Is your standard, my standard? Why control arm reporting matters in pediatric clinical trials

摘要

Randomized control trials (RCTs) are the corner stone of evidence-based medicine. RCTs are designed to determine whether anintervention is more effective than the current offered treatmentregimen. In RCTs the control arm or comparator forms thebaseline of relative effectiveness or safety for the intervention inthe study population. Comparator bias occurs when the interven-tion arm is given an unfair advantage through selecting a controlarm that does not reflect current practice, or lower or higher dosesof comparator are used. 1 Avoiding comparator bias whenselecting a control arm is critical, for example, using a lower doseof an available treatment that is not supported by currentevidence could make the intervention more likely to show positiveresults.