Abstract
As discussed in Chapter 1, the main purpose of Phase II studies is dose finding and most of these studies are designed to help estimate the dose–response relationships. On the other hand, Phase III studies are designed to confirm findings from early phases, and results from Phase III studies are used for submission to regulatory agencies for drug approval. Hence, Phase III studies are designed for decision making. In terms of hypotheses testing, ways of controlling the familywise error rate (FWER) strongly should be well specified prior to unmasking the study data. In many cases, these prespecification need to be clearly communicated with regulatory agencies for mutual agreement.
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Ling, X., Hsu, J., Ting, N. (2006). Partitioning Tests in Dose–Response Studies with Binary Outcomes. In: Ting, N. (eds) Dose Finding in Drug Development. Statistics for Biology and Health. Springer, New York, NY. https://doi.org/10.1007/0-387-33706-7_12
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DOI: https://doi.org/10.1007/0-387-33706-7_12
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