Evaluation of ventricular arrhythmias in early clinical pharmacology trials and potential consequences for later development.

Published

Journal Article (Review)

This white paper, prepared by members of the Cardiac Safety Research Consortium, discusses several important issues regarding the evaluation of ventricular arrhythmias in early clinical pharmacology trials and their potential consequences for later clinical drug development. Ventricular arrhythmias are infrequent but potentially important medical events whose occurrence in early clinical pharmacology trials can dramatically increase safety concerns. Given the increasing concern with all potential safety signals and the resultant more extensive electrocardiographic monitoring of subjects participating in early phase trials, an important question must be addressed: Are relatively more frequent observations of ventricular arrhythmias related simply to more extensive monitoring, or are they genuinely related to the drug under development? The discussions in this paper provide current thinking and suggestions for addressing this question.

Full Text

Duke Authors

Cited Authors

  • Min, SS; Turner, JR; Nada, A; DiMino, TL; Hynie, I; Kleiman, R; Kowey, P; Krucoff, MW; Mason, JW; Phipps, A; Newton-Cheh, C; Pordy, R; Strnadova, C; Targum, S; Uhl, K; Finkle, J

Published Date

  • May 2010

Published In

Volume / Issue

  • 159 / 5

Start / End Page

  • 716 - 729

PubMed ID

  • 20435178

Pubmed Central ID

  • 20435178

Electronic International Standard Serial Number (EISSN)

  • 1097-6744

International Standard Serial Number (ISSN)

  • 0002-8703

Digital Object Identifier (DOI)

  • 10.1016/j.ahj.2010.02.004

Language

  • eng