Design and Analysis of Bridging Studies (Chapman & Hall/CRC Biostatistics Series)

This book provides a comprehensive and unified summary of the growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology pertaining to the design and evaluation of bridging studies, which provide pharmacodynamic or clinical data that allow extrapolation of the foreign clinical data to a new region. Along with a thorough overview of bridging studies, the text addresses issues arising from bridging studies, including ethnic sensitivity, necessity of bridging studies, types of bridging studies, and assessment of similarity b. Read more... Content: 1. Bridging diversity : extrapolating foreign data to a new region / Shein-Chung Chow and Chin-Fu Hsiao -- 2. Two-stage designs of bridging studies / Chin-Fu Hsiao ... [et al.] -- 3. Consistency of treatment effects in bridging studies and global multiregional trials / Weichung J. Shih and Hui Quan -- 4. Assessing similarity using the reproducibility and generalizability probabilities and the sensitivity index / Shein-Chung Chow, Ying Lu, and Lan-Yan Yang -- 5. Combining information in clinical drug development : bridging studies and beyond / Kuang-Kuo Gordon Lan and Jose Pinheiro -- 6. A Bayesian approach for evaluation of bridging studies / Chin-Fu Hsiao ... [et al.] -- 7. Issues of sample size in bridging trials and global clinical trials / Hsien-Ming James Hung, Sue-Jane Wang, and Robert O'Neill -- 8. Design and sample size considerations for global trials / Christy Chuang-Stein ... [et al.] -- 9. Application of genomic technologies for bridging strategy involving different race and ethnicity in pharmacogenomics clinical trials / Sue-Jane Wang -- 10. Interaction effects in bridging studies / Eric Tsung-Cheng Hsieh and Jen-pei Liu -- 11. Multiregional clinical trials / Yi Tsong and Hsiao-Hui Tsou -- 12. Multiregional clinical trials for global simultaneous drug development in Japan / Kihito Takahashi, Mari Ikuta, and Hiromu Nakajima -- 13. Feasibility and implementation of bridging studies in Taiwan / Mey Wang, Yeong-Liang Lin, and Herng-Der Chern. Abstract: This book provides a comprehensive and unified summary of the growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology pertaining to the design and evaluation of bridging studies, which provide pharmacodynamic or clinical data that allow extrapolation of the foreign clinical data to a new region. Along with a thorough overview of bridging studies, the text addresses issues arising from bridging studies, including ethnic sensitivity, necessity of bridging studies, types of bridging studies, and assessment of similarity b "In recent years, the variations of pharmaceutical products in efficacy and safety among different geographic regions due to ethic factors is a matter of great concern for sponsors as well as for regulatory authorities. However, the key issues lie on when and how to address the geographic variations of efficacy and safety for the product development. To address this issue, a general framework has been provided by the ICH E5 (1998) in a document titled "Ethnic Factors in the Acceptability of Foreign Clinical Data" for evaluation of the impact of ethnic factors on the efficacy, safety, dosage, and dose regimen. The ICH E5 guideline provides regulatory strategies for minimizing duplication of clinical data and requirements for bridging evidence to extrapolate foreign clinical data to a new region. More specifically, the ICH E5 guideline suggests that a bridging study should be conducted in the new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage, and dose regimen to allow extrapolation of the foreign clinical data to the population of the new region. However, a bridging study may require significant development resources and also delay availability of the test medical product to the needed patients in the new region. To accelerate the development process and shorten approval time, the design of multiregional trials incorporates subjects from many countries around the world under the same protocol. After showing the overall efficacy of a drug in all global regions, one can also simultaneously evaluate the possibility of applying the overall trial results to all regions and subsequently support drug registration in each of them"--Provided by publisher. "In recent years, the variations of pharmaceutical products in efficacy and safety among different geographic regions due to ethic factors is a matter of great concern for sponsors as well as for regulatory authorities. However, the key issues lie on when and how to address the geographic variations of efficacy and safety for the product development. To address this issue, a general framework has been provided by the ICH E5 (1998) in a document titled "Ethnic Factors in the Acceptability of Foreign Clinical Data" for evaluation of the impact of ethnic factors on the efficacy, safety, dosage, and dose regimen. The ICH E5 guideline provides regulatory strategies for minimizing duplication of clinical data and requirements for bridging evidence to extrapolate foreign clinical data to a new region. More specifically, the ICH E5 guideline suggests that a bridging study should be conducted in the new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage, and dose regimen to allow extrapolation of the foreign clinical data to the population of the new region. However, a bridging study may require significant development resources and also delay availability of the test medical product to the needed patients in the new region. To accelerate the development process and shorten approval time, the design of multiregional trials incorporates subjects from many countries around the world under the same protocol. After showing the overall efficacy of a drug in all global regions, one can also simultaneously evaluate the possibility of applying the overall trial results to all regions and subsequently support drug registration in each of them"--Résumé de l'éditeur 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 w Taking into account the International Conference Harmonisation E5 framework for bridging studies, this book covers the regulatory requirements, scientific and practical issues, and statistical methodology for designing and evaluating bridging studies and multiregional clinical trials. For bridging studies, the authors explore ethnic sensitivity,