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

2. Project IMPACT IMPACT Top Ten Deadly Killers 1) Heart Disease 2) Cancer 2) Cancer 3) Stroke 3) Stroke 4) Accident 4) Accident 5) Diabetes 5) Diabetes 6) Homicide 6) Homicide 7) Pneumonia and Influenza 7) Pneumonia and Influenza 8) Chronic Pulmonary Diseases 8) Chronic Pulmonary Diseases 9) HIV 9) HIV 10)Perinatal

3. Project IMPACT IMPACT African American men – 40 % more likely to have heart disease People of color have a 200-500% higher prevalence of type 2 diabetes People of color have a 200-500% higher prevalence of type 2 diabetes Obesity and obesity related diseases are Obesity and obesity related diseases are 50-100% 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 Black African American women – 28 % greater death rate from breast cancer African American women – 28 % greater death rate from breast cancer Our Health Status

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

5. Project What’s a Clinical Trial? Clinical trials are carefully designed medical research studies conducted with people that: test promising diagnostic, test promising diagnostic, treatment and prevention methods treatment and prevention methods attempt to answer scientific questions attempt to answer scientific questions

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

7. Project IMPACT IMPACT The Process Phase I - First studies in people to test safety Phase I - First studies in people to test safety Phase II - Is it effective and how much should be given 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 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 Phase IV - Usually compares the new drug with other drugs already on the market

8. Project IMPACT IMPACT Protocol - Study action plan Protocol - Study action plan Placebo - Look-alike pill that contains no active ingredient 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 Informed Consent - The process by which an individual learns key facts about a clinical trial before he/she decides to participate or not Terminology!

9. Project IMPACT IMPACT US Department of Health and Human Services The National Institutes of Health The National Institutes of Health The Food and Drug Administration The Food and Drug Administration The Institutional Review Board The Institutional Review Board The Physician/ Investigator The Physician/ Investigator You - your knowledge of the process You - your knowledge of the process Who is Watching Out for Your Interest!

10. Project IMPACT IMPACT African American’s Perceptions of Clinical Trials

11. Project IMPACT IMPACT T he Past Pre - and post - Civil War Medical Experimentation Pre - and post - Civil War Medical Experimentation Tuskegee Syphilis Experiments Tuskegee Syphilis Experiments “Student or Night Doctors” “Student or Night Doctors”

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

13. Project IMPACT IMPACT Why Don’t We Participate ! Lack of Awareness No Access to Healthcare No Access to Healthcare The Doctor Didn’t Recommend it The Doctor Didn’t Recommend it Fear and/or Distrust Fear and/or Distrust Cultural Beliefs or Myths Cultural Beliefs or Myths Racial and Ethnic Discrimination Racial and Ethnic Discrimination

14. Project IMPACT IMPACT Why You Should Care! Few African American patients and physicians participate in clinical trials Most drugs are approved without adequate African American participation Most drugs are approved without adequate African American participation Targeted therapies based on genetics Targeted therapies based on genetics Drugs approved based on foreign data Drugs approved based on foreign data Expectation that approved drugs will Expectation that approved drugs will work for us - which isn’t always true

15. Project IMPACT IMPACT Better targeted medicines Better targeted medicines Access to, and experience with the newest treatments before they are available to others Access to, and experience with the newest treatments before they are available to others Your health is watched very carefully Your health is watched very carefully Most study treatment are at no cost Most study treatment are at no cost You will be helping others You will be helping others Benefits

16. Project IMPACT IMPACT Possible Risks & Inconveniences Potential side effects to medication Potential side effects to medication Placebo treatment Placebo treatment May not work for you May not work for you May have to stop taking other medications May have to stop taking other medications Time Time Transportation Transportation Unknown risks Unknown risks

17. Project IMPACT IMPACT Evaluating Whether or Not to Participate

18. Project IMPACT IMPACT Questions: 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 conducted? Where is the trial being 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?

19. Project IMPACT IMPACT How will I be protected from harm? How will I be protected from harm? Do I have to pay for any part of the trial? Do I have to pay for any part of the trial? Who can I contact if there are any Who can I contact if there are any 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 & Answered

20. Project IMPACT IMPACT Your Decision & Your Rights yours 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

21. Project IMPACT 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 Signing the informed consent form does not mean you must stay in the study You have the right to leave the study You have the right to leave the study at any time

22. Project IMPACT IMPACT Finding Clinical Trials & Information Your healthcare provider National Medical Association 202/347-1895 or www.NMAnet.org The newspaper, radio, television The newspaper, radio, television Cancer Information Service 1-800-4CANCER The Internet The Internet

23. Project IMPACT IMPACT Internet Sources FDA/ Office of Special Health Issues FDA/ Office of Special Health Issueshttp://www.fda.gov/oashi/home.html National Library of Medicine National Library of Medicinehttp://www.clinicaltrials.gov NCI/CancerNet NCI/CancerNethttp://cancer.gov/clinicaltrials/ Centerwatch Clinical Trials Centerwatch Clinical Trialshttp://www.centerwatch.com

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

25. Project Bei ng an Educated Consumer is Your Best Protection! The Choice is Yours !