Medizinische Sicherheit und globale Gesundheit
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Sensitivity versus Specificity in the Evaluation of Adverse Event Data from Clinical Trial

Miao J, Lai TL, Chen J and Heyse JF

The evaluation of safety is an important part of clinical trials of pharmaceutical, biological, and vaccine products. In early phase trials, the evaluation is mostly exploratory with a focus primarily on serious adverse reactions to the candidate product. In later phases of clinical development programs the safety profile is characterized more fully using larger numbers of patients. Unlike the evaluation of drug efficacy, the outcome of which is based on a single or a collection of prespecific hypotheses, the hypotheses to test to conclude a drug has potential safety burden is generally not prespecified. The test and conclusion of potential safety issue of a drug are usually based on an arbitrary number of reports of adverse events that have not been identified at the outset, which amounts to using observed data to test hypotheses that are generated by the same data.