volume 14, issue 1, P1-6 2018
DOI: 10.1177/1747016118764304
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Abstract: A non-inferiority design accepts the possibility of some efficacy loss, as part of a "successful", statistically significant result. That loss may be excessive when the non-inferiority threshold is lenient. However, even stringent significance thresholds and safety monitoring may fail to adequately protect study participants when the primary outcome is death. The OPTIMAAL trial, a large randomized clinical trial performed in high-risk patients, is discussed as an example, using the Belmont Report principles as…

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