LAUSR

Key Points Question Is the interpretation and reporting of noninferiority trials with primary end point results that are not statistically significant correct, and what are the associated factors of misleading reporting? Findings This systematic review of 52 noninferiority randomized clinical trials of cancer treatments with results for primary end points that are not statistically significant, 75% included misleading reporting. Multivariable analysis found that the prevalence of misleading reporting was significantly lower in reports with funding from for-profit sources and higher in reports of novel experimental treatments. Meaning These findings suggest that authors should carefully consider noninferiority cancer clinical trial result interpretation and reporting, especially for primary outcome results that are not statistically significant.