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260 – Contributed Oral Poster Presentations: Section on Statistical Education
Assessing the Cumulative Exposure Response in Alzheimer's Disease Studies
Jianing Di
Janssen R&D
Xin Zhao
Janssen R&D
Daniel Wang
Janssen R&D
Ming Lu
Janssen R&D
Michael Krams
Janssen R&D
To assess long-term cumulative benefit of a treatment, the relationship between cumulative drug exposure and outcomes could be explored to understand dose response. However, cumulative exposure corresponds to the longitudinal profile of an outcome, which is heavily confounded with natural disease progression and missing data. A model-based approach is developed to account for the confounding factors. In particular, the observed measures are adjusted by the projected disease progression at the corresponding time points before exposure response is assessed. The proposed
approach introduces new insights to the interpretation of study data. In the case study used to demonstrate the method, there seem to be various degrees of efficacy trend favoring higher level of cumulative exposure in active drug, based on selected clinical and biomarker endpoints.