hbv clinical trials and why they are...
TRANSCRIPT
HBVClinicalTrialsandWhyTheyAreImportant
Presenters:RobertG.Gish,MD,FAASLDMoonS.Chen,Jr,PhD,MPH
WhatIsaClinicalTrial?
• Studiesinwhichpeoplevolunteertotestnewdrugsordevices
• Learnwhethernewtreatmentworksandissafeforpeople
• TherapiesinclinicaltrialsNOTthesameasavailabledrugs(rouCnecare)– Availabletherapieshavebeentested&approved
WhyAreClinicalTrialsImportant?
• NewtreatmentsmustpassmanytestsbeforetheygettopaCents
• Canadvancescienceandhelpothersinthefuture
• OtherconsideraCons:– PaCentsmayaccesstherapiesindevelopment– Tests,treatmentusuallyfreeforstudyvolunteers– PaCentsmaybeobservedmorecloselyduringtrial
WhatDoestheHealthcareProviderDoinClinicalTrials?
• Physician(principalinvesCgator,PI)– Organizes&directsthestudy– Reviewsthedata
• Clinicalresearchcoordinator– Handlesday-to-dayacCviCes– MaincontactforpaCents
ImagecourtesyofstockimagesatFreeDigitalPhotos.net
HowtoFindHBVClinicalTrials
• LocalacademicandnonacademicinsCtuCons• Pharmacompanies’websitelisCngs
ClinicalTrials.gov-listsallclinicaltrials
HepaHHsBFoundaHon(www.hepb.org)- [email protected] Call215-489-4900- HBVspecificlisCng- ProvidescontactinformaConfortrialsite
(contactresearchteam)
HowtoFindHBVClinicalTrials
• 1-877-MEDHERO(www.ciscrp.org)• Freeservicetohelpfindappropriateclinicaltrialslocallyorfurtheraway
-SendyoucontactinformaConforresearchstudies• e-mail:~1week;regularmail:2weeks
• FreeeducaConalbrochure(keyquesConstoaskresearchstaff)• CanalsosearchtheirCenterWatchclinicaltrialsdatabaseyourself
CenterforInformaHon&StudyonClinicalResearchParHcipaHon
HowCanHealthcareProvidersGetInvolvedinaTrial?
• CreatedatabaseofpaCentsintheirpracCce– viraldisease,liverdisease,demographics
• PublisharCcleontheirpaCentprofile• Approachpharmacompanies• Establisharesearchinfrastructure• Publish
IfHealthcareProviderIsNotInvolvedinaClinicalTrial
Ifaproviderisnotinvolvedinatrialbuthis/herpaCentwantstoparCcipate:• Referraltoresearchcenter• Submitintakeformifavailable• Transferrecordsa^ercompleCngHIPAAforms
• CansCllremaininvolvedinpaCent’scare
BarrierstoParCcipaCnginClinicalTrials
TheHealthcareProviderPerspecHve
ClinicalTrialsCanAffectPracCce
Sometrialscanrunmonths,years• EstablishprotectedCmeforclinicaltrials• Allocatestaffjustforclinicaltrials• BudgetownCmeandstaffCmetobalancethebusinessaspectofdisease
OtherBarrierstoClinicalTrials
• Lackofawarenessaboutnewdrugs,trials• LackofurgencyforpaCentstoentertrial– 7effecCvetreatmentsavailable
• SubstanCalcostsassociatedwithclinicaltrials
HealthcareProviderConcerns
• PaCentsmaynotwanttoparCcipate• PaCentsmaynotadheretoprotocol– Language,culturalbarriers– TakeCmeoffwork,needtotraveltotrialsite
• MaylosepaCentstoclinicaltrialsite
KeyMessagesforHealthcareProvidersAboutHBVClinicalTrials
TobuildadatabaseofHBVpaCents,providersmusttakethefollowingsteps:
1. TestforHBVinallat-riskpaCents2. TestforanC-HBc;ifposiCvedonotvaccinate;
educateaboutriskofreacCvaCon3. PreventHBVwithvaccinaConifallthreeHBV
testsarenegaCve
KeyMessagesforPaCentsAboutClinicalTrials
1. CurrentlynocureforHBVinfecCon2. ExisCngtreatments:lifelong,havesideeffects3. NewdrugswithpotenCallyshortertherapyandgreater
effecCvenesscouldpreventhepaCCsB-related:a. deathsb. livertransplantsc. livercancer
TalkingAboutClinicalTrials:
StrategiestoPromoteandMoCvate• TalkingtoindividualswithHBV
– Face-to-facemeeCngsaboutHBVbederthantelephonediscussions
– Useenduringmaterials,pictures,graphics,videos
• Talkingtohealthcareproviders– WHOplantoeliminateHBVworldwideby2030– MenConthe30+newtherapiesindevelopmentforHBV,withthenextstepbeingafuncConalcure
YourRolesinIncreasingAsianAmericans’ParHcipaHonin
HBVClinicalTrials
MoonS.ChenJr.,PhD,MPHCo-Founder,NaHonalTFonHBV:
FocusonAPIsProfessor&AssociateDirectorfor
CancerControlUCDavisComprehensiveCancer
Center
ObjecCves
FromReviewtoRealiza,on
FromRealizaHonto
Responsibili,es
FromResponsibiliHestoRoles
ObjecCves
FromReviewtoRealiza,on
AsianAmericanCancerMortalityTrendsReportedByRace/Ethnicity
Table1.Top5sitesofcancer-relatedmortality,rankedasaproporConofallcancerdeaths,byrace/ethnicity(2003–2011)
Thompson,C.A.,Gomez,S.L.,HasCngs,K.G.,Kapphahn,K.,Yu,P.,Shariff-Marco,S.,…Palaniappan,L.P.(2016).TheBurdenofCancerinAsianAmericans:AReportofNaConalMortalityTrendsbyAsianEthnicity.CancerEpidemiology,Biomarkers&PrevenCon:APublicaConoftheAmericanAssociaConforCancerResearch,CosponsoredbytheAmericanSocietyofPrevenCveOncology,25(10),1371–1382.hdps://doi.org/10.1158/1055-9965.EPI-16-0167
AsianAmericanswithChronicHBV
Asian Americans 6%
USDEMOGRAPHICS
Ourcancerburdenisunique,because,amongallracialgroupsintheUnitedStates,AsianAmericanswerethefirsttoexperiencecancerastheleadingcauseofdeath.Inallotherracialgroups,heartdiseaseistheleadingcauseofdeath.
