Design and analysis of bridging studies. (2012)

• Record Type: Book
• Further Information: Note: Edited by Jen-pei Liu, Shein-Chung Chow, Chin-Fu Hsiao.
• Other Names: Hsiao, Chin-Fu; Liu, Jen-pei, 1952-; Chow, Shein-Chung, 1955-
• Contents: Bridging Diversity: Extrapolating Foreign Data to a New Region, Shein-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 Studies, Chin-Fu Hsiao, Hsiao-Hui Tsou, 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 Trials, Weichung J. Shih and Hui Quan ; Introduction; Global Clinical Trial; Consistency in Making Inference Regarding the Overall Treatment Effect θ; Consistency as a Method for Region-Specific Registration; Other Considerations; Example; Discussion Assessing Similarity Using the Reproducibility and Generalizability Probabilities and the Sensitivity Index, Shein-Chung Chow, 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 Beyond, Kuang-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 Studies, Chin-Fu Hsiao, Hsiao-Hui Tsou, 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 Trials, Hsien-Ming James Hung, 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 Trials, Christy Chuang-Stein, Yoichi Ii, Norisuke Kawai, 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 Trials, Sue-Jane Wang ; Introduction; Pharmacogenomics and Pharmacogenetics; Bridging; Bridging Study Evaluation; Challenges of Bridging Strategy in Pharmacogenomics; Concluding Remarks Interaction Effects in Bridging Studies, Eric 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 Trials, Yi 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 Japan, Kihito Takahashi, 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 Taiwan, Mey Wang, 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.
• Publisher Details: Place of publication not identified : Chapman and Hall/CRC
• Publication Date: 2012
• Extent: 1 online resource, illustrations
• Subjects: 615.10727; Drugs -- Testing -- Statistical methods; Pharmacy -- Research -- Statistical methods; Drug development -- Statistical methods
• Languages: English
• ISBNs: 9781439846353; 1439846359
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.