Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy

This study compares the published data on a dozen antidepressant drugs with analyses of the same drugs by the Food and Drug Administration. The results of studies in the entire database were less likely to be favorable to the drug than those in the published literature. This study compares the published data on a dozen antidepressant drugs with analyses of the same drugs by the FDA. The results of studies in the entire database were less likely to be favorable to the drug than those in the published literature. Medical decisions are based on an understanding of publicly reported clinical trials.1,2 If the evidence base is biased, then decisions based on this evidence may not be the optimal decisions. For example, selective publication of clinical trials, and the outcomes within those trials, can lead to unrealistic estimates of drug effectiveness and alter the apparent risk–benefit ratio.3,4 Attempts to study selective publication are complicated by the unavailability of data from unpublished trials. Researchers have found evidence for selective publication by comparing the results of published trials with information from surveys of authors,5 registries,6 institutional review boards,7,8 and . . .