Clinical trials and tribulations: the MASCOT study.
نویسندگان
چکیده
INTRODUCTION Following the 1994 Lancet paper showing benefits of long-acting b-agonists (LABAs) in adults with asthma, British Paediatric Respiratory Society surveys have consistently recommended undertaking similar studies appropriately designed for children. Adult outcome measures should not be extrapolated into childhood, which explains why early studies indicated LABAs may be less helpful in children. With the advent of the Medicines for Children Research Network (MCRN) in 2004, the Health Technology Assessment (HTA) put out a call for children’s medicines studies in 2005. The Management of Asthma in School Children On Therapy (MASCOT) study was funded in January 2006 pending Pharma approval to supply the medicines (fluticasone, fluticasonee salmeterol combination treatment and montelukast) as National Institute for Health Research funding does not include excess treatment costs. This task took 12 months including lengthy discussions with Merck, Sharp and Dome (MSD) about methodology and statistics.
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عنوان ژورنال:
- Thorax
دوره 66 6 شماره
صفحات -
تاریخ انتشار 2011