reviewNew England Journal of MedicineJan 16, 2008Closed access

Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy

Oregon Health & Science University · Veterans Health Administration · +3 more institutions

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Abstract

Background

Evidence-based medicine is valuable to the extent that the evidence base is complete and unbiased. 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.

Methods

We obtained reviews from the Food and Drug Administration (FDA) for studies of 12 antidepressant agents involving 12,564 patients. We conducted a systematic literature search to identify matching publications. For trials that were reported in the literature, we compared the published outcomes with the FDA outcomes. We also compared the effect size derived from the published reports with the effect size derived from the entire FDA data set.

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