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Statistical methods for two-sequence three-period cross-over designs with incomplete data.

Publication ,  Journal Article
Chow, SC; Shao, J
Published in: Stat Med
May 15, 1997

In clinical trials, and in bioavailability and bioequivalence studies, one often encounters replicate cross-over designs such as a two-sequence three-period cross-over design to assess treatment and carry-over effects of two formulations of a drug product. Because of the potential dropout (or for some administrative reason), however, the observed data set from a replicate cross-over design is incomplete or unbalanced so that standard statistical methods for a cross-over design may not apply directly. For inference on the treatment and carry-over effects, we propose a method based on differences of the observations that eliminates the random subject effects and thus does not require any distributional condition on the random subject effects. When no datum is missing, this method provides the same results as the ordinary least squares method. When there are missing data, the proposed method still provides exact confidence intervals for the treatment and carry-over effects, as long as the dropout is independent of the measurement errors. We provide an example for illustration.

Duke Scholars

Published In

Stat Med

DOI

ISSN

0277-6715

Publication Date

May 15, 1997

Volume

16

Issue

9

Start / End Page

1031 / 1039

Location

England

Related Subject Headings

  • Statistics as Topic
  • Statistics & Probability
  • Research Design
  • Random Allocation
  • Premenstrual Syndrome
  • Models, Statistical
  • Mathematics
  • Linear Models
  • Least-Squares Analysis
  • Humans
 

Citation

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Chow, S. C., & Shao, J. (1997). Statistical methods for two-sequence three-period cross-over designs with incomplete data. Stat Med, 16(9), 1031–1039. https://doi.org/10.1002/(sici)1097-0258(19970515)16:9<1031::aid-sim519>3.0.co;2-6
Chow, S. C., and J. Shao. “Statistical methods for two-sequence three-period cross-over designs with incomplete data.Stat Med 16, no. 9 (May 15, 1997): 1031–39. https://doi.org/10.1002/(sici)1097-0258(19970515)16:9<1031::aid-sim519>3.0.co;2-6.
Chow, S. C., and J. Shao. “Statistical methods for two-sequence three-period cross-over designs with incomplete data.Stat Med, vol. 16, no. 9, May 1997, pp. 1031–39. Pubmed, doi:10.1002/(sici)1097-0258(19970515)16:9<1031::aid-sim519>3.0.co;2-6.
Journal cover image

Published In

Stat Med

DOI

ISSN

0277-6715

Publication Date

May 15, 1997

Volume

16

Issue

9

Start / End Page

1031 / 1039

Location

England

Related Subject Headings

  • Statistics as Topic
  • Statistics & Probability
  • Research Design
  • Random Allocation
  • Premenstrual Syndrome
  • Models, Statistical
  • Mathematics
  • Linear Models
  • Least-Squares Analysis
  • Humans