Safety Monitoring

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

This chapter deals with statistical methods used in safety monitoring. The methods described here are those that are used to capture safety signals of a clinical trial in progress rather than to summarize the entire safety profile of a completed trial or integrate the safety data of a particular trial with those of other trials in the same clinical program. The chapter describes some useful steps for the planning for safety monitoring. The statistical methodology is discussed in two parts: methods used by the sponsor and those employed by the data monitoring committee (DMC). The chapter focuses on what statistical methods and operations are most essential for safety monitoring. It concludes with a discussion on the challenges of emerging issues such as adaptive designs, real-time serious adverse events (SAEs) reporting via the internet, the anticipated merger of healthcare delivery and clinical trials, and the high-tech future of drug safety.

Original languageEnglish (US)
Title of host publicationStatistical Methods for Evaluating Safety in Medical Product Development
PublisherWiley-Blackwell
Pages293-318
Number of pages26
ISBN (Electronic)9781118763070
ISBN (Print)9781119979661
DOIs
StatePublished - Feb 23 2015

Keywords

  • Bayesian methods
  • Data monitoring committee (DMC)
  • Drug safety
  • Likelihood methods
  • Safety monitoring
  • Serious adverse events (SAEs)
  • Sponsor staff

ASJC Scopus subject areas

  • Psychology(all)

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