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Current Advanced Statistical Issues in Clinical Research—Adaptive Designs and Translational Medicine
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Chin-Fu Hsiao,
Tsang-Wu Walter Liu,
Chih-Hsin James Yang
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S1-S2
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A Regulatory View of Adaptive Trial Design
Developing a new medicine is an expensive and time-consuming process. Researchers are interested in applying better designs to expedite the approval of potential medicinal products. Adaptive designs, ...
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Mey Wang,
Ya-Chi Wu,
Guei-Feng Tsai
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S3-S8
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The Significance of Adaptive Design in R&D in Japan
In the past decade, the number of drug and biological product submissions to the United States Food and Drug Administration has been slowly declining, while biomedical research spending has increased....
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Masahiro Takeuchi
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S9-S13
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Considerations in Adapting Clinical Trial Design
The concept of adaptation of trial design during the course of a clinical trial has recently drawn much interest from the pharmaceutical industry. The interest arises partly because statistical decisi...
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H.M. James Hung
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S14-S18
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Utility of Adaptive Strategy and Adaptive Design for Biomarker-facilitated Patient Selection in Pharmacogenomic or Pharmacogenetic Clinical Development Program
In the early to late phases of conventional clinical trials, improvement of disease status at study baseline is the anchor of an effective treatment measured by therapeutic response. These population-...
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Sue-Jane Wang
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S19-S27
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Statistical Evaluation of Quality Performance on Genomic Composite Biomarker Classifiers
Background/Purpose: After completion of the Human Genome Project, genomic composite biomarker classifiers (GCBCs) became available. However, quality performance of GCBCs varies. We propose statistical...
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Jen-Pei Liu,
Li-Tien Lu
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S28-S34
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Statistical Methods for Targeted Clinical Trials under Enrichment Design
Background/Purpose: After completion of the Human Genome Project, disease targets at the molecular level can be identified. Treatment for these specific targets can be developed with the individualize...
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Jen-Pei Liu,
Jr-Rung Lin
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S35-S42
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Statistical Tests for One-way/Two-way Translation in Translational Medicine
Translational medicine has been defined as bench-to-bedside research, where a basic laboratory discovery becomes applicable to the diagnosis, treatment or prevention of a specific disease, and is brou...
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Siu-Keung Tse,
Shein-Chung Chow,
Chunyan Yang
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S43-S51
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On Two-stage Seamless Adaptive Design in Clinical Trials
In recent years, the use of adaptive design methods in clinical research and development based on accrued data has become very popular because of its efficiency and flexibility in modifying trial and/...
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Shein-Chung Chow,
Yi-Hsuan Tu
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S52-S60
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Statistical Methods in Translational Medicine
This study focuses on strategies and statistical considerations for assessment of translation in language (e.g. translation of case report forms in multinational clinical trials), information (e.g. tr...
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Shein-Chung Chow,
Siu-Keung Tse,
Min Lin
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S61-S73
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Translation in Different Diagnostic Procedures—Traditional Chinese Medicine and Western Medicine
Recently, the modernization of traditional Chinese medicines (TCM) for treatment of patients with critical and/or life-threatening diseases has attracted much attention in the pharmaceutical industry....
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Chin-Fu Hsiao,
Hsiao-Hui Tsou,
Yuh-Jenn Wu,
Chien-Hsiung Lin,
Yeu-Jhy Chang
et al.
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S74-S85
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