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Library | Item Barcode | Call Number | Material Type | Item Category 1 | Status |
|---|---|---|---|---|---|
Searching... | 30000010304249 | RM301.27 D47 2013 | Open Access Book | Book | Searching... |
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Summary
Summary
As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the world under the same protocol.
Design and Analysis of Bridging Studies addresses the issues arising from bridging studies and multiregional clinical trials. For bridging studies, the book explores ethnic sensitivity, the necessity of bridging studies, types of bridging studies, and the assessment of similarity between regions based on bridging evidence. For multiregional clinical trials, the text considers regional differences, assesses the consistency of treatment effect across regions, and discusses sample size determination for each region.
Taking into account the International Conference Harmonisation (ICH) E5 framework for bridging studies, the book provides a unified summary of the growing literature and research activities in this area. It covers the regulatory requirements, scientific and practical issues, and statistical methodology for designing and evaluating bridging studies and multiregional clinical trials, with the goal of inspiring new research activities in the field.
Author Notes
Jen-pei Liu is a professor in the Division of Biometry, Department of Agronomy, and Institute of Epidemiology and Preventative Medicine at National Taiwan University. He is also an adjunct investigator in the Institute of Population Health Sciences at the National Health Research Institutes in Taiwan. A fellow of the ASA, Dr. Liu is an associate editor of the Journal of Biopharmaceutical Statistics and an editor of the Chapman & Hall/CRC Biostatistics Series. He has authored ten books, over 120 peer-reviewed research articles, and over 40 book chapters. His research interests include statistical methodology in bioequivalence evaluation, clinical trials, equivalence and noninferiority testing, bridging testing, statistical quality control in biopharmaceutical products, diagnostic testing, statistical QA/QC for biochip diagnostic products, and evaluation of substantial equivalence in GMO crops and food.
Shein-Chung Chow is a professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. Dr. Chow is also a professor of clinical sciences at Duke-National University of Singapore Graduate Medical School. He is the editor-in-chief of the Journal of Biopharmaceutical Statistics and editor-in-chief of the Chapman & Hall/CRC Biostatistics Series. He has authored or co-authored over 200 papers and 19 books, including Adaptive Design Methods in Clinical Trials, Second Edition, Handbook of Adaptive Designs in Pharmaceutical and Clinical Development, and Controversial Statistical Issues in Clinical Trials. A fellow of the ASA and member of the ISI, Dr. Chow has received the ASA Chapter Service Recognition Award, the DIA Outstanding Service Award, and the ICSA Extraordinary Achievement Award.
Chin-Fu Hsiao is an investigator in the Institute of Population Health Sciences at the National Health Research Institutes in Taiwan. Dr. Hsiao is also an adjunct associate professor at National Chiao Tung University. His research interests encompass Bayesian analysis, clinical trials, and genetic study.
Table of Contents
| Bridging Diversity: Extrapolating Foreign Data to a New RegionShein-Chung Chow and Chin-Fu Hsiao |
| Introduction |
| Impact of Ethnic Differences |
| Regulatory Guidelines |
| Current Issues |
| Examples |
| Concluding Remarks |
| Aim and Structure of the Book |
| Two-Stage Designs of Bridging StudiesChin-Fu Hsiao and Hsiao-Hui Tsou and Jen-pei Liu and Yuh-Jenn Wu |
| Introduction |
| Two-Stage Design for Bridging Studies |
| Group Sequential Approach to Evaluating Bridging Studies |
| Concluding Remarks |
| Consistency of Treatment Effects in Bridging Studies and Global Multiregional TrialsWeichung J. Shih and Hui Quan |
| Introduction |
| Global Clinical Trial |
| Consistency in Making Inference Regarding the Overall Treatment Effect |
| Consistency as a Method for Region-Specific Registration |
| Other Considerations |
| Example |
| Discussion |
| Assessing Similarity Using the Reproducibility and Generalizability Probabilities and the Sensitivity IndexShein-Chung Chow and Ying Lu and Lan-Yan Yang |
| Introduction |
| Criteria for Assessing Similarity |
| Reproducibility and Generalizability |
| Assessing the Similarity-Based Sensitivity Index |
| Concluding Remarks |
| Combining Information in Clinical Drug Development: Bridging Studies and BeyondKuang-Kuo Gordon Lan and Jose Pinheiro |
| Introduction |
| Leveraging Existing Information in Bridging Studies |
| Application: Bridging of Blood Pressure Drug |
| Discussion |
| A Bayesian Approach for Evaluation of Bridging StudiesChin-Fu Hsiao and Hsiao-Hui Tsou and Jen-pei Liu and Yuh-Jenn Wu |
| Introduction |
| Mixture of Prior Information |
| Determination of Sample Size |
| Examples |
| Concluding Remarks |
| Issues of Sample Size in Bridging Trials and Global Clinical TrialsHsien-Ming James Hung and Sue-Jane Wang and Robert O'Neill |
| Issues of Sample Size Planning for Bridging Trial |
| Issues of Sample Size Planning in Global Clinical Trial |
| Impacts of Consistency Assessment on Sample Size |
| Discussion |
| Design and Sample Size Considerations for Global TrialsChristy Chuang-Stein and Yoichi Ii and Norisuke Kawai and Osamu Komiyama and Kazuhiko Kuribayashi |
| Introduction |
| Points to Consider When Designing a Multiregional Trial |
| Determination of Regional Sample Size in a Multiregional Study |
| Additional Analysis to Estimate Treatment Effects in Different Regions |
| Real-Time Monitoring of Multiregional Trials |
| Concluding Remarks |
| Application of Genomic Technologies for Bridging Strategy Involving Different Race and Ethnicity in Pharmacogenomics Clinical TrialsSue-Jane Wang |
| Introduction |
| Pharmacogenomics and Pharmacogenetics |
| Bridging |
| Bridging Study Evaluation |
| Challenges of Bridging Strategy in Pharmacogenomics |
| Concluding Remarks |
| Interaction Effects in Bridging StudiesEric Tsung-Cheng Hsieh and Jen-pei Liu |
| Introduction |
| Noninferiority Hypothesis for Treatment Similarity |
| Statistical Testing Procedures |
| Simulation Studies |
| Numerical Examples |
| Discussion and Final Remarks |
| Multiregional Clinical TrialsYi Tsong and Hsiao-Hui Tsou |
| Introduction |
| Different Regional Requirements |
| Bridging the Overall Treatment Effect to Regions |
| Summary |
| Multiregional Clinical Trials for Global Simultaneous Drug Development in JapanKihito Takahashi and Mari Ikuta and Hiromu Nakajima |
| Introduction |
| Drug Lag |
| MRCTs as a Solution to Drug Lag |
| Improvements in Clinical Trial Environment in Japan |
| Growing Trends of MRCTs in Japan |
| MRCTs in the Field of Oncology |
| MRCTs in the Field of CVM |
| Issues in MRCTs |
| Future Prospects |
| Feasibility and Implementation of Bridging Studies in TaiwanMey Wang and Yeong-Liang Lin and Herng-Der Chern |
| Overview |
| Regulatory History of Bridging Strategy |
| Assessment Experiences Based on ICH E5 |
| Bayesian Statistical Approach to Bridging Studies |
| Designing an External (Supplemental) Bridging Study |
| Concluding Remarks |
| Index |
| References appear at the end of each chapter |
