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- W4248176470 abstract "At its core, a clinical trial is designed to test a specific primary hypothesis. The primary efficacy endpoint in a clinical trial is a clinical or laboratory outcome measured in an individual after randomization that allows one to test the primary hypothesis and provides the means of assessing whether a therapy is effective compared with its control. A primary endpoint can be measured once or repeatedly over time, or may comprise several kinds of individual measurements. Once a primary endpoint is selected, statistical methods of analysis to test the primary hypothesis can be determined and sample size calculations can be performed to ensure the trial is properly powered. Because of the key role of the primary endpoint in the design and analysis of a trial, it is critical that it be chosen carefully. A primary efficacy endpoint must be precisely specified in advance and should (1) address the primary objective, (2) be ascertainable in all patients, (3) be “fair” to each study arm, (4) have demonstrated or accepted relevance for the population and intervention(s) of the trial, and (5) be sensitive to meaningful changes in a patient's health." @default.
- W4248176470 created "2022-05-12" @default.
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- W4248176470 date "2014-09-29" @default.
- W4248176470 modified "2023-09-30" @default.
- W4248176470 title "Primary Efficacy Endpoint" @default.
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- W4248176470 doi "https://doi.org/10.1002/9781118445112.stat07126" @default.
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