,diseaseor
treatmenthistory.Ifapatientiseligibleforaclinicaltrial,itmeansthattheymeetthe
requirementsforwhocanparticipateinthatstudy.Althoughclinicaltrialshaveeligibility
requirements,itisalsoimportantthattheyincludeawidevarietyofpatients.

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WHYDOCLINICALTRIALSNEEDAVARIETYOFPEOPLETOPARTICIPATE?

Clinicaltrialsneedawidevarietyofpeopletoparticipatesothatresearchersknowthata
treatmentworksonpeoplewithdifferentcharacteristics.Ifanewtreatmentworksbutisonly
testedononegroupofpeople,weknowitworksforthatgroup,butitmaynotworkforothers.
Forexample,ifaclinicaltrialtestsanewmedicationonlyonyoungAsianfemales,wecanlearn
howwellitworksforyoungAsianfemales,butwedontknowhowwellitworksforotherage
groups,racesormales.

WHYISITIMPORTANTTOINCLUDEUNDERSERVEDPATIENTSINCLINICALTRIALS?

Underservedpatientsmaybepeopleinaracialorethnicminoritygrouporpeoplewhohave
lowincomeorloweducation.Olderadults,peoplewholiveinruralareasorpatientswhohave
acomorbidity,whichmeansmorethanonedisease,canalsobeunderserved.Theymustbe
includedintrialssoweknowwhethertreatmentoptionsworkforthatpopulation,and
historicallythesepopulationshaveoftenbeenleftoutoftherapeutictrials.

WHYARENAVIGATORSIMPORTANTTOUNDERSERVEDPATIENTS?

Clinicaltrialsusuallyrequirethatpatientshavehealthinsurance,anaddressandaphone
number.Underservedpatientsdonotalwaysmeettheserequirements.Thisiswhyapatient
navigatorissoimportant:youmayneedtoaddressbarrierstohelpunderservedpatientsjoin
andstayinaclinicaltrial.

RISKS

Newtreatmentsarenotalwaysbetterormaynotworkaswellastreatmentsalready
beingused
Newtreatmentsmayhaveunexpectedorworsesideeffectsthancurrenttreatments
Patientsinaclinicaltrialmayhavemoredoctorvisits,proceduresortests
Somecostsmaynotbecoveredbyhealthinsuranceorthestudyssponsorbutthe
AffordableCareActrequirescoverageformanyofthesecostsbymanyinsurers,sobe
suretodoublecheckifcostscanbecovered

BENEFITS

Newtreatmentsmaybemoreeffectiveorsaferthanthecurrenttreatments
Patientsinaclinicaltrialmaybethefirsttobenefitfromnewtreatmentsbeforethey
arewidelyavailable
Patientsgethighqualitycareandarecloselyfollowedbydoctorsandotherhealth
professionals

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Patientscanhelpothersbybeingpartofmedicalresearch

Patientsafetyandprotectionisveryimportantinclinicaltrials.Beforeaclinicaltrialis
approved,itgoesthroughanethicalreviewprocess.Researchersmustcomplywithlawsthat
protectandinformpeoplewhotakepartinresearchstudies.Thisisimportanttonotebecause
inthepast,therewerenoguidelinesorlawstoprotectpeoplefromharmfulresearchstudies.
Somepeoplewereforcedtobeinresearchstudies.Othersagreedtotakepartinresearchbut
werenotgiventreatmentorinformationabouttheirillness.

PatientProtections

Thereareseveralproceduresandlawsthatprotectpatientsfromunethical,orabusive,
treatmentinaclinicaltrial.Protectionsinclude:

MEDICALETHICS:Becauseofunfairandabusivepastresearch,thegovernmentandmedical
groupscreatedmedicalethicsprinciplesthataredescribedinwhatscalledtheBelmont
Report.
x RESPECTFORPERSONS:Participantsshouldbetreatedwithcourtesyandrespect.
x BENEFICENCE:Researchersshouldseektomaximizebenefitsandminimizerisksto
participants.
x JUSTICE:Researchersshouldensurethatresearchisfairandbenefitsthe
participants.

