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

Lan Yan Yang, Yunchan Chi, Shein Chung Chow

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)437-452
Number of pages16
JournalJournal of Biopharmaceutical Statistics
Volume21
Issue number3
DOIs
Publication statusPublished - 2011 May 1

All Science Journal Classification (ASJC) codes

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)

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