Transcript You`ve Got the Power! - Project I.M.P.A.C.T.

You’ve Got the Power!
What African
Americans
Should Know
About
Clinical Trials
National
Medical
Association
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IMPACT
Top Ten Deadly Killers
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Heart Disease
Cancer
Stroke
Accident
Diabetes
Homicide
Pneumonia and Influenza
Chronic Pulmonary Diseases
HIV
Perinatal
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Our Health Status
• African American men – 40 % more likely
to have heart disease
• People of color have a 200-500% higher
prevalence of type 2 diabetes
• Obesity and obesity related diseases are
50-100% higher in African Americans
• Nearly 80% of women with HIV/AIDS are
from minority groups, majority are Black
• African American women – 28 % greater
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death rate from breast cancer
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Today’s Standard Treatment Was
Yesterday’s Clinical Trial
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What’s a Clinical Trial?
Clinical trials are carefully designed
medical research studies conducted
with people that:
• test promising diagnostic,
treatment and prevention
methods
• attempt to answer scientific
questions
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Stages in the Development of
Medicines
Laboratory Research
Animal Testing
Clinical Trials in Humans
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The Process
• Phase I - First studies in people to test
safety
• Phase II - Is it effective and how much
should be given
• Phase III - Testing on more people to learn
more about the drug’s effectiveness,
benefits and range of possible adverse
reactions
• Phase IV - Usually compares the new
drug
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with other drugs already on the market
Terminology!
• Protocol - Study action plan
• Placebo - Look-alike pill that contains
no active ingredient
• Informed Consent - The process by
which an individual learns key facts
about a clinical trial before he/she
decides to participate or not
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Who is Watching Out for
Your Interest!
• US Department of Health and Human
Services
• The National Institutes of Health
• The Food and Drug Administration
• The Institutional Review Board
• The Physician/ Investigator
• You - your knowledge of the process
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African American’s
Perceptions of Clinical Trials
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The Past
• Pre - and post - Civil War
Medical Experimentation
• Tuskegee Syphilis Experiments
• “Student or Night Doctors”
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The Tuskegee Experience
• 1930s US Public Health Service Study
• African American Males with Untreated
Syphilis
• Patients Were Denied Treatment for
40 Years
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Why Don’t We Participate !
• Lack of Awareness
• No Access to Healthcare
• The Doctor Didn’t Recommend
it
• Fear and/or Distrust
• Cultural Beliefs or Myths
• Racial and Ethnic
Discrimination
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Why You Should Care!
• Few African American patients and
physicians participate in clinical trials
• Most drugs are approved without
adequate African American participation
• Targeted therapies based on genetics
• Drugs approved based on foreign data
• Expectation that approved drugs will
work for us - which isn’t always true
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Benefits
• Better targeted medicines
• Access to, and experience with the
newest treatments before they are
available to others
• Your health is watched very carefully
• Most study treatment are at no cost
• You will be helping others
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Possible Risks &
Inconveniences
• Potential side effects to medication
• Placebo treatment
• May not work for you
• May have to stop taking other
medications
• Time
• Transportation
• Unknown risks
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Evaluating Whether or Not to
Participate
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Questions: Ask & Answered
• What is the study about?
• Who put the study together?
• Where is the trial being conducted?
• What will I get out of this study?
• What are the risks to me?
• How long will the study last?
• What tests are involved?
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Questions: Ask & Answered
• How will I be protected from harm?
• Do I have to pay for any part of the
trial?
• Who can I contact if there are any
problems or to ask questions?
• What do I have to do in this study?
• What are my other options?
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Your Decision & Your Rights
• The decision to participate is yours
• 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
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– Your rights should be fully explained IMPACT
Your Rights & Protections
• You must sign an informed consent form
(only sign if you completely understand
everything)
• Signing the informed consent form does
not mean you must stay in the study
• You have the right to leave the study
at any time
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Finding Clinical Trials &
Information
• Your healthcare provider
• National Medical Association
202/347-1895 or www.NMAnet.org
• The newspaper, radio, television
• Cancer Information Service
1-800-4CANCER
• The Internet
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Internet Sources
• FDA/ Office of Special Health Issues
http://www.fda.gov/oashi/home.html
• National Library of Medicine
http://www.clinicaltrials.gov
• NCI/CancerNet
http://cancer.gov/clinicaltrials/
• Centerwatch Clinical Trials
http://www.centerwatch.com
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An Educated Consumer . . .
• Researches health care options
• Learns about a specific trial’s risks,
costs, and benefits
• Asks their health care provider for
additional information
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Being an Educated Consumer
is Your Best Protection!
The Choice
is Yours !
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