Monitoring versus interim analysis of clinical trials: a perspective from the pharmaceutical industry.

Journal Article (Journal Article)

The definitions of "interim analysis" and "monitoring" of clinical trials are often ambiguous in the current literature. The resulting confusion can lead to erroneous conclusions and misguided decisions, especially when activities that are operational or observational are evaluated in a probabilistic sense as inferential. The authors seek to define "interim analysis" and "monitoring" in a mutually exclusive fashion. These definitions will then provide the opportunity to review and categorize existing clinical trial practices and procedures. This will clarify such issues as "when to look" and "when to pay a price" (e.g., test size and power) and characterize such issues in the context of pharmaceutical industry drug development.

Full Text

Duke Authors

Cited Authors

  • Enas, GG; Dornseif, BE; Sampson, CB; Rockhold, FW; Wuu, J

Published Date

  • March 1989

Published In

Volume / Issue

  • 10 / 1

Start / End Page

  • 57 - 70

PubMed ID

  • 2702837

International Standard Serial Number (ISSN)

  • 0197-2456

Digital Object Identifier (DOI)

  • 10.1016/0197-2456(89)90018-4


  • eng

Conference Location

  • United States