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Project Project IMPACT IMPACT National Medical Association What African What African Americans Americans Should Know Should Know About About Clinical Trials Clinical Trials You’ve Got the Power!
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National Medical Association

Feb 05, 2016

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What African Americans Should Know About Clinical Trials. You’ve Got the Power!. National Medical Association. 1) Heart Disease 2) Cancer 3) Stroke 4) Accident 5) Diabetes 6) Homicide 7) Pneumonia and Influenza 8) Chronic Pulmonary Diseases 9) HIV - PowerPoint PPT Presentation
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Page 1: National  Medical  Association

Project Project IMPACTIMPACT

National Medical Association

What African What African Americans Americans Should Know Should Know About About Clinical TrialsClinical Trials

You’ve Got the Power!You’ve Got the Power!

Page 2: National  Medical  Association

Project Project IMPACTIMPACT

Top Ten Deadly KillersTop Ten Deadly Killers

1)1) Heart DiseaseHeart Disease 2)2) CancerCancer 3)3) StrokeStroke 4)4) Accident Accident 5)5) DiabetesDiabetes 6)6) Homicide Homicide 7)7) Pneumonia and InfluenzaPneumonia and Influenza 8)8) Chronic Pulmonary DiseasesChronic Pulmonary Diseases 9)9) HIVHIV10)10)PerinatalPerinatal

Page 3: National  Medical  Association

Project Project IMPACTIMPACT

•• African American men – 40 % more likely to African American men – 40 % more likely to have heart diseasehave heart disease

•• People of color have a 200-500% higher People of color have a 200-500% higher prevalence of type 2 diabetesprevalence of type 2 diabetes

•• Obesity and obesity related diseases are Obesity and obesity related diseases are 50-100% higher in African Americans50-100% higher in African Americans

•• Nearly 80% of women with HIV/AIDS are Nearly 80% of women with HIV/AIDS are from minority groups, majority are Blackfrom minority groups, majority are Black

•• African American women – 28 % greaterAfrican American women – 28 % greater death rate from breast cancer death rate from breast cancer

Our Health StatusOur Health StatusOur Health StatusOur Health Status

Page 4: National  Medical  Association

Project Project IMPACTIMPACT

Today’s Standard Treatment Was Yesterday’s Clinical TrialToday’s Standard Treatment Was Yesterday’s Clinical Trial

Project Project IMPACTIMPACT

Page 5: National  Medical  Association

Project Project IMPACTIMPACT

What’s a Clinical Trial?What’s a Clinical Trial?

Clinical trials are carefully designed Clinical trials are carefully designed

medical research studies conducted medical research studies conducted

withwith people that: people that:

• • test promising diagnostic,test promising diagnostic,

treatment and prevention treatment and prevention

methodsmethods

•• attempt to answer scientific attempt to answer scientific

questionsquestions

Page 6: National  Medical  Association

Project Project IMPACTIMPACT

Laboratory ResearchLaboratory Research

Stages in the Development of MedicinesStages in the Development of Medicines

Animal TestingAnimal Testing

Clinical Trials in HumansClinical Trials in Humans

Page 7: National  Medical  Association

Project Project IMPACTIMPACT

The ProcessThe Process

• • Phase IPhase I - First studies in people to test - First studies in people to test safety safety

• • Phase IIPhase II - Is it effective and how much - Is it effective and how much should be givenshould be given

• • Phase IIIPhase III - Testing on more people to learn - Testing on more people to learn more about the drug’s effectiveness, benefits more about the drug’s effectiveness, benefits and range of possible adverse reactionsand range of possible adverse reactions

• • Phase IVPhase IV - Usually compares the new drug - Usually compares the new drug with other drugs already on the marketwith other drugs already on the market

Page 8: National  Medical  Association

Project Project IMPACTIMPACT

• • ProtocolProtocol - Study action plan - Study action plan

• • PlaceboPlacebo - Look-alike pill that contains - Look-alike pill that contains no active ingredientno active ingredient

• • Informed ConsentInformed Consent - The process by - The process by which an individual learns key facts which an individual learns key facts about a clinical trial before he/she about a clinical trial before he/she decides to participate or notdecides to participate or not

Terminology!Terminology!

Page 9: National  Medical  Association

Project Project IMPACTIMPACT

•• US Department of Health and Human US Department of Health and Human

ServicesServices

•• The National Institutes of HealthThe National Institutes of Health

•• The Food and Drug Administration The Food and Drug Administration

• • The Institutional Review BoardThe Institutional Review Board

• • The Physician/ InvestigatorThe Physician/ Investigator

• • You - your knowledge of the processYou - your knowledge of the process

Who is Watching Out for Your Interest!Who is Watching Out for Your Interest!

Page 10: National  Medical  Association

Project Project IMPACTIMPACT

African American’s Perceptions of Clinical TrialsAfrican American’s Perceptions of Clinical Trials

Page 11: National  Medical  Association

Project Project IMPACTIMPACT

The PastThe Past

•• Pre - and post - Civil War Pre - and post - Civil War Medical ExperimentationMedical Experimentation

•• Tuskegee Syphilis Tuskegee Syphilis ExperimentsExperiments

•• “ “Student or Night Doctors”Student or Night Doctors”

Page 12: National  Medical  Association

Project Project IMPACTIMPACT

The Tuskegee ExperienceThe Tuskegee Experience

•• 1930s US Public Health Service Study1930s US Public Health Service Study

• • African American Males with Untreated African American Males with Untreated SyphilisSyphilis

•• Patients Were Denied Treatment for Patients Were Denied Treatment for 40 Years40 Years

Page 13: National  Medical  Association

Project Project IMPACTIMPACT

Why Don’t We Participate !Why Don’t We Participate !

