Sensitivity versus Specificity in the Evaluation of Adverse Event Data from Clinical Trial
Miao J*, Lai TL, Chen J and Heyse JF
Department of Statistics, Stanford University, CA, USA
- *Corresponding Author:
- Jing Miao
Department of Statistics
CA 94305, USA
Tel: +1650 7232300
E-mail: [email protected]
Received Date: May 11, 2017; Accepted Date: May 22, 2017; Published Date: May 30, 2017
Citation: Miao J, Lai TL, Chen J, Heyse JF (2017) Sensitivity versus Specificity in the Evaluation of Adverse Event Data from Clinical Trial. Med Saf Glob Health 6:133.
Copyright: © 2017 Miao J, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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 thecandidate product. In later phases of clinical development programs the safety profile is characterized more fully usinglarger numbers of patients. Unlike the evaluation of drug efficacy, the outcome of which is based on a single or acollection of prespecific hypotheses, the hypotheses to test to conclude a drug has potential safety burden is generallynot prespecified. The test and conclusion of potential safety issue of a drug are usually based on an arbitrary numberof 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.