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341 – Daily Predictions of Key Estimates and Models to Detect Nonsampling Errors in Census Bureau Household Surveys
Seamless Phase IIa/IIb and Enhanced Dose Finding Adaptive Design
Jiacheng Yuan
Novartis
Herbert Pang
DU School of Medicine
Tiejun Tong
Hong Kong Baptist University
In drug development, when the product class has a relatively well defined path to market and the enrollment is slow with certain patient populations, one may want to consider combining studies of different phases. This paper considers combination of a proof of concept study and a dose finding (DF) study. Conventional DF study designs sometimes are not efficient, or don't have good chances to find the optimal doses for Phase III trials. This paper seeks more efficient DF approaches that allow economical testing of more doses. Hypothetical examples are simulated to compare the proposed adaptive design versus the conventional design based on assumed models of the overall quantitative representation of efficacy, safety and tolerance. The results show that the proposed adaptive design tests more active doses with higher actual power and comparable or smaller sample size in a shorter overall duration, compared to a conventional design.