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The Critical and Growing Importance of Equity in Clinical Trials
Sandy AmaroDiversity in Clinical Trials Operations DirectorPfizer
Cassandra SmithAssociate Director, Diversity & Inclusion in Clinical Trials LeadJanssen
RADM Richardae AraojoAssociate Commissioner for Minority Health, Director, Office of Minority Health and Health EquityFDA
Diana FosterVP, Strategy & Special ProjectsSociety for Clinical Research Sites October 7, 2020
Faculty Disclosure• In compliance with ACCME Guidelines, I hereby declare: I do not have financial or other relationships with the manufacturer(s) of any
commercial services(s) discussed in this educational activity.
Sandy Amaro, Diversity in Clinical Trials Operations Director, PfizerCassandra Smith, Associate Director, Diversity & Inclusion in Clinical Trials Lead Janssen
RADM Richardae Araojo, Associate Commissioner for Minority Health, Director, Office of Minority Health and Health Equity, FDA
Diana Foster, VP, Strategy & Special Projects, Society for Clinical Research Sites
SCRS Diversity HistoryFDA Perspective
Sponsor PerspectiveDiversity Site Assessment Tool (DSAT)
Summary and Conclusion
Overview of Discussion
The Importance of Diversity Inclusion and Equity Now and in the Future
• Regulatory Perspective
• Sponsor Requirements
• Changing Populations/ Demographics/ Culture
• Establishing Knowledge and Best Practices
• Assessment and Evaluation of Sites Changes in Perception and Behaviors Regarding Diversity
The SCRS Diversity Project
To Support Site Sustainability in Regard to Building Knowledgeand Ability to Execute in Enrolling Diverse Populations in Clinical Trials
Acknowledgment of Funding Sponsors
SUPPORTINGSPONSORS
CONTRIBUTORS
PATRONS
MovingThe Needle –SCRSDiversityProject
2016ConceptderivedMerck,Janssen,PhARMASupportprojectfundingAdvocatesgatheredforprojectdirection
2017Planofworkfor24monthsWorkinggroupestablishedOnescientificpaperpublishedWebinarseriesbegins
2018SiteAssessmentToolBestPractices–HighPriorityFDAon-boardWorkinggroupgrowsFundingpartnersexpandLargersurveypaperpublishedMultiplepresentationsgivenMOUDepartment
2019GlobalPerspectiveExpandedPresentations/globalworkinggroupsplannedforAsiaPAC,US,andEuropeRoche,Parexel andVirTrial becomeadditionalpartnersGovernmentinvolvementexpandsNIHR participatesThirdpaperpublishedNewpartnerSyneos
2020 and BeyondMoving the
Needle – The Future Direction of the Diversity
Project
Thefuturewillbringongoingquestionsofsignificancethatwilldirectlyimpacttheclinicalresearchsite.Theelementof
demographics,governmentandsponsorexpectations,willbecomeofevengreaterimportancetositesasdiversepopulations
expand
Thank YouSandra Amaro – sandra.amaro@pfizer.com
RADM Richardae Araojo – richardae.araojo@fda.hhs.gov
Diana Foster – diana.foster@myscrs.org
Cassandra Smith – csmith52@its.jnj.com
The Critical and Growing Importance of Equity in Clinical Trials
Sandy AmaroDiversity in Clinical Trials Operations DirectorPfizer
Cassandra SmithAssociate Director, Diversity & Inclusion in Clinical Trials LeadJanssen
RADM Richardae AraojoAssociate Commissioner for Minority Health, Director, Office of Minority Health and Health EquityU.S. FDA
Diana FosterVP, Strategy & Special ProjectsSociety for Clinical Research Sites
October 7, 2020
Faculty Disclosure• In compliance with ACCME Guidelines, I hereby declare: I do not have financial or other relationships with the manufacturer(s) of any
commercial services(s) discussed in this educational activity.
