Phase 2 and 3 Combination Designs to Accelerate Drug Development
- 1 June 2005
- journal article
- Published by Taylor & Francis in Journal of the American Statistical Association
- Vol. 100 (470) , 493-502
- https://doi.org/10.1198/016214504000001790
Abstract
For late-stage clinical development, we propose combining phase 2 and 3 trials via a two-stage adaptive design. In the first stage, short-term safety and efficacy are examined, after which low dose...Keywords
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