Demographic data in asthma clinical trials: A systematic review with implications for generalizing trial findings and tackling health disparities

The prevalence of asthma, and the morbidity, adverse events, mortality and healthcare utilisation of asthmatic patients vary widely among racial/ethnic and other socio-demographic groups. Debates over the meanings of race and ethnicity and the strategic need to resolve health inequalities have prompted extensive recommendations for reporting and analyzing racial/ethnic and demographic information in clinical trials. We conducted a systematic review to determine the extent to which race/ethnicity, socio-economic status and other demographic variables are analyzed and reported in publications from randomized controlled trials of asthma interventions. Randomized controlled trials of inhaled corticosteroids and long-acting [beta]-agonists in asthmatic patients were identified by systematically searching 12 electronic bibliographic databases. We identified peer-reviewed papers reporting 87 relevant trials published during 1985-2006, from which we extracted data on patients' race/ethnicity, ancestry, gender, socio-economic variables and geographical attributes. The proportion of the papers reporting the race/ethnicity of their participants was lower than would be expected by chance and has recently declined. None of the papers included race/ethnicity or gender in statistical analyses or reported socio-economic variables, ancestry, or genetic data for their participants, and few discussed the generalizability of their findings. The frequency of reporting race/ethnicity was statistically significantly lower in trials conducted in the UK than in the US, but 23 of the 87 papers did not identify countries. Despite extensive recommendations in the literature, guidance from health agencies on analyzing and reporting demographic data in clinical trials still appears inconsistent and vague. There remains a need to improve guidance on the representation and analysis of minority populations in asthma clinical trials, in order to encourage transparent reporting of population selection, analysis approaches, and trial generalizability. To assist this process, asthma clinical trials should be based on clear hypotheses that link both to existing demographic evidence and to demographic healthcare goals.