1. 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

2. Background Southampton Health Technology Assessments Centre Variation in asthma prevalence, morbidity and/or mortality Geographical Racial/ethnic population groups Socioeconomic status Abandon broad classes in favour of most precise population provenance data available and genetic information if appropriate Broad groups lack clinical relevance Genetic polymorphisms useful But… Minorities and socio- economic status should be included in clinical trials Recommendations

3. Southampton Health Technology Assessments Centre Objective To determine the extent to which minority populations, socioeconomic, demographic and genetic information are reported and analysed in asthma clinical trials

4. Methods Southampton Health Technology Assessments Centre National Institute for Health and Clinical Excellence (NICE) review and update of guidelines on inhaled corticosteroids and long-acting beta agonists for management of asthma in adults and children Systematic reviews of asthma drug effectiveness and safety (SHTAC and PenTAG) Source of evidence: Systematic extraction of demographic data

5. Southampton Health Technology Assessments Centre Results 87 randomized controlled trials (RCTs) published in 32 English language journals, 1985 to 2006 0 2 4 6 8 10 12 14 198119861991199620012006 Total number of RCTs J:\SHTAC\Projects\Research\Healthcare Associated Infections\Catheter education in critical care\Correspondence with expertsJ:\SHTAC\Projects\Research\Healthcare Associated Infections\Catheter education in critical care\Correspondence with experts Number reporting race/ethnicity

6. Southampton Health Technology Assessments Centre Of the 87 randomized controlled trials… Results 10Socio-economic variables 230 Baseline data reported Analyzed or discussed with outcomes Race/ethnicity 0 0 Genetic information 64 4 Country / countries of trial (P=0.009, Fisher’s Exact test) UK-specific trials US-specific trials 1 / 9 6 / 7 0 0

7. Southampton Health Technology Assessments Centre What are the implications of these findings ? Discussion 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) Barriers to placing demographic data in the public domain Generalizability “Ecological fallacy”Mixed populations

8. Southampton Health Technology Assessments Centre hypotheses new evidence Existing asthma evidence Healthcare goals Clinical trials Discussion Asthma variation: Geographical Racial/ethnic population groups Socioeconomic status Genetic polymorphisms Among others… Reduce and ideally eliminate demographic disparities in asthma prevalence, morbidity, mortality and management Guidance

9. Southampton Health Technology Assessments Centre Conclusions and recommendations 2. More critically consider clinical trial generalizability 1. Include evidence-based hypotheses in asthma clinical trials 3. Improve the guidance for clinical trials and its impact 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 Thank you for your attention! 4. Encourage the publication of demographic information