• Roger G Spragg, Gordon R Bernard, William Checkley, J Randall Curtis, Ognjen Gajic, Gordon Guyatt, Jesse Hall, Elliott Israel, Manu Jain, Dale M Needham, Adrienne G Randolph, Gordon D Rubenfeld, David Schoenfeld, B Taylor Thompson, Lorraine B Ware, Duncan Young, and Andrea L Harabin.
• Division of Lung Diseases, National Heart, Lung, and Blood Institute/ NIH, 6701 Rockledge Drive, Bethesda, MD 20892-7952, USA. Harabin@nih.gov
• Am. J. Respir. Crit. Care Med. 2010 May 15;181(10):1121-7.

AbstractMortality 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.

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