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Race & Ethnic Demographics not reported in
over 50% of Randomized Clinical Trials for
Cardiovascular Disease
Newswise — A new study recently published
online by the American Heart Journal shows
that more than half of all randomized
clinical trials, or RCTs, for cardiovascular
disease are not reporting vital information
about the study populations race or
ethnicity.
NYU
School of Medicine researchers found that
out of the 156 cardiovascular disease RCTs
analyzed, only 35% of trials reported any
information on race or ethnicity between
1970 and 2006. From 2000 to 2006, 46% of
trials included that information.
“Over time, information on enrollment by
race and ethnic group has improved but
nevertheless, information on this important
demographic of patient enrollment is far
from ideal,” said Jeffrey S. Berger, MD, MS,
Director of Cardiovascular Thrombosis;
Assistant Professor of Medicine and Surgery
at The Leon H. Charney Division of
Cardiology at NYU School of Medicine.
“It is imperative that all studies provide
basic information including race and
ethnicity.
" Furthermore, we must have good
representation of different ethnic and
minority groups in RCTs to apply data
appropriately.”
According to study authors, diversity in
RCTs must be increased because
representation of minority ethnic groups
remains too low.
Study
findings showed that only 15% of trials had
sufficient diversity to even attempt
efficient analysis of results by race.
Researchers also cited that RCTs in the
United States were more likely to report
race than international trials with no U.S.
participants.
However,
enrollment information on race in the U.S.
was still less than one third of total
trials. RCTs funded by industry, federal
agency or a foundation all reported race
with similar frequency.
“Our study should have important
implications for future design and
publication of randomized clinical trials,”
said Dr. Berger.
“Race and ethnic demographics should be
strongly encouraged in future study
publications, along with the optimal
approach of mandating the reporting of race
and ethnic group in all RCTs including
cardiovascular disease trials.
"This
way we can successfully move forward,
enhancing the translation of study results
with better targeted therapies for the
diverse patient populations we treat.”
This study completed by NYU School of
Medicine, New York, NY; and Duke Clinical
Research Institute, Durham, NC was funded by
the American Heart Association and the Duke
Clinical Research Institute.
Link to study:
http://www.ahjonline.com/article/S0002-8703(09)00658-9/abstract
About NYU Langone Medical Center
One of the world’s leading academic medical
institutions for more than 168 years, NYU
Langone Medical Center is a leader in
patient care, physician education and
scientific research. It is comprised of NYU
School of Medicine, Rusk Institute for
Rehabilitation, NYU Hospital for Joint
Diseases, the NYU Cancer Institute and many
distinguished centers and programs. NYU
Langone Medical Center is internationally
renowned for excellence in areas such as
cardiovascular disease, pediatrics,
dermatology, neurosurgery, imaging, urology,
cancer care, rehabilitation, plastic
surgery, minimally invasive surgery,
transplant surgery, infertility, and women’s
health. For more information on NYU Langone
Medical Center, visit
www.nyumc.org
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