Challenges and regulatory experiences with non-inferiority trial design without placebo arm

For a non-inferiority trial without a placebo arm, the direct comparison between the test treatment and the selected positive control is in principle the only basis for statistical inference. Therefore, evaluating the test treatment relative to the non-existent placebo presents extreme challenges an...

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Bibliographic Details
Published in:Biometrical journal. Biometrische Zeitschrift, Vol. 51, No. 2 (2009), p. 324-34
Main Author: Hung, H M James
Other Involved Persons: Wang, Sue-Jane ; O'Neill, Robert
Format: electronic Article
Item Description:Date Completed 04.06.2009
Date Revised 13.04.2009
published: Print
Citation Status MEDLINE
Copyright: From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Physical Description:Online-Ressource
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