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Transcript of Project IMPACT IMPACT National Medical Association What African Americans Should Know About Clinical...
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!
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
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
Project Project IMPACTIMPACT
Today’s Standard Treatment Was Yesterday’s Clinical TrialToday’s Standard Treatment Was Yesterday’s Clinical Trial
Project Project IMPACTIMPACT
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
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
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
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!
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!
Project Project IMPACTIMPACT
African American’s Perceptions of Clinical TrialsAfrican American’s Perceptions of Clinical Trials
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”
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
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
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
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
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
Project Project IMPACTIMPACT
Evaluating Whether or Not to ParticipateEvaluating Whether or Not to Participate
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?
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
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
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
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
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
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
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 !!