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Cardiology |
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| 14 Oct 2009 | Viewed: 31 | |
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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 Duke Clinical Research Institute.
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| News Source: medical news today |
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