Statistical inference for clinical trials with binary responses when there is a shift in patient population.

Journal Article (Journal Article)

In clinical research, it is not uncommon to modify a trial procedure and/or statistical methods of ongoing clinical trials through protocol amendments. A major modification to the study protocol could result in a shift in target patient population. In addition, frequent and significant modifications could lead to a totally different study that is unable to address the medical questions that the original study intended to answer. In this article, we propose a logistic regression model for statistical inference based on a binary study endpoint for trials with protocol amendments. Under the proposed method, sample size adjustment is also derived.

Full Text

Duke Authors

Cited Authors

  • Yang, L-Y; Chi, Y; Chow, S-C

Published Date

  • May 2011

Published In

Volume / Issue

  • 21 / 3

Start / End Page

  • 437 - 452

PubMed ID

  • 21442518

Electronic International Standard Serial Number (EISSN)

  • 1520-5711

Digital Object Identifier (DOI)

  • 10.1080/10543406.2010.481803


  • eng

Conference Location

  • England