SCIENTIFICREVIEW:Beforeaclinicaltrialbegins,thestudymustbereviewedbyagroupof
researchers,doctorsandotherprofessionalstodetermineifthestudyissafe,ethicaland
welldesigned.ThescientificreviewisdonebyagroupcalledanInstitutionalReviewBoard,
orIRB.AnIRBisacommitteeofpeoplewherethestudyistakingplace.ThegoalofanIRBis
toprotectpatientsafety.Theydothisbyreviewing,approvingandcheckingonclinical
trials.FederallawrequiresIRBsforresearchdoneonhumansandtherearestrictrules
aboutwhocanserveonanIRBandhowIRBsarerun.Someinstitutionshaveadditional
reviewcommitteesthatmustalsoapproveastudy.

STRICTRESEARCHPROTOCOLS:Clinicaltrialsfollowverystrictrulesabouthowtheyare
carriedout.Theserulesarespelledoutinadocumentcalledaresearchprotocol,adetailed
planaboutwhatresearchersanddoctorswilldoinastudy.


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INFOORMEDCONSSENT:Federrallawsrequ uirethatpatiientsgivethheirinformed dconsentto
o
particcipateinaclinicaltrial.TThismeanstthattheyareeinformedo ofthestudysprocedurees,
risksandbenefitss,andtheyaagree,orgivveconsent,ttoparticipate.Sometimeespatientsggive
verbaalinformedcconsenttop participatein nastudyifttheprimaryrisktotheppatientis
disclo
osureofhis//heridentityy.Usually,ap patientgivessinformedcconsentbyssigninga
documentthatsttatesthatth heyunderstaand:
Thepurposeofth heclinicaltrial
Whatwillhappen nduringtheclinicaltrial
Beneffitsandriskss
Patien ntsrightsanndwhotoco ontactifthepatienthasquestionso orfeelstheyhave
beenmisttreated
Rulesthatguideinformedcon nsentareveerystrict.Itisimportantthatpatientts
understan ndtheclinicaltrial.Forp patientswhoodonotspeeakEnglish,ttheinformed d
consentformmustbe ewrittenintheirlanguaage.

Sources: National Cancer
C Instittute. Clinicaal Trials. 20013; Centerss for Mediccare & Meddicaid
Services.2000;PNTC C.

TheNaviigatorRoleiinClinicalTrrials

Yes Maaybe No

Increaasepatient Explaincliinicaltrials Enncouragepattientsto

intere
est (yesifgenneral joiinclinicaltrial
Reducebarriers informatio on;noif Deecideifapattientcan
clinicalinfformationorr joiinaclinicalttrial
informatio onabouta Proovidedetailssabout
specifictrrial) asspecifictrial

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HelpingPatientsUnderstandClinicalTrials

Verbalinformation

Takenotes
Checkunderstanding
TeachbackTellmewhatyouknowaboutthistrial
OpenendedquestionsHowdoyoufeelaboutjoining
Connectpatientstoclinicalcoordinator

Writteninformation

Consultwithclinicalcoordinatorforanswers
Reviewwrittenmaterialswithpatients
Writedownmedicaltermdefinitions 
PossibleQuestionstoAskPatients

x Whatconcernsyouaboutthisclinicaltrial?
x Howcouldthisclinicaltrialbegoodforyou?
x Whatdoyouthinkaretherisks?
x Whataboutthisclinicaltrialmaystopyoufromenrolling?
x Whatdoyouhearaboutclinicaltrialsthatworriesyou?
x Whatdoyouneedtoknowtofeelmorecomfortableaboutenrollinginthisclinicaltrial?

Source:PNTC.

 

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HowtoFindClinicalTrials

TheNationalCancerInstituteoffersa10stepguideonHowtoFindaCancerTreatmentTrial.It
goesintodetailonthefollowingsteps:

x Step1:UnderstandClinicalTrials
x Step2:TalkWithYourDoctor
x Step3:CompletetheChecklist
x Step4:SearchNCIsListofTrials
x Step5:OtherListsofTrials
x Step6:IdentifyPotentialTrials
x Step7:ContacttheTrialTeam
x Step8:AskQuestions
x Step9:TalktoYourDoctor
x Step10:MakeanAppointment

Otherresourcesforfindingclinicaltrialsinclude:

x SearchingtheNationalCancerInstituteclinicaltrialsdatabaseor8004CANCERto
speakwithsomeonewhocanhelp.
x AccessingtheAmericanCancerSocietysClinicalTrialsMatchingServicethatisavailable
byphoneat8003035691.
x SearchingclinicaltrialsthroughtheNationalInstitutesofHealthclinicaltrialsdatabase
atClinicaltrials.gov.

