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Cross-Over Trials Should Not be Used to Test Treatments with Different Chemical Class

In: Statistics Applied to Clinical Trials

Author

Listed:
  • Ton J. Cleophas

    (European Interuniversity College of Pharmaceutical Medicine Lyon
    Albert Schweitzer Hospital, Department Medicine)

  • Aeilko H. Zwinderman

    (Academic Medical Center Amsterdam, Department Biostatistics and Epidemiology)

  • Toine F. Cleophas

    (Technical University)

Abstract

So many unpredictable variables often play a role in clinical trials of new medical treatments that a trial without controls has become almost unconceivable. Usually, a parallel-group design is used: with every patient given a new therapy, a control patient is given standard therapy or a placebo. For the study of reversible treatments of chronic stable conditions with responses that can be measured on relatively short notice a cross-over design can be chosen: a single patient receives both new therapy and a standard therapy or placebo. Of course, we have to be fairly sure that carryover effects of one treatment period carrying on into the other or time effects are negligible. But then the cross-over design has the advantage that it eliminates between-subject variability of symptoms in a treatment comparison. And this makes the design sensitive, particularly with conditions where between-subject variability is notoriously large, e.g., angina pectoris and many other pain syndromes.

Suggested Citation

  • Ton J. Cleophas & Aeilko H. Zwinderman & Toine F. Cleophas, 2006. "Cross-Over Trials Should Not be Used to Test Treatments with Different Chemical Class," Springer Books, in: Statistics Applied to Clinical Trials, chapter 0, pages 239-248, Springer.
  • Handle: RePEc:spr:sprchp:978-1-4020-4650-6_21
    DOI: 10.1007/978-1-4020-4650-6_21
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