Abstract:
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Durability is the measure of the maintenance of therapeutic goal following the initial achievement of it in clinical trials. It measures the velocity of patients moving away from therapeutic effect. Superior durability keeps patients at treatment goal, delays the need to intensify therapy, and delays the onset of disease complications. Usually the durability of a therapy is the key driver for the long term outcomes in health economics model. Traditional durability analyses only include subjects who achieved therapeutic goals, and/or only including the time period after the time of achieving sufficient therapeutic effect. These analyses methods are generally not acceptable to regulatory agencies for labeling purpose, since the patient populations are no longer randomized populations, ie, it is not an intent-to-treat analysis. This presentation will illustrate a new analysis method which includes data from all randomized subjects and entire study treatment period, to satisfy the ITT principle and health authorities. A case study of application in diabetic therapies will be presented, and simulation results conducted for the comparisons of statistical power and type 1 error rate will
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