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Activity Number:
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505
- Missing Data and Multiple Imputation in Clinical Trials
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Type:
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Contributed
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Date/Time:
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Wednesday, August 2, 2017 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #324240
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View Presentation
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Title:
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A Practical Application of Multiple Imputation (MI) in a Double Blinded Randomized Phase III Study in Spinal Muscular Atrophy
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Author(s):
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Peng Sun* and Richard Foster and Guochen Song and John Zhong
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Companies:
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Biogen and Biogen and Biogen and Biogen
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Keywords:
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Multiple Imputation ;
SMA ;
Practical ;
Phase III ;
Application
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Abstract:
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In a double blinded randomized phase III study in subjects with later onset spinal muscular atrophy (SMA), MI was pre-specified as the primary method for handling missing data at both the interim and the final analyses. It was also planned that the interim analysis would be performed on the ITT Set thus necessitating imputation for all ongoing subjects. The advantages (such as the increased power at the interim analysis) and the challenges (such as choosing the optimal timing for interim analysis and method for determining the alpha level at the final analysis) will be discussed both based on simulated and actual trial data.
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Authors who are presenting talks have a * after their name.
