Less Than a Quarter of Pulmonary Clinical Trials Report Ethnicity

When the Food and Drug Administration Amendment Act (FDAAA) went into effect in 2007, summaries from clinical trials were required to be posted to ClinicalTrials.gov. While demographics are required in data, race/ethnicity are not, and an alarming amount of pulmonary studies did not report the optional information.

L. Ebony Boulware, MD, from Duke University School of Medicine, and colleagues analyzed the summaries to discover just how many lung-related clinical trials didn’t look at race/ethnicity. A poster session about the analysis is set to be revealed at CHEST 2015 in Montréal, Canada.

“Tracking minority representation in clinical trials is important to help characterize heterogeneity of treatment effects, but it has been difficult due to variable reporting in peer-reviewed literature,” the researchers explained.

The team gathered information from 1,450 highly likely applicable clinical trials (HLACTs) which consisted of phase II, III, IV, studies and FDA-regulated drugs, devices, and biologics from 2008 to 2012. They broke down the HLACTs by pulmonary disease, such as asthma, COPD, neoplasm, etc., and continued to track race/ethnicity in the summaries through September 2013. Study type, phase, year of completion, and disease type, as well as funding source, were all taken into consideration when analyzing the data.

The findings revealed that 55.1% (619 HLACTs) failed to report race/ethnicity by September 2013. Only 23.1% (143 HLACTs) collected that information from its participants. When compared to drug trials, biologic trials were significantly less likely to have that information. Furthermore, recent studies were more likely to have data on race/ethnicity (2013 versus 2009).

“Reporting was particularly low among biologic trials, while trials completed recently and studying asthma and COPD were more likely to report race or ethnicity,” the team observed.

The authors advise that reporting filling in this gap could help uncover specific treatment outcomes in ethnicities and therefore, should be encouraged in clinical trials.