EVALUATION OF STATISTICAL METHODS FOR ANALYSIS OF SMALL-SAMPLE LONGITUDINAL CLINICAL TRIALS WITH DROPOUTS

    • Abe Takayuki
    • Biostatistics & Research Decision Sciences, Banyu Pharmaceutical Co., Ltd.
    • Iwasaki Manabu
    • Department of Computer and Information Science, Seikei University

抄録

In longitudinal clinical trials that compare treatments of chronic diseases missing data occur mainly because of dropouts, where patients stop participating in the trial before the completion due to various reasons. Such incomplete data are often analyzed by using so-called completer analysis and/or LOCF (Last Observation Carried Forward). However, such procedures require strong assumptions for their validity. Multiple imputation (MI) (Rubin, 1987) is a valid method under MAR (Missing At Random). This method consists of three steps ("imputation", "analysis" and "combination") and various methods for MI also have been proposed. In this paper, we evaluate the performance of four methods for MI contrasted with completer analysis and LOCF via Monte-Carlo simulations in the context of small-sample longitudinal clinical trials for comparison of two treatments. The performance of these methods with non-normal data (i.e. mixture of responders and non-responders) is also examined.

収録刊行物

Journal of the Japanese Society of Computational Statistics   [巻号一覧]

Journal of the Japanese Society of Computational Statistics 20(1), 1-18, 2007-12  [この号の目次]

日本計算機統計学会

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各種コード

  • NII論文ID(NAID) :
    110006684309
  • NII書誌ID(NCID) :
    AA10823693
  • 本文言語コード :
    ENG
  • 資料種別 :
    ART
  • ISSN :
    09152350
  • 収録DB :
    CJP書誌  NII-ELS