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