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Kao-Tai Tsai

Celgene Corporation



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88 – Topics in Clinical Trials 2

Analysis of Response Profiles of Clinical Trial Data

Sponsor: Biopharmaceutical Section
Keywords: Response Profile, GEE, Multidimensional Scaling, Clinical Trials

Kao-Tai Tsai

Celgene Corporation

Majority of clinical trial data analyses focus only on the last response of a patient and paying little attention to the responses before that. However, analysis of the response profile longitudinally can help to understand how the treatment works during the course of the treatments. In medical research with dynamic treatment allocation designs, patients' responses are tracked at every cycle or visit so that the proper treatment can be assigned for the next cycle of the trial. Therefore, it is crucial to extend the conventional data analysis to cover a broader scope so that the analytical results can be more informative to the clinical communities and the patients. We provide a case study of clinical trial data examining the whole response profile of each patient and trying to investigate the potential linkage of the responses with clinical factors and patient's background data.

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