We discuss using prediction as a flexible and practical approach for monitoring futility in clinical trials with two co-primary endpoints (CPE). This approach is appealing in that it provides quantitative evaluation of potential effect sizes and associated precision, and can be combined with flexible error-spending strategies. We extend prediction of effect size estimates and the construction of predicted intervals to the two CPE case, and illustrate interim futility monitoring of treatment effects using prediction with an example. We also discuss alternative approaches based on the conditional and predictive powers, compare these methods and provide some guidance on the use of prediction for better decision in clinical trials with CPE.
Reference Type
Journal Article
Periodical Full
Statistics in biopharmaceutical research
Publication Year
2020
Publication Date
Apr 2,
Volume
12
Issue
2
Start Page
164
Other Pages
175
Publisher
Taylor & Francis
Place of Publication
United States
ISSN/ISBN
1946-6315
Document Object Index
10.1080/19466315.2019.1677494
URL
http://www.tandfonline.com/doi/abs/10.1080/19466315.2019.1677494
PMID
33042476