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Abstract:
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The clinical hypothesis of a clinical trial usually directs attention to assess efficacy endpoints solely at one specific timepoint of interest. To fully evaluate the relative benefits of investigating therapies or establish optimal treatment options, it would be of special interest to address the arising clinical question in regard to the overall treatment effects across multiple timepoints during the follow-up. The aggregated over-time evaluation will provide supportive scientific information for sponsor to strategize the critical decision making of drug development such as dose selection, bench marking an active control etc. To address the overall efficacy across multiple visits, we propose a global test in the paradigm of longitudinal data analysis to jointly assess treatment effects at multiple timepoints. The global test can be easily implemented using the SAS PROC MIXED/GLMMIX/GENMOD procedure with the CONTRAST statement. Example SAS codes are provided as the implementation guide. This work aims to shed light on the comparison of the overall profile of treatment effects over time, to inform a robust efficacy evaluation, and to further guide critical decision making in drug development.
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