What African Americans Should Know About Clinical Trials

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• What African Americans Should Know About
  Clinical Trials

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• 1) Heart Disease
• 2) Cancer
• 3) Stroke
• 4) Accident
• 5) Diabetes
• 6) Homicide
• 7) Pneumonia and Influenza
• 8) Chronic Pulmonary Diseases
• 9) HIV
• 10) Perinatal

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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 death rate from breast
cancer
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• 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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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 drugs
effectiveness, benefits and range of possible
adverse reactions Phase IV - Usually compares
the new drug with other drugs already on the
market
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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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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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Pre - and post - Civil War Medical
Experimentation Tuskegee Syphilis
Experiments Student or Night Doctors
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1930s US Public Health Service Study
African American Males with Untreated Syphilis
Patients Were Denied Treatment for 40 Years
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Lack of Awareness No Access to
Healthcare The Doctor Didnt Recommend it
Fear and/or Distrust Cultural Beliefs or
Myths Racial and Ethnic Discrimination
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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 isnt always true
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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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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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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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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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• 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
• Your rights should be fully explained

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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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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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FDA/ Office of Special Health
Issues http//www.fda.gov/oashi/home.html
National Library of Medicine http//www.clinical
trials.gov NCI/CancerNet http//cancer.gov/c
linicaltrials/ Centerwatch Clinical
Trials http//www.centerwatch.com
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Researches health care options Learns about a
specific trials 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 !