Professor Eric Benoit from Brown Medial School spoke at Brown Public on September 25, 2019 about, Mortality as an endpoint in clinical trials of trauma & critical illness. Hosted by CESH.
Randomized controlled trials (RCTs) remain the gold standard for determining the efficacy of novel therapies. Critically ill or injured patients have the highest risk of death, and mortality is often used as an endpoint in clinical trials in these populations. Yet despite improvements in medical care over time, few RCTs have demonstrated a mortality benefit in these sickest of patients. Are our treatments not effective, or is mortality too messy an endpoint to allow detection of a clear therapeutic benefit? Trials may fail to reach significance for reasons other than ineffective interventions, and we therefore discuss characteristics of RCT design that influence results, such as estimated event rates in the control group and predicted treatment effects. We review the critical care landscape and present a systematic review of RCTs in trauma over the past 30 years. In this era of evidence-based medicine, we need well-designed clinical trials to advance the treatment of trauma and critical illness. And as readers we must be prepared to assess the strength of this evidence.