Equivalence in test assay method comparisons for the repeated-measure, matched-pair design in medical device studies: statistical considerations.
In medical device clinical studies, including therapeutic device and in vitro test assay method studies, the investigator is frequently interested in demonstrating the equivalence of clinical response, generally in continuous measurements, between a standard assay method and a new assay method over various occasions or times. The new assay method may be less invasive or more convenient or cheaper to use than the standard assay method. In this paper, several statistical approaches are discussed, including various repeated-measure regression models, the simultaneous 95% confidence interval for paired mean differences derived from Hotelling's multivariate T2 analysis for repeated-measure, paired data, repeatability and reproducibility studies, and concordance correlation coefficient.
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Center for Devices and Radiological Health, United States Food and Drug Administration, Rockville, Maryland 20850, USA.
D016001:Confidence Intervals; D004864:Equipment and Supplies / Q000592:standards*; D016018:Least-Squares Analysis; D016555:Matched-Pair Analysis; D015203:Reproducibility of Results; D012107:Research Design / Q000706:statistics & numerical data*