Format

Send to

Choose Destination
See comment in PubMed Commons below
J Biopharm Stat. 2009 Jul;19(4):685-99. doi: 10.1080/10543400902964142.

Noninferiority trial design and analysis with an ordered three-level categorical endpoint.

Author information

1
Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland 20892, USA. ebrittain@niaid.nih.gov

Abstract

This paper extends standard methodology for noninferiority trial design from a binary endpoint to an ordered three-level endpoint, such as "success," "intermediate," and "failure." A metric that summarizes outcome on this endpoint is proposed, and the corresponding sample size requirements are presented. This ordered endpoint can be collapsed into two different binary endpoints, respectively lumping "intermediate" outcomes with "success" or with "failure." We describe how the ordered three-level endpoint compares with these two binary endpoints with respect to the noninferiority margin and sample size requirements.

PMID:
20183434
PMCID:
PMC2893351
DOI:
10.1080/10543400902964142
[Indexed for MEDLINE]
Free PMC Article
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for PubMed Central
    Loading ...
    Support Center