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National Medical Association

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

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National Medical Association

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

  2. 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 Top Ten Deadly Killers

  3. 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 death rate from breast cancer

  4. Today’s Standard Treatment Was Yesterday’s Clinical Trial Project IMPACT

  5. 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

  6. Stages in the Development of Medicines Laboratory Research Animal Testing Clinical Trials in Humans

  7. 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 with other drugs already on the market

  8. 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

  9. 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

  10. African American’s Perceptions of Clinical Trials

  11. The Past • Pre - and post - Civil War Medical Experimentation • Tuskegee Syphilis Experiments • “Student or Night Doctors”

  12. The Tuskegee Experience •1930s US Public Health Service Study • African American Males with Untreated Syphilis • Patients Were Denied Treatment for 40 Years

  13. 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

  14. 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

  15. 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

  16. 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

  17. Evaluating Whether or Not to Participate

  18. 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?

  19. 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?

  20. Your Decision & Your Rights •The decision to participate isyours •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

  21. 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

  22. Finding Clinical Trials &Information •Your healthcare provider •National Medical Association 202/347-1895 or www.NMAnet.org •The newspaper, radio, television •Cancer Information Service1-800-4CANCER • The Internet

  23. 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

  24. An Educated Consumer . . . Project IMPACT •Researches health care options • Learns about a specific trial’s risks, costs, and benefits • Asks their health care provider for additional information

  25. Being an Educated Consumer is Your Best Protection! The Choice is Yours !

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