Abstract
Prognostic factor analysis refers to the adjustment of covariates when comparing treatments in a randomized clinical trial. This chapter covers various methodological issues related to prognostic factor analysis, including its importance to the randomization and primary analysis of the trial, statistical model building, selection of prognostic factors, and the study of interactions and subgroups, among others. Methodological discussion is illustrated with data examples, and some commonly made mistakes in statistical practice are identified and discussed. This chapter is intended to provide readers with practical advice on how to use prognostic factors in the design, analysis, and reporting of randomized clinical trials.
Original language | English (US) |
---|---|
Title of host publication | Principles and Practice of Clinical Trials |
Publisher | Springer International Publishing |
Pages | 1771-1787 |
Number of pages | 17 |
ISBN (Electronic) | 9783319526362 |
ISBN (Print) | 9783319526355 |
DOIs | |
State | Published - Jan 1 2022 |
Keywords
- Analysis of covariance
- ANCOVA
- Baseline covariate
- Covariate adjustment
- Regression model
- Stratified analysis
- Stratified randomization
- Subgroup analysis
ASJC Scopus subject areas
- General Medicine
- General Mathematics