Th e therapeutic potential of gene therapy for ALI/ARDS is underlined by a growing body of literature demon strating effi cacy in relevant preclinical models. In considering the clinical implications of these studies, it is important to acknowledge that animal models of ARDS do not fully replicate the complex pathophysiological changes seen in the clinical setting. Th is is highlighted by the fact that many pharmacologic strategies demonstrating considerable promise in preclinical studies were later proven ineff ective in clinical trials. Nevertheless, these studies provide insights into the clinical potential of these strategies.