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

Top Ten Deadly Killers 1) Heart Disease 2) Cancer 3) Stroke 4) Accidents 5) Diabetes 6) Homicide 7) Kidney Disease 8) Chronic Pulmonary Diseases 9) HIV/AIDS 10) Infection

Our Health Status • African Americans – 40 % more likely to have high blood pressure • Approximately 15% of African Americans over the age of 20 have diabetes • 4 in 5 African American women are obese or overweight • African Americans are the racial/ethnic group most affected by HIV • Breast Cancer is the 2nd leading cause of cancer deaths for African American women Four in five African-American women are obese or overweight, according to the U.S. Office of Minority Health, and carrying those excess pounds can spike the risk for several conditions including heart disease, Type 2 diabetes, high blood pressure and stroke. (Kaiser Health News 12/11) African Americans are twice as likely to be diagnosed with diabetes as non-Hispanic whites. In addition, they are more likely to suffer complications from diabetes, such as end-stage renal disease and lower extremity amputations. Although African Americans have the same or lower rate of high cholesterol as their non-Hispanic white counterparts, they are more likely to have high blood pressure. African American adults are twice as likely than non-Hispanic white adults to have been diagnosed with diabetes by a physician. In 2006, African American men were 2.2 times as likely to start treatment for end-stage renal disease related to diabetes, as compared to non-Hispanic white men. In 2006, diabetic African Americans were 1.5 times as likely as diabetic Whites to be hospitalized. In 2006, African Americans were 2.3 times as likely as non-Hispanic Whites to die from diabetes. (Office of Minority Health) African Americans are the racial/ethnic group most affected by HIV. In 2009, African Americans comprised 14% of the US population but accounted for 44% of all new HIV infections. Young African American gay and bisexual men are especially at risk of HIV infection. (CDC)

Today’s Standard of Care was Probably Yesterday’s Clinical Trial Project IMPACT

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

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

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

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

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

African American’s Perceptions of Clinical Trials

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

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

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

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

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 costs • You will be helping others

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

Evaluating Whether or Not to Participate

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?

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?

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 – Your rights should be fully explained

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

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

Internet Sources • Food and Drug Administration http://www.fda.gov • National Library of Medicine http://www.clinicaltrials.gov • Education Network to Advance Clinical Trials www.enacct.org/ • NCI/CancerNet http://cancer.gov/clinicaltrials/ • Center for Information and Study on Clinical Research Participation http://www.ciscrp.org/

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 Project IMPACT

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