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A Hybrid Phase I-II/III Clinical Trial Design Allowing Dose Re-Optimization in Phase III
Conventionally, evaluation of a new drug, A, is done in three phases. Phase I is based on toxicity to determine a “maximum tolerable dose” (MTD) of A, phase II is conducted to decide whether A at the MTD is promising in terms of response probability, and if so a large randomized phase III trial is c...
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| Publicado no: | Biometrics |
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| Main Authors: | , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
2019
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC6486466/ https://ncbi.nlm.nih.gov/pubmed/30367457 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/biom.12994 |
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