• Statistics in medicine · Sep 1999

    Ignorability and bias in clinical trials.

    • D F Heitjan.
    • Division of Biostatistics, Columbia University School of Public Health, 600 W. 168th Street, New York, NY 10032, USA. dfh5@columbia.edu
    • Stat Med. 1999 Sep 15; 18 (17-18): 2421-34.

    AbstractPatient non-compliance and drop-out can bias analyses of clinical trial data. I describe a parametric model for treatment cross-over and drop-out and demonstrate how the concept of ignorability, originally defined for incomplete-data problems, can elucidate sources of bias in clinical trials. I discuss some implications of the theory and present simulation examples that illustrate the potential effects of non-ignorable cross-over and drop-out on bias and power.

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