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Activity Number: 646
Type: Contributed
Date/Time: Thursday, August 7, 2014 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #313461
Title: Planning Sample Size Using MMRM in Presence of Missing Data
Author(s): Tao Song*+ and Ying Zhu and Pamela Hsu and Gajanan Bhat
Companies: Spectrum Pharmaceutical and Biogen Idec and Spectrum Pharmaceutical and Spectrum Pharmaceutical
Keywords: Sample size estimation ; MMRM ; Missing data
Abstract:

When planning sample size in clinical study protocol, the sample size is estimated from hypothesized effect size of the underlying study treatment. In order to account for potential dropout during the study, it is not uncommon to ignore the data for subjects who drop out of the study before the primary endpoint is reached. So the resulting sample size in the study may be larger than necessary, in particular when dropout rate is large (eg, 30%) and such data can be appropriately used in the actual analysis(eg, MMRM). We will present a simulation study that quantifies how much these dropout subjects can contribute to the study power, and thus help clinical trialists to better plan sample size at study design stage.


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