Alternative Clinical Trial Designs and Methods for Assessing Treatment Effects Incorporating Real-World Data - Juniper Publishers

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Biostatistics and Biometrics - Juniper Publishers Abstract Traditional parallel group double-blind controlled trial design is the preferred approach to provide substantial evidence to support a new drug application. To elevate trial efficiency to a new level, the pharmaceutical industry and the health regulatory authorities continuously make great effort to propose the applications of innovative designs to new drug developments. These designs include the branching out group sequential desi