Sandy Amaro, Diversity in Clinical Trials Operations Director, PfizerCassandra Smith, Associate Director, Diversity & Inclusion in Clinical Trials Lead Janssen
RADM Richardae Araojo, Associate Commissioner for Minority Health, Director, Office of Minority Health and Health Equity, FDA
Diana Foster, VP, Strategy & Special Projects, Society for Clinical Research Sites
PanelistDiana Foster, Ph.D.Vice President, Strategy and Special Projects, SCRS
RADM Richardae Araojo
Associate Commissioner for Minority Health, Director, Office of Minority Health andHealth Equity, FDA
Cassandra SmithAssociate Director, Diversity and Inclusion in Clinical Trials Lead, Janssen
Sandra Amaro
Diversity in Clinical Trials, Operations Director, Pfizer
SCRS Diversity HistoryFDA Perspective
Sponsor PerspectiveDiversity Site Assessment Tool (DSAT)
Summary and Conclusion
Overview of Discussion
The Importance of Diversity Inclusion and Equity Now and in the Future
• Regulatory Perspective
• Sponsor Requirements
• Changing Populations/ Demographics/ Culture
• Establishing Knowledge and Best Practices
• Assessment and Evaluation of Sites Changes in Perception and Behaviors Regarding Diversity
The SCRS Diversity Project
To Support Site Sustainability in Regard to Building Knowledgeand Ability to Execute in Enrolling Diverse Populations in Clinical Trials
Acknowledgment of Funding Sponsors
SUPPORTINGSPONSORS
CONTRIBUTORS
PATRONS
MovingThe Needle –SCRSDiversityProject
2016ConceptderivedMerck,Janssen,PhARMASupportprojectfundingAdvocatesgatheredforprojectdirection
2017Planofworkfor24monthsWorkinggroupestablishedOnescientificpaperpublishedWebinarseriesbegins
2018SiteAssessmentToolBestPractices–HighPriorityFDAon-boardWorkinggroupgrowsFundingpartnersexpandLargersurveypaperpublishedMultiplepresentationsgivenMOUDepartment
2019GlobalPerspectiveExpandedPresentations/globalworkinggroupsplannedforAsiaPAC,US,andEuropeRoche,Parexel andVirTrial becomeadditionalpartnersGovernmentinvolvementexpandsNIHR participatesThirdpaperpublishedNewpartnerSyneos
2020 and BeyondMoving the
Needle – The Future Direction of the Diversity
Project
Thefuturewillbringongoingquestionsofsignificancethatwilldirectlyimpacttheclinicalresearchsite.Theelementof
demographics,governmentandsponsorexpectations,willbecomeofevengreaterimportancetositesasdiversepopulations
expand
SCRS Site Solutions Summit:
The Critical and Growing Importance of Equity in Clinical TrialsRADM Richardae Araojo, PharmD, MS
Office of Minority Health and Health Equity
www.fda.gov/healthequity
Disclaimer
• ThispresentationrepresentsthepersonalopinionsofthespeakeranddoesnotnecessarilyrepresenttheviewsorpoliciesofFDA
• Noconflictsofinteresttodeclare
FDAOfficeofMinorityHealthandHealthEquity(OMHHE)
MissionTo promote and protect the health of diverse populations through research and communication that addresses health disparities.
VisionTo create a world where health equity is a reality for all.
FDAOMHHEGoals
Goal1: Improveregulatorysciencebyincreasingclinicaltrialdataavailable onracialandethnicminorities;improvedataqualitytodetermine howminoritiesreacttomedicalproducts;andincrease transparencyandaccesstoavailabledata
Goal2: StrengthenFDA’sabilitytorespondtominorityhealthconcerns
Goal3: Promotehealthandsafetycommunicationtominoritypopulationswhooftenexperiencelowhealthliteracyand/or
speakEnglishasasecondlanguage
WhatWeDo
ResearchandCollaboration
• Programs/Initiatives/Campaigns• DiversityinClinicalTrialsInitiative
• LanguageAccessProgram• HealthEducationMaterials• SocialMedia• Newsletter&E-alerts• Website• HealthEquityLectureSeries&Webinars
• FDA&HHSWorkingGroups&Collaborations
OutreachandCommunication
• IntramuralResearch• ExtramuralResearch• FDACentersofExcellenceinRegulatoryScienceandInnovation(CERSI)Projects
• BroadAgencyAnnouncement(BAA)
• Otherresearchopportunities• SummerScienceTeacherTrainingProgram
• InternshipsandFellowships• AcademicCollaborations
PriorityAreas
• COVID-19• ClinicalTrialDiversity• Opioids• RareDiseases• CardiovascularDisease• Diabetes• KidneyHealth
• Nutrition&FoodSafety• Hepatitis• HIV/AIDS• Tobacco• Cancer• Men’sHealth
• LanguageAccess
BarrierstoDiverseParticipation
• Mistrustanddistrustofthemedicalsystemduetohistoricalabuses
• Lackofawarenessofwhataclinicaltrialisandwhatitmeanstoparticipate
• Inadequaterecruitmentandretentionefforts
• Lackofminorityphysicians,researchers,andclinicalinvestigators
• Misunderstandingofracial/ethnicminorities’beliefsandvaluesthatcontributetotheirdecisionmakingprocess
• Lackofculturallyandlinguisticallyappropriatecommunication
• Perceptionthatracial/ethnicminoritiesdonotwanttoparticipate
• Physicians/providersmaynottalktotheirpatientsaboutclinicaltrials
• Enrollmentcriteria
• ReturnofResults
• Privacyconcerns
• Lackofaccess
• Timeandresourceconstraintsforpatients
TheNeedforDiverseParticipation
• Racialandethnicminoritieshavebeenhistoricallyunder-representedinclinicaltrials
• Needrepresentationtostudytheeffectsofmedicalproductsinthepeoplewhowillultimatelyusethem
• Personsofdifferentages,races,andethnicitiescouldreactdifferentlytocertainmedicalproducts
• Tounderstandhealthdisparities- diseasesthatoccurmorefrequentlyorappeardifferentlyindiversepopulations
2012FDASafetyandInnovationAct(FDASIA)Section907ActionPlanPriorities&Strategies
DrugTrialsSnapshots:Summaries(2017-2019)
https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots
GuidanceDocumentsforIndustry
COVID-19InclusionofDiversePopulations
• FDAGuidanceforIndustryonDevelopmentandLicensureofVaccinestoPreventCOVID-19;June2020
§ “FDAencouragestheinclusionofdiversepopulationsinallphasesofvaccineclinicaldevelopment.Thisinclusionhelpstoensurethatvaccinesaresafeandeffectiveforeveryoneintheindicatedpopulations.”
