title: Clinical trial design in prevention and treatment of acute respiratory distress syndrome.
abstract: Our ability to define appropriate molecular targets for preclinical development and develop better methods needs to be improved, to determine the clinical value of novel acute respiratory distress syndrome (ARDS) agents. Clinical trials must have realistic sample sizes and meaningful end points and use the available observation and meta-analytical data to inform design. Biomarker-driven studies or defined ARDS subsets should be considered to categorize specific at-risk populations most likely to benefit from a new treatment. Innovations in clinical trial design should be pursued to improve the outlook for future interventional trials in ARDS.
authors.affiliation: Department of Anesthesia, Keenan Research Centre for Biomedical Science, Li Ka Shing Knowledge Institute, St Michael's Hospital, 30, Bond Street, Toronto, Ontario M5B 1W8, Canada.
authors.forename: Gerard F
authors.initials: GF
authors.lastname: Curley
authors.affiliation: School of Medicine, Dentistry and Biomedical Science, Centre for Infection and Immunity, Queen's University Belfast, Health Sciences Building, 97 Lisburn Road, Belfast, Northern Ireland BT9 7BL, UK. Electronic address: d.f.mcauley@qub.ac.uk.
authors.forename: Daniel F
authors.initials: DF
authors.lastname: McAuley
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D012107:Research Design; D012128:Respiratory Distress Syndrome / Q000628:therapy*
keywords: Acute respiratory distress syndrome; Clinical trial design; Prevention; Treatment