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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