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Information on ethnic minorities and demographic data from asthma clinical trials does not reach the public domain Evidence from a systematic review and implications for tackling health disparities Geoff Frampton & Jonathan Shepherd Southampton Health Technology Assessments Centre Background Variation in asthma prevalence, morbidity and/or mortality Geographical Racial/ethnic population groups Socioeconomic status Recommendations Minorities and socioeconomic status should be included in clinical trials But… Broad groups lack clinical relevance Genetic polymorphisms useful Southampton Health Technology Assessments Centre Abandon broad classes in favour of most precise population provenance data available and genetic information if appropriate Objective To determine the extent to which minority populations, socioeconomic, demographic and genetic information are reported and analysed in asthma clinical trials Southampton Health Technology Assessments Centre Methods Source of evidence: Systematic reviews of asthma drug effectiveness and safety (SHTAC and PenTAG) National Institute for Health and Clinical Excellence Systematic data (NICE) review andextraction updateofofdemographic guidelines on inhaled corticosteroids and long-acting beta agonists for management of asthma in adults and children Southampton Health Technology Assessments Centre Results 87 randomized controlled trials (RCTs) published in 32 English language journals, 1985 to 2006 Total number of RCTs Number reporting race/ethnicity 14 12 10 8 6 4 2 0 1981 1986 1991 Southampton Health Technology Assessments Centre J : \ S H 1996 2001 2006 Results Of the 87 randomized controlled trials… Baseline data reported Analyzed or discussed with outcomes 23 0 Socio-economic UK-specific variables trials 1 1/ 9 0 Genetic information US-specific trials 0 6/7 0 0 64 4 Race/ethnicity Country / countries of trial (P=0.009, Fisher’s Exact test) Southampton Health Technology Assessments Centre Discussion What are the implications of these findings ? Barriers to placing demographic data in the public domain Generalizability A) Population-specific trials (6 / 23) B) Multi-population trials, baseline data only (17 / 23) C) Multi-population trials with sub-group analyses (0 / 23) Mixed populations Southampton Health Technology Assessments Centre “Ecological fallacy” Discussion Existing asthma evidence hypotheses Asthma variation: Clinical trials Guidance Geographical Racial/ethnic population groups Socioeconomic status Genetic polymorphisms Southampton Health Technology Assessments Centre new evidence Healthcare goals Among others… Reduce and ideally eliminate demographic disparities in asthma prevalence, morbidity, mortality and management Conclusions and recommendations 1. Include evidence-based hypotheses in asthma clinical trials 2. More critically consider clinical trial generalizability 3. Improve the guidance for clinical trials and its impact 4. Encourage the publication of demographic information Thank you for your attention! The views and opinions expressed in this presentation are those of the authors and do not necessarily reflect those of the UK Department of Health Southampton Health Technology Assessments Centre