A useful testing strategy in phase iii trials: combined test of superiority and test of equivalence
- 1 January 1995
- journal article
- research article
- Published by Taylor & Francis in Journal of Biopharmaceutical Statistics
- Vol. 5 (3) , 297-306
- https://doi.org/10.1080/10543409508835115
Abstract
A useful testing strategy is proposed for a confirmatory phase III clinical trial. It consists of a combined test of superiority and test of equivalence, and it is easy to apply. By introducing the strategy, we can perform a post hoc analysis in a confirmatory experiment. Thus a more flexible decision will be possible than the usual single testing method provides. It is shown that the procedure needs no adjustment for multiplicity from the point of view of the closed testing procedure. The relationship between this strategy and a confidence interval is also discussed.Keywords
This publication has 7 references indexed in Scilit:
- The use of one-sided tests in drug trials: an fda advisory committee member's perspectiveJournal of Biopharmaceutical Statistics, 1991
- One-sided and two-sided tests and ρ valuesJournal of Biopharmaceutical Statistics, 1991
- A comment concerning one-sided tests of significance in new drug applicationsJournal of Biopharmaceutical Statistics, 1991
- Some thoughts on the one-sided and two-sided testsJournal of Biopharmaceutical Statistics, 1991
- One-sided or two-sided ρ values: which most appropriately address the question of drug efficacy?Journal of Biopharmaceutical Statistics, 1991
- A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailabilityJournal of Pharmacokinetics and Biopharmaceutics, 1987
- On closed testing procedures with special reference to ordered analysis of varianceBiometrika, 1976