• Richard H Kallet.
• Department of Anesthesia, University of California, San Fransisco, CA, USA. rkallet@sfghsom.ucsf.edu
• Resp Care. 2009 Jul 1; 54 (7): 912-24.

AbstractIt has been almost 15 years since the National Institutes of Health created the Acute Respiratory Distress Syndrome Clinical Trials Network (ARDS Network) and nearly a decade since the completion of the landmark low-tidal volume (V(T)) trial. In retrospect, the ARDS Network had a profound impact on the design and conduct of clinical trials in critical care. It represented the first time the federal government funded a clinical trials network devoted to Phase-III testing of important, non-pharmacologic therapies. Also the ARDS Network introduced factorial design into critical-care research, which allowed Phase-II testing of promising therapies. Other important contributions from the ARDS Network may not become apparent for many years. These include the ongoing mentoring of a new generation of critical-care researchers, as well as continued testing on an enormous store of biological samples that inevitably will advance our understanding of the pathogenesis of ARDS. Perhaps someday this may lead to another therapeutic breakthrough. Part of the ARDS Network's legacy surely will have been the opening of a dialog regarding the design of clinical trials in critical care, as well as a concerted effort to improve the protection of subjects enrolled into those trials. Finally, the respiratory care profession itself has benefited, owing both to its critical role in the successful implementation of complicated therapist-driven protocols and also to the ARDS Network's novel practice of utilizing respiratory therapists as clinical coordinators. This has raised the profile and enhanced the stature of the respiratory care profession.

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