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[Statistical standards for clinical long-term studies].

M Schemper, V Scheiber

    Wiener Klinische Wochenschrift
    |May 11, 1984
    PubMed
    Summary
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    This paper outlines essential biometric standards for conducting authoritative long-term clinical studies in Austria. It emphasizes planning, randomization, and statistical collaboration for international acceptance.

    Area of Science:

    • Biostatistics
    • Clinical Trial Methodology

    Context:

    • Growing interest in long-term clinical studies in Austria.
    • Need for internationally accepted biometric standards.

    Purpose:

    • To detail essential biometric standards for long-term clinical studies.
    • To guide planning, implementation, and reporting phases.

    Summary:

    • Focuses on planning, random sampling, randomization, documentation, organization, and study termination.
    • Discusses multicenter investigations and the crucial role of biostatisticians.
    • Presents computer-aided and non-computer-aided methodologies.

    Impact:

    • Aims to enhance the authority and international acceptance of Austrian clinical studies.

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  • Facilitates collaboration between clinicians and biostatisticians.
  • Provides a methodological framework for rigorous study design and execution.