Reporting, representation, and subgroup analysis of race and ethnicity in published clinical trials of atopic dermatitis in the United States between 2000 and 2009.

ABSTRACT

To review the literature on atopic dermatitis (AD) clinical trials published in the United States between 2000 and 2009 to examine the representation of racial and ethnic minorities in those trials and determine the extent to which investigators reported on demographic variables and performed a subanalysis. A PubMed search was performed including all clinical trials for management of AD published between 2000 and 2009. Three reviewers analyzed articles matching the search criteria. Data recorded included incorporation of demographic data at baseline and in the analysis and result interpretations. Of 645 PubMed search results, only 78 articles originated in the United States and fit the search criteria; 59.5% of these included reports of race or ethnicity. Of the studies reporting race or ethnicity, the subject population mainly included 62.1% white, 18.0% black, 6.9% Asian, and 2.0% Hispanic. Despite increasing awareness in the United States of the importance of reporting demographic data in clinical trials, there has been no significant improvement in reporting in AD clinical trials over the past 10 years. When reporting occurs, the categorization of ethnicities, methods of reporting data, and incorporation of the data into the results are lacking or flawed. In addition, aside from blacks, U.S. minorities appear to be underrepresented in AD clinical trials.