Comment
. 2006 Aug;48(4):609-12; discussion 613-22.
doi: 10.1002/bimj.200610244.
Methodological developments vs. regulatory requirements
Affiliations
- PMID: 16972713
- DOI: 10.1002/bimj.200610244
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Comment
Methodological developments vs. regulatory requirements
Biom J.
2006 Aug.
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.
Comment on
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FDA's critical path initiative: a perspective on contributions of biostatistics.Biom J. 2006 Aug;48(4):559-64. doi: 10.1002/bimj.200510237. Biom J. 2006. PMID: 16972706
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A regulatory view on adaptive/flexible clinical trial design.Biom J. 2006 Aug;48(4):565-73. doi: 10.1002/bimj.200610229. Biom J. 2006. PMID: 16972707
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Confirmatory clinical trials with an adaptive design.Biom J. 2006 Aug;48(4):574-85. doi: 10.1002/bimj.200510239. Biom J. 2006. PMID: 16972708
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