•• Lack of AwarenessLack of Awareness

•• No Access to HealthcareNo Access to Healthcare

• • The Doctor Didn’t The Doctor Didn’t Recommend itRecommend it

•• Fear and/or DistrustFear and/or Distrust

• • Cultural Beliefs or MythsCultural Beliefs or Myths

•• Racial and Ethnic Racial and Ethnic DiscriminationDiscrimination

Page 14: National  Medical  Association

Project Project IMPACTIMPACT

Why You Should Care!Why You Should Care!

•• Few African American patients and Few African American patients and physicians participate in clinical trialsphysicians participate in clinical trials

•• Most drugs are approved without Most drugs are approved without adequate adequate African American African American participationparticipation

• • Targeted therapies based on geneticsTargeted therapies based on genetics

• • Drugs approved based on foreign dataDrugs approved based on foreign data

• • Expectation that approved drugs will Expectation that approved drugs will work for us - which isn’t always truework for us - which isn’t always true

Page 15: National  Medical  Association

Project Project IMPACTIMPACT

•• Better targeted medicinesBetter targeted medicines

•• Access to, and experience with the Access to, and experience with the newest treatments before they are newest treatments before they are available to othersavailable to others

• • Your health is watched very carefullyYour health is watched very carefully

• • Most study treatment are at no costMost study treatment are at no cost

•• You will be helping othersYou will be helping others

BenefitsBenefits

Page 16: National  Medical  Association

Project Project IMPACTIMPACT

Possible Risks & InconveniencesPossible Risks & Inconveniences

•• Potential side effects to medicationPotential side effects to medication

• • Placebo treatmentPlacebo treatment

•• May not work for youMay not work for you

• • May have to stop taking other May have to stop taking other medicationsmedications

•• TimeTime

•• TransportationTransportation

•• Unknown risksUnknown risks

Page 17: National  Medical  Association

Project Project IMPACTIMPACT

Evaluating Whether or Not to ParticipateEvaluating Whether or Not to Participate

Page 18: National  Medical  Association

Project Project IMPACTIMPACT

Questions: Ask & AnsweredQuestions: Ask & Answered

•• What is the study about?What is the study about?

•• Who put the study together?Who put the study together?

•• Where is the trial being Where is the trial being conducted?conducted?

• • What will I get out of this study?What will I get out of this study?

•• What are the risks to me?What are the risks to me?

•• How long will the study last?How long will the study last?

•• What tests are involved? What tests are involved?

Page 19: National  Medical  Association

Project Project IMPACTIMPACT

•• How will I be protected from harm?How will I be protected from harm?

•• Do I have to pay for any part of the Do I have to pay for any part of the trial?trial?

•• Who can I contact if there are anyWho can I contact if there are any

problems or to ask questions?problems or to ask questions?

• • What do I have to do in this study?What do I have to do in this study?

•• What are my other options?What are my other options?

Questions: Ask & AnsweredQuestions: Ask & Answered

Page 20: National  Medical  Association

Project Project IMPACTIMPACT

Your Decision & Your RightsYour Decision & Your Rights

•• The decision to participate is yoursyours

•• Informed Consent is more than a signature –it is a process that your health care provider should walk you through

–– You must be given all the facts about a study before you decide to participate

–– This includes details about the treatments and test(s) you may receive and the benefits and risks

–– Your rights should be fully explained

Page 21: National  Medical  Association

Project Project IMPACTIMPACT

Your Rights & ProtectionsYour Rights & Protections

•• You must sign an informed consent form You must sign an informed consent form (only sign if you completely understand (only sign if you completely understand everything)everything)

• • Signing the informed consent form does Signing the informed consent form does not mean you not mean you must must stay in the studystay in the study

•• You have the right to leave the study You have the right to leave the study at any timeat any time

Page 22: National  Medical  Association

Project Project IMPACTIMPACT

Finding Clinical Trials &InformationFinding Clinical Trials &Information

•• Your healthcare providerYour healthcare provider

•• National Medical Association National Medical Association 202/347-1895 or 202/347-1895 or

www.NMAnet.orgwww.NMAnet.org

•• The newspaper, radio, The newspaper, radio, televisiontelevision

•• Cancer Information ServiceCancer Information Service 1-800-4CANCER1-800-4CANCER

• • The InternetThe Internet

Page 23: National  Medical  Association

Project Project IMPACTIMPACT

Internet SourcesInternet Sources

•• FDA/ Office of Special Health IssuesFDA/ Office of Special Health Issueshttp://www.fda.gov/oashi/home.htmlhttp://www.fda.gov/oashi/home.html

•• National Library of MedicineNational Library of Medicinehttp://www.clinicaltrials.govhttp://www.clinicaltrials.gov

• • NCI/CancerNetNCI/CancerNethttp://cancer.gov/clinicaltrials/http://cancer.gov/clinicaltrials/

•• Centerwatch Clinical TrialsCenterwatch Clinical Trialshttp://www.centerwatch.comhttp://www.centerwatch.com

Page 24: National  Medical  Association

Project Project IMPACTIMPACT

An Educated Consumer . . .An Educated Consumer . . .

•• Researches health care optionsResearches health care options

•• Learns about a specific trial’s Learns about a specific trial’s risks, costs, and benefitsrisks, costs, and benefits

• • Asks their health care provider Asks their health care provider for additional informationfor additional information

Project Project IMPACTIMPACT

Page 25: National  Medical  Association

Project Project IMPACTIMPACT

Being an Educated Consumer is Your Best Protection!Being an Educated Consumer is Your Best Protection!

The The Choice is Choice is Yours Yours !!