MHRP EngageProject2006 04 26

What Communities of Color Should Know About Clinical TrialsUniversity of Michigan Health Systems (UMHS) – Minority Health Research Program (MHRP), 2006 : 

What Communities of Color Should Know About Clinical Trials University of Michigan Health Systems (UMHS) – Minority Health Research Program (MHRP), 2006

Information Presented by:: 

Information Presented by: Minority Health Research Program (MHRP) a collaborative partnership composed of: • Diversity & Career Development Office – David Gordon, MD, Tahnee C. H. Prokopow, MPH, Kofi K. Gyan, MPH, MPA • General Clinical Research Center – John Wiley, MD, Cynthia Bower, RN, MS, Nancy Lowenbergh, BSN, RN • Program for Multicultural Health – Gloria Edwards, Ph. D. • Comprehensive Cancer Center – Natasha Blakeney, MPH • Women’s Health Program – Angela Johnson, MA • Ypsilanti Health Center – Terence Joiner, MD • Local Ann Arbor and Ypsilanti Communities

Ten Leading Causes of Death: 

Ten Leading Causes of Death Heart Disease Cancer Stroke Accident Diabetes Homicide HIV/AIDS Chronic Pulmonary Disease Nephritic Syndrome and Nephritis Septicemia Source: National Center for Health Statistics 2004

Our Health Status: 

Our Health Status • Life expectancy for African American men is almost 8 years less than for white men • African Americans w/ diabetes get leg amputations ~2.3 times more frequently than among whites • Glaucoma causes blindness in African Americans ~7 times that of whites • Latinos have higher mortality rates than whites for diabetes, renal failure, homicide, and pregnancy complications Source: National Center for Health Statistics 2004

Slide5: 

Our Health Status (Con’t) • African American men are 40% more likely to have heart disease • People of color have a 200 – 500% higher prevalence of type II 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 African Americans • African American women are 28% greater death rate from breast cancer Source: National Center for Health Statistics 2004

What is a Clinical Trial?: 

What is 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 Source: ClinicalTrials.gov

Stages in the Development of Medicines: 

Stages in the Development of Medicines Laboratory Research Animal Testing Clinical Trials in Humans Source:ClinicalTrials.gov

The Process: 

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 Source: ClinicalTrials.gov

Terminology!: 

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 Source: ClinicalTrials.gov

Who is Watching Out for Your Interest!: 

Who is Watching Out for Your Interest! • UMHS – General Clinical Research Center • UMHS – Institution Review Board • The Physician (Principal Investigator) • The National Institutes of Health • You - your knowledge of the process

Communities of Color’s Perceptions of Clinical Trials: 

Communities of Color’s Perceptions of Clinical Trials Slide from NMA Project IMPACT

The Past: 

The Past • Treatment of minority populations throughout US history • “Night Doctors,” Fredericksburg, VA 1886 • Tuskegee Syphilis Study, 1932 – 1972 • Birth Control Pill Testing in Puerto Rico, 1960’s • Pima Indians and NIH Diabetes Study in Arizona, 1965 – 1995 & 1996 – 1999

Why Don’t We Participate !: 

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 Source: NMA Project IMPACT

Why You Should Care!: 

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 Source: NMA Project IMPACT

Benefits: 

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 Source: NMA Project IMPACT

Possible Risks & Inconveniences: 

Possible Risks & Inconveniences • Potential side effects to medication • Placebo treatment • May not work for you • May have to stop taking other medications • Time Commitment • Transportation • Unknown risks Source: NMA Project IMPACT

Questions: Ask & Get Answered: 

Questions: Ask & Get 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? Source: UNC/CDC “Project LinCS” pamphlet.

Questions: Ask & Get Answered (Con’t): 

Questions: Ask & Get Answered (Con’t) • 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? Source: UNC/CDC “Project LinCS” pamphlet.

Your Decision & Your Rights: 

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 Source: NMA Project IMPACT

Your Rights & Protections: 

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 Source: NMA Project IMPACT

Finding Clinical Trials &Information: 

Finding Clinical Trials & Information • Minority Health Research Program (MHRP) (734) 647-1626 • General Clinical Research Center (GCRC) (734) 544-3204 • UMHS Website http://www.med.umich.edu/engage/ • Your Primary Care Physician (PCP)

Federal Government: Minority Health and Health Statistics Web Sites: 

Federal Government: Minority Health and Health Statistics Web Sites • http://www.ahrq.gov/consumer/espanoix.htm • http://www.healthgap.omhrc.gov/ • http://www.cdc.gov/nchs/otheract/grants/minpop.htm • http://grants.nih.grants/funding/dwomen_min/women_min.htm • http://raceandhealth.hhs.gov/ • http://www.cdc.gov/hiv/pubs/brochure/unc3bro.pdf • http://gucchd.georgetown.edu/nccc/