Gatekeeping procedures with clinical trial applications
Article first published online: 21 JUN 2007
Copyright © 2007 John Wiley & Sons, Ltd.
Special Issue: Special Issue on Multiplicity in Pharmaceutical Statistics
Volume 6, Issue 3, pages 171–180, July/September 2007
How to Cite
Dmitrienko, A. and Tamhane, A. C. (2007), Gatekeeping procedures with clinical trial applications. Pharmaceut. Statist., 6: 171–180. doi: 10.1002/pst.291
- Issue published online: 24 AUG 2007
- Article first published online: 21 JUN 2007
- National Institute of Heart
- Lung and Blood Institute
- National Security Agency
- multiple comparisons;
- multiple endpoints;
- clinical trials
The objective of this paper is to give an overview of a relatively new area of multiplicity research that deals with the analysis of hierarchically ordered multiple objectives. Testing procedures for this problem are known as gatekeeping procedures and have found a variety of applications in clinical trials. This paper reviews main classes of these procedures, including serial and parallel gatekeeping procedures, and tree gatekeeping procedures that account for logical restrictions among multiple objectives. We focus on procedures based on marginal p-values; extensions to procedures that exploit the joint distribution of the p-values are also noted. Clinical trial examples are used to illustrate the procedures and their important properties. Copyright © 2007 John Wiley & Sons, Ltd.