Transcript Virginia A. Caine MD - Healthy Churches 2020

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
10-15 % 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 1980-2000, 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 12-15 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 1957-59 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
No. of Cases
28,000
26,000
24,000
22,000
20,000
18,000
16,000
14,000
12,000
10,000
1984
1987
1990
1993
Year
*Updated as of May 20, 2009.
1996
1999
2002
2005
2008
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.