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Statistical vs Clinical Significance in Product Testing: Can They Be Designed to Satisfy Equivalence?
Author(s) -
Kingman Albert
Publication year - 1992
Publication title -
journal of public health dentistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.64
H-Index - 63
eISSN - 1752-7325
pISSN - 0022-4006
DOI - 10.1111/j.1752-7325.1992.tb02303.x
Subject(s) - equivalence (formal languages) , statistical analysis , product (mathematics) , statistical hypothesis testing , sample size determination , statistical significance , mathematics , computer science , statistical model , reliability engineering , statistics , engineering , pure mathematics , geometry
Statistical issues associated with demonstrating significance between treatment groups (efficacy or superiority) and nonsignificance (equivalence) are presented and discussed. Methodologies for demonstrating efficacy of a product are proposed and contrasted, incorporating clinical and statistical criteria, with emphasis on situations in which placebo groups are precluded from the study design. Distinctions are drawn between study designs for demonstrating superiority and those for equivalence, including the determination of sample sizes needed for the different approaches. The “at least as good as” criterion is proposed as a reasonable alternative to that of equivalence in active control equivalence studies for demonstrating that dental product modifications or new products are efficacious.