 

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ResourcesforPatientNavigators

x MedicaresCoverageIssuesManualClinicalTrials
ThissectionofthemanualreviewsMedicaresclinicaltrialscoverage.
x PatientNavigatorTrainingCollaborativesClinicalTrialsandPatientNavigation
Thiscourseaddressestherolethatpatientnavigatorsplayinclinicaltrials.Navigators
helppatientsunderstandhowclinicaltrialswork,supportpatientsastheydecide
whetherornottojoinaclinicaltrial,thenhelppatientsaddressbarriersthatmaykeep
themfromjoiningaclinicaltrial.

ResourcesforPatients

x OncoLinksClinicalResearchTrials:TheBasics
Thiswebpageprovidesbasicinformationaboutclinicaltrials.
x NationalCancerInstituteClinicalTrials
TheNationalCancerInstituteoffersavarietyofinformationonclinicaltrialsandenables
userstofindaclinicaltrialandclinicaltrialsresults.
x NationalCancerInstitutesPayingforClinicalTrials
Thissectionofthewebsiteprovidesinformationaboutinsurancecoverage,working
withinsuranceplansandfederalgovernmentprogramsrelatedtoclinicaltrials.
x Cancer.netsPREACT
PREACT(PreparatoryEducationAboutClinicalTrials)isaneducationalprogram
designedtoprovidegeneralinformationaboutclinicaltrials.
x Cancer.netsDecidingtoParticipateinaClinicalTrial
Thiswebpagehasinformationabouttherisksandbenefitsofparticipating,patient
storiesandavideoonclinicaltrialsasatreatmentoption.


 

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Module3,Lesson3:ClinicalTrials

References:Presentation

CentersforMedicare&MedicaidServices.MedicareCoverageIssuesManual.2000.Retrieved
from:http://www.cms.gov/Regulationsand
Guidance/Guidance/Transmittals/downloads/R126CIM.pdf.

MetzJ,VachaniC.ClinicalResearchTrials:TheBasics.2014.Retrievedfrom:
http://www.oncolink.org/treatment/article.cfm?c=148&id=170.

NationalCancerInstitute.TreatmentandClinicalTrials.2015.Retrievedfrom:
http://www.cancer.gov/cancertopics/aya/treatment.

NationalCancerInstitute.ClinicalTrials.n.d.Retrievedfrom:
http://www.cancer.gov/clinicaltrials.

NationalInstitutesforHealth.[NIH4Health].2008.CancerClinicalTrials:WhatisaClinicalTrial?
[Videofile].Retrievedfrom:https://www.youtube.com/watch?v=ZxwKggJ2ACs.

PatientNavigatorTrainingCollaborative.n.d.Retrievedfrom:
http://patientnavigatortraining.org/.

WillisA,ReedE,PrattChapmanM,etal.Developmentofaframeworkforpatientnavigation:
Delineatingrolesacrossnavigatortypes.JournalofOncologyNavigation&Survivorship.2013;
4(6):2026.

References:BriefQuizrence:PostTest

AmericanSocietyofClinicalOncology.DecidingtoParticipateinaClinicalTrial.2013.Retrieved
from:http://www.cancer.net/navigatingcancercare/howcancertreated/clinical
trials/decidingparticipateclinicaltrial.

MetzJ,VachaniC.ClinicalResearchTrials:TheBasics.2014.Retrievedfrom:
http://www.oncolink.org/treatment/article.cfm?c=148&id=170.

NationalCancerInstitute.ClinicalTrials.n.d.Retrievedfrom:
http://www.cancer.gov/clinicaltrials.

NationalCancerInstitute.TreatmentandClinicalTrials.2015.Retrievedfrom:
http://www.cancer.gov/cancertopics/aya/treatment.

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NationalInstitutesforHealth.[NIH4Health].2008.CancerClinicalTrials:WhatisaClinicalTrial?
[Videofile].Retrievedfrom:https://www.youtube.com/watch?v=ZxwKggJ2ACs.

PatientNavigator2011TrainingCollaborative.ClinicalTrialsandPatientNavigation:Atutorial
forpatientnavigators.Retrievedfrom:http://www.patientnavigatortraining.org/clinical_trials/.

WillisA,ReedE,PrattChapmanM,KappH,HatcherE,VaitonesV,CollinsS,BiresJ,Washington
E.Developmentofaframeworkforpatientnavigation:Delineatingrolesacrossnavigatortypes.
JournalofOncologyNavigation&Survivorship.2013;4(6):2026.

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