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SEQUENTIAL DESIGNS FOR EQUIVALENCE STUDIES
Author(s) -
WHITEHEAD JOHN
Publication year - 1996
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/(sici)1097-0258(19961230)15:24<2703::aid-sim536>3.0.co;2-v
Subject(s) - equivalence (formal languages) , bioequivalence , sequential analysis , computer science , clinical trial , context (archaeology) , medicine , mathematics , medical physics , statistics , pharmacology , paleontology , discrete mathematics , pathology , biology , bioavailability
Sequential designs are increasingly being used in major clinical trials concerning life‐threatening diseases. So far most applications have concerned trials designed to establish whether an experimental treatment is superior to a control. However, many trials are conducted with the objective of showing that an experimental treatment is equivalent to a control. This paper concerns the application of sequential designs to equivalence trials. Criteria for claiming equivalence are reviewed and compared, and methods first developed in the context of bioequivalence are described. Appropriate sequential procedures are identified. A simulated example, based on a clinical comparison of bronchodilators, is used to illustrate both the double triangular test and a comparable procedure constructed from α‐spending functions.