Cultural Diversity |

Race/Ethnicity Reporting for Pulmonary Clinical Trials in ClinicalTrials.gov FREE TO VIEW

Isaretta Riley, MD; L. Ebony Boulware, MD; Jie-Lena Sun, MS; Karen Chiswell, PhD; Loretta Que, MD; Robert Califf, MD; Monica Kraft, MD; Monique Anderson, MD
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Duke University School of Medicine, Durham, NC

Chest. 2015;148(4_MeetingAbstracts):357A. doi:10.1378/chest.2235991
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SESSION TITLE: Race and Ethnicity in Lung Disease

SESSION TYPE: Original Investigation Slide

PRESENTED ON: Monday, October 26, 2015 at 04:30 PM - 05:30 PM

PURPOSE: 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. In 2007 the Food and Drug Administration Amendment Act (FDAAA) mandated that clinical trials report summary results to ClinicalTrials.gov. Demographic data are required to be reported in basic summary results, but reporting of race/ethnicity is optional. We sought to characterize reporting of race/ethnicity in pulmonary trials to ClinicalTrials.gov.

METHODS: Using a validated algorithm, we identified pulmonary trials likely subject to FDAAA (i.e., phase 2-4 interventions, FDA-regulated biologics, drugs, or devices, at least one site in the US, or investigational drug or device), called highly likely applicable clinical trials (HLACTs), between 2008 and 2012. We examined race/ethnicity reporting through September 2013 among HLACTs by pulmonary disease type (i.e., asthma, COPD, neoplasm, other) and year of result reporting. We also identified factors independently associated with any race/ethnicity reporting in multivariable logistic regression models which accounted for type of study, phase, funding source, year of completion, and disease type.

RESULTS: Our algorithm identified 1,450 HLACTs studying pulmonary diseases. Over half of pulmonary HLACTs reported results by September 2013 (n=619, KM estimate of 55.1% reporting within 5 years). Of these, 143 (23.1%) reported the race/ethnicity of its participants. Biologic trials had a statistically significantly lower odds of reporting race/ethnicity when compared to drug trials, OR 0.37, 95% CI 0.18-0.77. Trials completed more recently had statistically significantly greater odds of reporting race/ethnicity, (OR 2.17 95% CI 1.07-4.40 for trials completed in 2013 compared to 2009) compared to earlier trials. Trials studying asthma [OR 2.14 95% CI 1.21-3.77] and COPD [OR 1.98 95% CI 1.08-3.63] also had statistically significantly greater odds of reporting race/ethnicity when compared to other pulmonary trials.

CONCLUSIONS: Few pulmonary HLACTs reported race/ethnicity in ClinicalTrials.gov. Reporting was particularly low among biologic trials, while trials completed recently and studying asthma and COPD were more likely to report race or ethnicity.

CLINICAL IMPLICATIONS: Efforts to encourage race/ethnicity reporting among pulmonary trials could help elucidate treatment effects among ethnic/racial minorities.

DISCLOSURE: The following authors have nothing to disclose: Isaretta Riley, L. Ebony Boulware, Jie-Lena Sun, Karen Chiswell, Loretta Que, Robert Califf, Monica Kraft, Monique Anderson

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