The care provided for critically ill infants and children should be based on the highest level of evidence. Within the quantitative research paradigm this evidence includes data from several Phase 3 clinical trials—clinical trials that are adequately powered and enroll enough subjects to definitively answer the research question. Though necessary, few adequately powered clinical trials exist to support nursing practice in pediatric critical care. Much of what we know about taking care of sick children is extrapolated from clinical trials conducted primarily in adult or neonatal populations. The good news is that this phenomenon is changing. Currently, several large multicenter clinical trials are enrolling hundreds of pediatric critically ill subjects across the United States. Now more than ever, clinicians need to be clear on their unique roles and responsibilities when their patient qualifies for or is in enrolled in a clinical trial.

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