Titlebook: Biopharmaceutical Applied Statistics Symposium; Volume 3 Pharmaceuti Karl E. Peace,Ding-Geng Chen,Sandeep Menon Book 2018 Springer Nature S

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Interesting Applications from Three Decades of Biostatistical Consulting,d later dose discrimination, as well as illustrating the need to carefully define the trial objective. The last example provides an overview of assessing whether evidence exists from two Phase II trials of angina to support conducting a Phase III trial at either a b.i.d. or t.i.d. drug.

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Overview of Omics Biomarker Discovery and Design Considerations for Biomarker-Informed Clinical Trih-throughput omics technologies has enabled scientists to discover new biomarkers with low cost. Leveraging available technology and biomarker information, novel biomarker-based clinical trial designs have been proposed and have proven beneficial to many clinical programs. In this chapter, we discus

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Phase 3 Oncology Trials of Personalized Medicines with Adaptive Subpopulation Selection,ever, there is great uncertainty about drug activity in a subpopulation when designing a confirmatory trial in practice and it is logical to take a two-stage adaptive approach. The first stage de-selects (or prunes) non-performing subpopulations at an interim analysis, and the second stage pools the

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,Synergy or Additivity—The Importance of Defining the Primary Endpoint and the Approach to Its Statio therapeutic agents depends to a critical degree on how “synergy” is defined and how the data are analyzed. To illustrate these points, a hypothetical example based on an actual case is discussed. In the example, a common set of clinical trials was analyzed by two different organizations with two d

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Recycling of Significance Levels in Testing Multiple Hypotheses of Confirmatory Clinical Trials, types and sometimes into other lower types. The primary hypotheses enjoy a special status; if the trial wins for one or more primary hypotheses, then one can characterize clinically relevant benefits of the study treatment. This framework of classifying hypotheses based on their importance into pri