Why African Americans Must Understand and Participate in Clinical Trials and Vaccines Virginia A. Caine, M.D. Associate Professor of Medicine Division of Infectious Diseases Indiana University School of Medicine Director, Marion County Public Health Department Indianapolis, Indiana

What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or group of people.

Why are Clinical Trials Needed?  Health care is increasingly reliant on evidence-based medicine.  Significant burden on clinical research to provide the knowledge upon which such evidence is based.  Does a treatment work? Does it work better than other treatments? Does it have any side effects?  Clinical trials are designed to answer these questions and improve health and quality of life for patients.

Clinical Research  Safety oversight is a major, multilayered challenge for modern clinical research.  Institutional Review Boards (IRBs) has the responsibility to assure that steps are taken to safeguard the rights and welfare of those who agree to be research subjects.  IRBs exist on the local level that include non-scientists, as well as scientists not connected to the research.

Clinical Research  In a recent poll of 6,000 cancer patients, 84% were unaware at the time of their diagnosis, that participation in a clinical trial was an option.  A Study reveals that nearly half of all patients involved in clinical trials, learn from their physicians, 35% from media, 9 percent from the Internet, and 8% from family or friends.

Clinical Research  Most experts believe that there should be a % patient participation rate in clinical trials.  In contrast, 80-90% of cancer-afflicted children are enrolled in clinical trials.

Progress in the Last Half-Century as a Result of Clinical Trials  Fifty years ago, many treatments did not exist  From , the age-adjusted death rate in the US for coronary heart disease was cut in half  A randomized trial of the Salk polio vaccine in over 600,000 school children has nearly eradicated polio in the U.S.

measles

Measles can be serious  Ear infections occur in about one out of every 10 children with measles and can result in permanent hearing loss.  About 1 in 4 people in the U.S. who get measles will be hospitalized.  About 1 child out of every 1,000 who get measles will develop encephalitis (swelling of the brain) that can lead to convulsions and can leave the child deaf or with intellectual disability.  As many as one out of every 20 children with measles gets pneumonia the most common cause of death from measles in young children.

Measles  PREVENTION  MMR vaccine  Safe and effective  First dose given at months; booster dose at ages 4-6 years, required before entry to kindergarten  Approximately 93% immunity following one dose of vaccine, increases to 99% immunity following second dose  Unvaccinated persons or persons without evidence of immunity participating in higher education should receive two doses of MMR vaccine at least 28 days apart  Unvaccinated adults born during or later than 1957 should receive at least one dose of MMR  Persons born before 1957 can be considered to have immunity

Progress in the Last Half-Century (continued)  Measles was nearly eliminated by a vaccine tested in clinical trials.  Fatal outcomes and brain infection from measles leading to permanent brain damage were uncommon but devastating complications.

Busted!

Tuberculosis Prevention  Landmark trial of tuberculosis prevention in a remote community of 7,333 Alaskan natives conducted from by the US Public Health Service resulted in 86 percent community participation  Six years of follow-up showed an average reduction of 60 percent in new, active cases of tuberculosis.

Reported TB Cases* United States, 1982–2008 Year No. of Cases *Updated as of May 20, 2009.

HIV in the United States  More than 1.1 million people in the United States are living with HIV infection, and almost 1 in 6 (15.8%) are unaware of their infection  Gay, bisexual, and other men who have sex with men (MSM), particularly young Black/African American MSM, are most seriously affected by HIV  By race, Blacks/African Americans face the most severe burden of HIV Source: Centers for Disease Control and Prevention (CDC)

Estimated New HIV Infections in the United States, 2010, for the Most Affected Subpopulations

Antiretroviral Agents 2007 Nucleoside analogues zidovudine (AZT, ZDV) didanosine (ddI) zalcitabine (ddC) stavudine (D4T) lamivudine (3TC) abacavir (ABC) emtricitabine (FTC) tenofovir (TDF) Non-nucleoside analogues nevirapine (NVP) delavirdine (DLV) efavirenz (EFV)

Antiretroviral Agents 2007 Protease inhibitors saquinavir (SQV) ritonavir (RIT) indinavir (IDV) nelfinavir (NFV) amprenavir (APV) fosamprenavir (FOS) lopinavir (LPV) atazanavir (ATZ) tipranavir (TPV) darunavir (DRV) Fusion inhibitors T20 CCR5 inhibitors maraviroc Integrase inhibitors raltegravir

Why are Clinical Trials Important?  National Heart, Lungs and Blood Institute tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women.  The study found that HT increased the risk of heart disease, risk of stroke and blood clots.  In women who took a combination of estrogen and progestin, the risk of breast cancer also increased.

Science and Society  When patients get involved, science succeeds and we all benefit.  The good news is when patients participate they respond favorably to the experience.  Clinical research holds great promise and tremendous opportunities.