NAME: Drug Interaction
TYPE: Designed experiment in humans
SIZE: 44 lines, 8 variables
DESCRIPTIVE ABSTRACT:
Drug interaction study of a new and a standard oral contraceptive
therapy. See the "STORY BEHIND THE DATA" and "PEDAGOGICAL NOTES"
sections below for details.
SOURCES:
Bradstreet, T. E. (1991), "Some Favorite Data Sets from Early Phases
of Drug Research," in _Proceedings of the Section on Statistical
Education, American Statistical Association_, pp. 190-195.
Bradstreet, T. E. (1992), "Favorite Data Sets from Early Phases of
Drug Research - Part 2," in _Proceedings of the Section on
Statistical Education, American Statistical Association_, pp. 219-223.
Bradstreet, T. E. 1994), "Favorite Data Sets from Early Phases of
Drug Research - Part 3," in _Proceedings of the Section on Statistical
Education, American Statistical Association_, pp. 247-252.
Bradstreet, T. E., and Liss, C. L. (1995), "Favorite Data Sets from Early
(and Late) Phases of Drug Research - Part 4," in _Proceedings of the
Section on Statistical Education, American Statistical Association_,
pp. 335-340.
Bradstreet, T. E., and Short, T. H. (2001), "Favorite Data Sets From
Early Phases of Drug Research - Part 5, "in _Proceedings of the
Section on Statistics Education, American Statistical Association_,
CD-ROM.
VARIABLE DESCRIPTIONS:
Columns Description
1-2 Female Subject Number (1 to 22)
4 Treatment Sequence (1 = Drug D, placebo; 2 = placebo,
Drug D)
6 Study Period (1, 2)
8 Treatment (0 = placebo, 1 = Drug D)
10-15 EE - AUC (pg*hr/ml)
17-19 EE - Cmax (pg/ml)
21-28 NET - AUC (pg*hr/ml)
30-34 NET - Cmax (pg/ml)
Values are delimited by blanks.
SPECIAL NOTES:
Twenty-eight other data sets and stories are available at the Web site
http://www.villanova.edu/~short/Bradstreet/.
STORY BEHIND THE DATA:
Twenty-two female subjects were allocated randomly to one of two
treatment sequences in a two period crossover design. The two
treatments were a new Drug D or placebo, both given concomitantly with
a standard oral contraceptive which was given in both study periods.
The oral contraceptive has two components - ethinyl estradiol (EE) and
norethindrone (NET). The purpose of the study was to evaluate whether
the presence of Drug D affected the bioavailability of each of the oral
contraceptive components.
PEDAGOGICAL NOTES:
This article focuses on a two treatment, two period, two treatment
sequence crossover drug interaction study of a new drug and a standard
oral contraceptive therapy. Both normal theory and distribution-free
statistical analyses are provided along with a notable amount of
graphical insight into the data set. For one of the variables, depending
on which analysis is favored, the decision on the presence or absence of
a drug interaction is reversed. The data also contain statistically
significant period effects; statistically significant but clinically
unimportant treatment effects; some modest degree of structural
nonnormality; and modest to more extreme outliers.
This data set can be used in relatively sophisticated statistics courses
which emphasize either biostatistics, statistical methods in clinical
trials, data analysis, or experimental design. The subject matter is of
interest and is accessible to faculty, and both statistics and
nonstatistics students. The level of study detail and statistical analyses
which should be transferred to the classroom is dependent upon the students'
needs, for example more detail and more sophisticated statistical analyses
and diagnostic work for graduate level biostatistics or statistics students;
and less detail and less sophisticated statistical analyses and diagnostic
work for undergraduate service course students.
This and 28 other pedagogically useful data sets can be found at
http://www.villanova.edu/~tshort/Bradstreet/.
SUBMITTED BY:
Thomas E. Bradstreet
Merck Research Laboratories
10 Sentry Parkway
Blue Bell, PA 19422
USA
thomas_bradstreet@merck.com
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