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Traditional efficacy interim design is based on alpha spending which does not have intuitive interpretation and hence is difficult to communicate with non-statistician colleagues. The alpha-spending approach is based on efficacy alone and hence does not have the flexibility to incorporate newly emerged safety signals. Newly emerged safety signals may nullify the originally set efficacy boundary. In contrast, the probability of success (POS) concept has an intuitive interpretation and hence can facilitate communication with non-statistician colleagues and help to obtain Health Authority (HA) buy in. The POS success criteria are not restricted to statistical significance. Hence, POS has the capability to incorporate both efficacy and safety information. We propose to use POS and its credible interval to design efficacy interim. In the proposed method, the efficacy boundary is adjustable to offset newly emerged safety signal.
The support of this presentation was provided by AbbVie. AbbVie participated in the review and approval of the content.
Zhongwen Tang is an employee of AbbVie Inc
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