Strengths and Limitations
depression
ADVERSE EFFECTS
A strength of this study is its use of FDA data, which include both published and unpublished high-quality randomized clinical trials and their pooled IPD. Another strength is that the population-level findings do not depend on any special assumptions.One limitation of the study is that individual-level findings depend on the rank similarity assumption, which is unproven. Other limitations include lack of associated data and therefore omitted analyses concerning adverse effects, long-term effects, demographic characteristic covariates, and study-specific information. The lack of study-specific information in particular means that we cannot account for between-study heterogeneity, which might otherwise affect the study-adjusted drug and placebo response curves and the magnitude of calculated QTEs. In keeping with other QTE analyses in the literature, we did not attempt an analysis of very finely resolved quantiles, such as the bottom 1% of the population.Moreover, although we do not consider our choice to exclude patients with less severe depression from the analysis as a limitation to the internal validity of our study, this choice potentially limits the generalizability of our results to patients with mild depression. That exclusion further limits direct comparison of our results with those of Stone et al.