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- W1497474955 abstract "Phase II trials have two aims: (1) to provide a proof of concept that the drug is able to affect the disease it is designed to affect without overt safety problems and (2) to define the dose(s) to be taken forward to phase III. Trials that specifically address these issues are often referred to as phase IIa and phase IIb trials, respectively. Therefore, phase II trials provide the initial test of efficacy and reassurance on safety in patients and, if successful, define the dose or doses to be carried forward to be studied in the wider populations and longer-term phase III trials.Keywords:Phase II trial;dose response;proof of concept" @default.
- W1497474955 created "2016-06-24" @default.
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- W1497474955 date "2014-09-29" @default.
- W1497474955 modified "2023-09-27" @default.
- W1497474955 title "Phase II Trials" @default.
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- W1497474955 doi "https://doi.org/10.1002/9781118445112.stat07103" @default.
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