ThecancerburdenthataffectsAsianAmericansis
unusual,becausemorethananyotherracial/ethnicgroup,AsianAmericansexperienceproporHonallymorecancersofinfec,ousorigin,suchaslivercancer,cervicalcancer,andstomachcancer.
7.6
12.8
12.9
13.9
14.5
0 5 10 15 20
Non-HispanicWhite
Non-HispanicBlack
Hispanic
AmericanIndian/AlaskaNaCve
Asian/PacificIslander
Liver&IntrahepaCcBileDuctCancerMortalityRatesforMales
USA,2008-2012per100,000
SiegelRLetal.CancerStaCsCcs,2016;CACancerJCln2016;66:7-30
3.1
4.4
5.6
6.1
6.3
0 1 2 3 4 5 6 7
Non-HispanicWhite
Non-HispanicBlack
Hispanic
Asian/PacificIslander
AmericanIndian/AlaskaNaCve
Liver&IntrahepaCcBileDuctCancerMortalityRatesforFemalesUSA,2008-2012Per100,000
SiegelRLetal.CancerStaCsCcs,2016;CACancerJCln2016;66:7-30
ThecancerburdenthataffectsAsianAmericansmaybe
unnecessary,atleastinpart,becauseprevenHonisbederthanacureandearlierdetecHonandotherbehavioralchangescanreducetheriskofdyingfromcanceroracquiringcancer.
ObjecCves
FromRealizaHonto
Responsibili,es
ReducingCancerHealthDispariCesAmongAsianAmericans:Progress&Prognosis
Kaplan-MeierCurvesofCauseSpecificSurvivalfromHCC
ThousandAsianAmericanStudy(TAAS)
Clinical Trials
YouTubeLink
PerspecCves
Paradigm
TOOLS
TRUSTWORTHINESS
TANGIBLEBENEFITS
TIME
TRUST
PaCent’sPerspecCve
DEMOGRAPHICS
SOCIALCULTURAL
AGE
VALUES
HERITAGE
COMMUNICABILITY
FACILITATORS HOW: • Doctor-recommended
• Trust earned • Cultural sensitivity
• Linguistic competence
Yes,minoriHesarewillingtoparHcipateinhealth
research
BrownM,MoyerA.Predictorsof
awarenessofclinicaltrialsandfeelingsabouttheuseof
medicalinformaConforresearchinanaConally
representaCveUSsample.EthnicHealth.2010;15:223-226.
TongEK,FungLC,StewartSL,PaterniC
DA,DangJHT,ChenMSJr.Impactofa
biospecimencollecConseminaronwillingness
todonatebiospecimensamongChineseAmericans:
Resultsfromarandomized,controlledcommunity-basedtrial.
CancerEpidemiolBiomarkers,&PrevenCon2014
DangJHT,RodriguezEM,LuqueJS,ErwinDO,MeadeCD,ChenMSJr.Engagingdiverse
populaConsaboutbiospecimendonaConforcancerresearch.JournalofCommunity
GeneCcs2014
Yes,TRUSTisthekey
DoesThisWork?
ObjecCves
FromReviewtoRealiza,on
FromRealizaHonto
Responsibili,es
FromResponsibiliHestoRoles
AsianAmericanCommunityResponsestoBlood
BiospecimenDrives:FindingsandImplicaCons
The3R’s:RolesandResponsibiliCes
RecommendclinicaltrialstoyourpaCents
Ifyouare: YourresponsibiliCesare:
PersonwithHBV
Requestthatyourproviderinformyouaboutclinicaltrials
Publichealthorcommunitygroup….
BeaResourceforlinkingprovidersandpaCentstoclinicaltrials
Healthcareprovider….
HowtoFindHBVClinicalTrials• Clinicaltrials.gov• HepaHHsBFoundaHon– [email protected]– 215-489-4900
• CISCRP(SearchClinicalTrials)– 1-877-MEDHERO(www.ciscrp.org)
• Localacademic/nonacademicinsCtuCons• PharmaceuCcalcompanywebsites