Data monitoring committees and interim monitoring guidelines.


Journal Article (Review)

Most large randomized clinical trials have a data monitoring committee that periodically examines efficacy and safety results. A typical data monitoring committee meets every 6 months, but the interim monitoring guidelines for many trials specify formal analyses that are years apart. In this article we argue that study protocols should include monitoring guidelines with formal looks at each data monitoring committee meeting. Such guidelines are shown to reduce the average duration of a trial with negligible effect on power and estimation bias. Some of the common statistical monitoring guidelines require extreme evidence to stop a trial early and do not distinguish between stopping a trial during active accrual and follow-up stages. We propose practical solutions for these issues.

Full Text

Duke Authors

Cited Authors

  • Freidlin, B; Korn, EL; George, SL

Published Date

  • October 1999

Published In

Volume / Issue

  • 20 / 5

Start / End Page

  • 395 - 407

PubMed ID

  • 10503800

Pubmed Central ID

  • 10503800

International Standard Serial Number (ISSN)

  • 0197-2456

Digital Object Identifier (DOI)

  • 10.1016/s0197-2456(99)00017-3


  • eng

Conference Location

  • United States