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Two-stage randomization designs in drug development.

Abstract:

One challenge in oncology drug development is to determine whether a new agent to the care of patients should be added concurrently as a new component to standard of care (SOC) induction treatment, used sequentially as an extended maintenance treatment after SOC induction for patients responding to induction therapy, or used in both the induction and the maintenance settings. A two-stage randomization design (TSRD) addresses these questions simultaneously. In such trials patients are initiall...

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Publication status:
Published

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Publisher copy:
10.1002/sim.3309

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Institution:
University of Oxford
Department:
Oxford, MSD, Clinical Medicine, Tropical Medicine
Role:
Author
Journal:
Statistics in medicine
Volume:
27
Issue:
21
Pages:
4161-4174
Publication date:
2008-09-05
DOI:
EISSN:
1097-0258
ISSN:
0277-6715
URN:
uuid:778e4b80-b358-40f6-aeb3-b03843386b38
Source identifiers:
113060
Local pid:
pubs:113060

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