Seamless phase 2/3 combination designs (or phase 2/3 designs) hold great promise to bring optimal treatment to patients early and more efficiently. The concept is to combine traditional phase 2 and phase 3 trials seamlessly in operation and inferentially in statistical analysis. As phase 2/3 designs cover a large area of clinical applications, it is not possible to provide comprehensive details for all different clinical applications in this article.
Critical Path Initiative >>>>>>>>>>> Calls for “New tools to get fundamentally better answers about the safety and effectiveness of new products can be demonstrated, —in faster time frames, —with more certainty, —and at lower costs” Seamless Phase II/III designs offer great potential for achieving these objectives
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