The acute respiratory distress syndrome network controversy: lessons and legacy.
OBJECTIVE
Several of the Acute Respiratory Disease Syndrome Network clinical trials embrace a clinical trial design that evaluates contrasting strategies, one or both of which represents only a segment of standard practices. Such a trial design has engendered ethical controversy regarding the value of such trials and their ability to protect human subjects. During the past year, commentators have continued to reflect on the significance of such trials.


RESULTS
Several authors have reflected on the ethical significance of the standard of care in clinical trial design and have offered a framework for determining control group selection in critical care trials. Other authors have written on methodologic issues and approaches to determine whether control groups are reflective of standard practices. Surveys have been performed to determine the impact and hence the relevancy of the Acute Respiratory Disease Syndrome Network tidal volume trial on clinical practice.


CONCLUSIONS
The controversy related to and the impact of the Acute Respiratory Disease Syndrome Network clinical trial design on clinical practice offer an opportunity to explore the trade-offs between explanatory and pragmatic types of clinical trials. Such discussions will lead to a clearer understanding of the value of both types of clinical trials and the optimal ethical conduct of such trials.
Silverman
Henry J
HJ
Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland 21201, USA. hsilverm@medicine.umaryland.edu
D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards; D035061:Control Groups; D003422:Critical Care; D032984:Ethics, Research; D006801:Humans; D005791:Patient Care / Q000941:ethics; D018579:Patient Selection / Q000941:ethics; D012107:Research Design / Q000592:standards; D012128:Respiratory Distress Syndrome / Q000628:therapy*