§ “FDAstronglyencouragestheenrollmentofpopulationsmostaffectedbyCOVID-19,specificallyracialandethnicminorities.”
• FDAGuidanceforIndustryonCOVID-19:DevelopingDrugsandBiologicalProductsforTreatmentorPrevention;May2020
§ “Racialandethnicminoritypersonsshouldberepresentedinclinicaltrials.Sponsorsshouldensurethatclinicaltrialsitesincludegeographiclocationswithahigherconcentrationofracialandethnicminoritiestorecruitadiversestudypopulation.”
DiversityinClinicalTrialsInitiative
Developedanongoingmultimediacampaigntoraiseawarenessaroundtheimportanceofdiverserepresentation inclinicaltrialstoensuremedicalproductsaresafeandeffectiveforeveryone.
DiversityinClinicalTrialsCampaign
VideosNewsletters&
E-alerts
Webpage StakeholderCollaboration
Podcasts SocialMedia
CommunicationsToolkit Graphics
DiverseParticipationinClinicalTrialsVideosandPodcast
ClinicalTrialDiversityResources
ClinicalTrialDiversityResources
• DiversityinDeviceClinicalTrials
• DiabetesTreatmentandManagement
• HIV/AIDS
• AdditionalFactsheetsandInfographics
StrategiestoAdvanceDiverseParticipation
• Rememberthereisnotaonesizefitsallapproach
• Allactionsshouldbeginandendwiththepatientinmind
• Aplantoaddressinclusionshouldbedevelopedearlyonandshouldnotbeanafterthought
• Consistentandcontinuedcommunityengagement
• Engagepatientsintrialdesign,logistics,andrecruitmentandretentionpractices
• Sitelocationswheretherearemoreracialandethnicminorities
• Workforcediversity
• Engageproviders
• Culturalsensitivity,competency,andawareness
• Eliminatelanguagebarriers
• Organizationalgoalsthatsupportdiversity
TakeHomeMessage…
Askpatientstoparticipate!
ThankYou!
Followusat:@FDAHealthEquity
Emailusat:OMHHE@fda.hhs.gov
Visitusat:FDA.gov/HealthEquity
Joinwebinarsandstakeholdercalls
Sponsor PerspectiveSandra Amaro, Pfizer
Diversity in Clinical Trials, Operations Director
Cassandra Smith, JanssenDirector, Diversity and Inclusion in Clinical
Trials
Equity in Clinical Trials- Our Role as Sponsors • As a Sponsor we have a responsibility to ensure that our clinical trial participants reflect the racial and
ethnic diversity of the countries where we conduct clinical trials, and the epidemiology of the diseases we intend to treat or prevent
• In order to increase equity and address healthcare disparities Sponsors should…• Recognize the importance of cross collaboration with industry partners• LISTEN to the voice of our patients, advocacy partners and sites• Apply insights to our clinical development plans• Understand the barriers to entry that our underserved communities face and identify solutions to remove them• Ensure patient facing materials are easily understood and culturally sensitive• Invest in opportunities that will increase our diverse clinical workforce of the future• Partner with multicultural partners to foster community outreach, awareness and education• Be transparent with our site partners on our diverse recruitment goals, and what success looks like• LISTEN to what our sites need to ensure success
Equity in Clinical Trials- Your Role as a Site Partner
• Know the possibility for diverse recruitment• Does your site have all the tools necessary to support
diverse recruitment?• Does your site serve a diverse patient population?
• Request the support you need…early• Does your site need additional resources from the
Sponsor to reach the goal?
• Connect with the surrounding community• Does your site have relationships within the community?
Can you develop these relationships?
• Set up for success• Invite everyone to participate, as appropriate• Allow adequate time for explanation and consenting
DataEntry
As a Site Partner, you have the very important responsibility of providing high quality care and safety oversight to patients while compliantly conducting a clinical trial and
meeting administrative demands
Thank YouSandra Amaro – sandra.amaro@pfizer.com
RADM Richardae Araojo – richardae.araojo@fda.hhs.gov
Diana Foster – diana.foster@myscrs.org
Cassandra Smith – csmith52@its.jnj.com
Thankyou!
ForcontacthoursorCME’s,pleasecompletethesurveythatwillfollowthispresentation.
Ifyouhaveanyquestionsorissues,pleasecontactMichaelJayatmichael.jay@myscrs.org
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