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Tag Archives: noninferiority trials
New Draft Guidance on Noninferiority Trials
In March 2010, the FDA issued a draft guidance on the use of noninferiority (NI) trials. While not in final form, this guidance should help sponsors understand the issues the FDA considers when reviewing NI trials. In contrast to statements … Continue reading
Posted in FDA
Tagged clinical trials, efficacy, FDA, guidance, noninferiority trials, statistical analysis
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