Abstract
We consider the management of safety signals that arise in the context of endpoint trials. Such trials have design features which permit the detection of signals that otherwise may be missed in more traditional settings. However, the approaches that are typically employed to address them are less than satisfactory in terms of both the analytical techniques and the communication of the findings. In this paper, alternative approaches are evaluated, and recommendations are given for a comprehensive strategy that involves appropriate use of study data as well as information external to the study. It is emphasized that formulation and implementation of an effective communication plan that enables informed decision making should be an integral component of the strategy.
Keywords: Endpoint trials, competing risks, safety evaluation, cardiovascular risk
Current Drug Safety
Title: Managing Safety Signals in Large Endpoint Trials
Volume: 3 Issue: 2
Author(s): Demissie Alemayehu
Affiliation:
Keywords: Endpoint trials, competing risks, safety evaluation, cardiovascular risk
Abstract: We consider the management of safety signals that arise in the context of endpoint trials. Such trials have design features which permit the detection of signals that otherwise may be missed in more traditional settings. However, the approaches that are typically employed to address them are less than satisfactory in terms of both the analytical techniques and the communication of the findings. In this paper, alternative approaches are evaluated, and recommendations are given for a comprehensive strategy that involves appropriate use of study data as well as information external to the study. It is emphasized that formulation and implementation of an effective communication plan that enables informed decision making should be an integral component of the strategy.
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Cite this article as:
Alemayehu Demissie, Managing Safety Signals in Large Endpoint Trials, Current Drug Safety 2008; 3 (2) . https://dx.doi.org/10.2174/157488608784529206
DOI https://dx.doi.org/10.2174/157488608784529206 |
Print ISSN 1574-8863 |
Publisher Name Bentham Science Publisher |
Online ISSN 2212-3911 |
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