Crossover Studies with Binary Responses

Ton J. Cleophas, Aeilko H. Zwinderman and Toine F. Cleophas
Additional contact information
Ton J. Cleophas: European Interuniversity College of Pharmaceutical Medicine Lyon
Aeilko H. Zwinderman: Academic Medical Center Amsterdam, Department Biostatistics and Epidemiology
Toine F. Cleophas: Technical University

Chapter Chapter 20 in Statistics Applied to Clinical Trials, 2006, pp 229-237 from Springer

Abstract: Abstract The crossover design is widely used in clinical research especially in the case of a limited number of patients. The main advantage of within-patient over between-patient comparisons is that between-subject variability is not used in the comparisons. However, a prerequisite is that the order of the treatments does not influence the outcome of the treatment. If the effect of the treatment administered in the 1st period carries on into the 2nd period, then it may influence the measured response in the 2nd period. This essentially means that only symptomatic treatments qualify for crossover comparisons and curative treatments do not. However, symptomatic treatments frequently have small curative effects, e.g., wound healing by vasodilators or, more recently, cardiac remodelling by afterload reduction. The treatment group that is treated with the effective compound first and with the less effective compound or placebo second is frequently biased by carryover effect from the 1 st period into the 2nd, whereas the alternative group that is treated in the reverse order is not so.1 For example, of 73 recently published crossovers only 6 reported the data of the separate periods. In 5 of them (83%) this very type of carryover effect was demonstrable. Such a mechanism may cause a severe underestimation of the treatment results2 and this possibility should, therefore, be assessed in the analysis. Most of the reports on the subject of order effects so far have addressed crossover studies with a quantitative rather than binary response.3–10

Keywords: Carryover Effect; Crossover Trial; Crossover Design; Binary Response; Severe Underestimation (search for similar items in EconPapers)
Date: 2006
References: Add references at CitEc
Citations:

There are no downloads for this item, see the EconPapers FAQ for hints about obtaining it.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-1-4020-4650-6_20

Ordering information: This item can be ordered from
http://www.springer.com/9781402046506

DOI: 10.1007/978-1-4020-4650-6_20

Access Statistics for this chapter

More chapters in Springer Books from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().