More than half RCTs do not report vital information about study populations race, says study

NYU Langone Medical Center / New York University School of MedicineOct 15 2009

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."