The utility of partial cross-over designs in early phase randomized prevention trials

Alan D Hutson; Mary E Reid

doi:10.1016/j.cct.2004.07.005

The utility of partial cross-over designs in early phase randomized prevention trials

Control Clin Trials. 2004 Oct;25(5):493-501. doi: 10.1016/j.cct.2004.07.005.

Authors

Alan D Hutson¹, Mary E Reid

Affiliation

¹ University at Buffalo, Department of Biostatistics, Farber Hall Room 249A, 3435 Main St., Buffalo, NY 14214-3000, USA.

PMID: 15465618
DOI: 10.1016/j.cct.2004.07.005

Abstract

In this note, we outline the benefits of a partial cross-over design for a class of experiments where the interest is the cumulative effect of dose versus placebo. The goal of our design strategy is to answer several complex question efficiently in a phase II setting with a minimal number of assumptions with an eye towards planning a phase III study.

Publication types

Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

MeSH terms

Clinical Trials, Phase II as Topic
Cross-Over Studies*
Double-Blind Method
Humans
Randomized Controlled Trials as Topic*

Grants and funding

CA49764-15/CA/NCI NIH HHS/United States