• Henry J Silverman.
• Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland 21201, USA. hsilverm@medicine.umaryland.edu
• Curr Opin Crit Care. 2004 Dec 1; 10 (6): 560-4.

Purpose Of ReviewSeveral 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.Recent FindingsSeveral 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.SummaryThe 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.

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