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

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

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

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

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

1981 1986 1991 1996 2001 2006

Total number of RCTs

J:\SHTAC\Projects\Research\Healthcare Associated Infections\Catheter education in critical care\Correspondence with experts

Number reporting race/ethnicity

Southampton Health Technology Assessments Centre

Of the 87 randomized controlled trials…

Results

1 0Socio-economic variables

23 0

Baseline data reported

Analyzed or discussed with

outcomes

Race/ethnicity

0 0Genetic information

64 4Country / countries of trial

(P=0.009, Fisher’s Exact test)

UK-specific trials

US-specific trials

1 / 9

6 / 7

0

0

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

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

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