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Mortality in National Heart, Lung and Blood Institute-sponsored clinical trials of treatments for acute lung injury (ALI) has decreased dramatically during the past two decades. As a consequence, design of such trials based on a mortality outcome requires ever-increasing numbers of patients. Recognizing that advances in clinical trial design might be applicable to these trials and might allow trials with fewer patients, the National Heart, Lung and Blood Institute convened a workshop of extramural experts from several disciplines. The workshop assessed the current state of clinical research addressing ALI, identified research needs, and recommended: (1) continued performance of trials evaluating treatments of patients with ALI; (2) development of strategies to perform ALI prevention trials; (3) observational studies of patients without ALI undergoing prolonged mechanical ventilation; and (4) development of a standardized format for reporting methods, endpoints, and results of ALI trials.

Original publication

DOI

10.1164/rccm.201001-0024WS

Type

Journal article

Journal

Am J Respir Crit Care Med

Publication Date

15/05/2010

Volume

181

Pages

1121 - 1127

Keywords

Acute Lung Injury, Biomedical Research, Clinical Trials as Topic, Forecasting, Humans, Respiratory Distress Syndrome, Adult