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The Two-Period Crossover Design in Medical Research
- John R. Woods, PhD;
- James G. Williams, MS; and
- Morton Tavel, MD
Abstract
The crossover design has enjoyed popularity with many clinical researchers, but has been criticized by biostatisticians. The central problem is the inability to derive an unbiased estimate of the treatment effect when differences occur because of the different sequences in which treatments are applied. This problem can be traced to a deficiency of the logic of the crossover arrangement itself. Factors that can invalidate the findings of a crossover trial include nonuniform pharmacologic and psychologic carry-over effects, failure to return patients to their baseline state before the crossover, nonuniform changes in the patients over time, and the use of time-dependent response measures. When these problems can be anticipated, a parallel-groups design should be used instead of a crossover trial.
Article and Author Information
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From Methodist Hospital of Indiana, Inc., Indianapolis, Indiana. For current author addresses, see end of text.
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Requests for Reprints: John R. Woods, PhD, Department of Medical Research, Methodist Hospital of Indiana, Inc., 1701 N. Senate Boulevard, Box 1367, Indianapolis, IN 46206.
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Current Author Addresses: Drs. Woods and Tavel: Department of Medical Research, Methodist Hospital of Indiana, Inc., Indianapolis, IN 46202.
Mr. Williams: Academic Computer Services, Indiana University-Purdue University at Indianapolis, Indianapolis, IN 46206.
