Methodological developments vs. regulatory requirements |
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| Authors: | Bauer Peter |
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| Affiliation: | Core Unit for Medical Statistics and Informatics, Section of Medical Statistics, Medical University of Vienna, Spitalgasse 23, 1090 Vienna, Austria. peter.bauer@meduniwien.ac.at |
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| Abstract: | ![]()
This is a discussion of the following three papers appearing in this special issue on adaptive designs: 'FDA's critical path initiative: A perspective on contributions of biostatistics' by Robert T. O'Neill, 'A regulatory view on adaptive/flexible clinical trial design' by H. M. James Hung, Robert T. O'Neill, Sue-Jane Wang and John Lawrence; and 'Confirmatory clinical trials with an adaptive design' by Armin Koch. |
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