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Activity Number:
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579
- Tests of Noninferiority in the Clinical Trial Setting
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Type:
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Contributed
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Date/Time:
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Wednesday, August 2, 2017 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #324048
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View Presentation
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Title:
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Non-Inferiority Trial Design by Considering Maximally/Minimally Observed Treatment Difference
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Author(s):
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Shufang Liu* and Misun Lee
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Companies:
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Astellas Pharma and Astellas Pharma
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Keywords:
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Non-inferiority ;
maximally observed difference ;
minimally observed difference
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Abstract:
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Non-inferiority (NI) clinical trials are conducted to compare the new treatment against an active control where placebo cannot be given due to ethical concerns. Increasing trend has shown with published results from NI clinical trials. The US Food and Drug (FDA) guidance on NI trials was finalized in year 2016. The guidance lays out the possible outcomes of a superiority trial and a non-inferiority trial. The NI clinical trials aim to demonstrate that the new treatment is not worse than the active control by more than an acceptable amount (M2). In addition to the margin M2, the non-inferiority trials have an inherent margin (0) for concluding either superiority or inferiority of the new treatment over the active control. In our presentation, we will introduce the concepts of maximally observed difference (MXOD) and minimally observed difference (MNOD) to better understand the potential outcomes at the study design stage. By considering MXOD and MNOD at the study design stage, we can minimize the probability of inconclusive results and explore the appropriate samples sizes.
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Authors who are presenting talks have a * after their name.
