This report summarizes the findings of a workshop convened by the Division of Lung Diseases of the National Heart, Lung, and Blood Institute on August 5-6, 2009. The goal of the workshop was to assess the current state of clinical research in acute lung injury (ALI) and the acute respiratory distress syndrome (ARDS), identify research needs, and develop recommendations for clinical research in the near future.
Data on mortality attributable to ALI are conflicting, but both longitudinal observations at single institutions and the experience of the NHLBI ARDS Clinical Trials Network suggest a substantial decline over the past two decades. Studies from the Network permit comparison of mortalities in patients of similar disease severity and source, and in these studies mortality has fallen from 40% in studies conducted in the late 1990’s (ARMA) to the low 20s in the most recent reports (FACTT). Consequently, clinical trials powered to detect differences in mortality may require ever increasing numbers of patients. The panel was charged to examine whether novel investigational strategies might allow studies enrolling smaller numbers of patients, and to consider other types of clinical research that would advance the science and treatment of ALI/ARDS. The group included pulmonary critical care and cardiovascular clinician scientists experienced in the design and conduct of clinical research as well as statistical and genetic experts.
Panelists were asked to consider issues in the following areas:
Last Updated June 2011