Biopharmaceutical Applied Statistics Symposium

Volume 1 Design of Clinical Trials

Karl E. Peace, Ding-Geng (Din) Chen, Sandeep M. Menon (Herausgeber)

Buch | Hardcover

409 Seiten

2018 | 1st ed. 2018
Springer Verlag, Singapore
978-981-10-7828-6 (ISBN)

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This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments – particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter.The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications. This book is the first of the 3-volumebook series. The topics covered include: A Statistical Approach to Clinical Trial Simulations, Comparison of Statistical Analysis Methods Using Modeling and Simulation for Optimal Protocol Design, Adaptive Trial Design in Clinical Research, Best Practices and Recommendations for Trial Simulations in the Context of Designing Adaptive Clinical Trials, Designing and Analyzing Recurrent Event Data Trials, Bayesian Methodologies for Response-Adaptive Allocation, Addressing High Placebo Response in Neuroscience Clinical Trials, Phase I Cancer Clinical Trial Design: Single and Combination Agents, Sample Size and Power for the Mixed Linear Model, Crossover Designs in Clinical Trials, Data Monitoring: Structure for Clinical Trials and Sequential Monitoring Procedures, Design and Data Analysis for Multiregional Clinical Trials – Theory and Practice, Adaptive Group-Sequential Multi-regional Outcome Studies in Vaccines, Development and Validation of Patient-reported Outcomes, Interim Analysis of Survival Trials: Group Sequential Analyses, and Conditional Power – A Non-proportional Hazards Perspective.

1. A Statistical Approach to Clinical Trial Simulations.- 2. Comparison of Statistical Analysis Methods Using Modeling and Simulation for Optimal Protocol Design.- 3. Adaptive Trial Design in Clinical Research.- 4. Best Practices and Recommendations for Trial Simulations Within the Context of Designing Adaptive Clinical Trials.- 5. Designing and Analyzing Recurrent Event Data Trials.- 6. Bayesian Methodologies for Response-Adaptive Allocation.- 7. Addressing High Placebo Response in Neuroscience Clinical Trials.- 8. Phase I Cancer Clinical Trial Design: Single and Combination Agents.- 9. Sample Size and Power for the Mixed Linear Model.- 10. Crossover Designs.- 11. Data monitoring: Structure for Clinical Trials and Sequential Monitoring Procedures.- 12. Design and Data Analysis of Multiregional Clinical Trials (MRCT) – Theory and Practice.- 13. Multiregional Clinical Trials (MRCT).- 14. Adaptive Group-Sequential Multi-regional Outcome Studies in Vaccines.- 15. Development and validation of Patient-reported Outcomes.- 16. Interim Analysis of Survival Trials: Group Sequential Analyses and Conditional Power.

Erscheinungsdatum	07.04.2018
Reihe/Serie	ICSA Book Series in Statistics
Zusatzinfo	28 Illustrations, color; 26 Illustrations, black and white; XIV, 409 p. 54 illus., 28 illus. in color.
Verlagsort	Singapore
Sprache	englisch
Maße	155 x 235 mm
Themenwelt	Mathematik / Informatik ► Mathematik ► Statistik
	Mathematik / Informatik ► Mathematik ► Wahrscheinlichkeit / Kombinatorik
	Studium ► Querschnittsbereiche ► Epidemiologie / Med. Biometrie
	Naturwissenschaften ► Biologie
Schlagworte	Clinical Trial Simulations • data monitoring • Group Sequential Analyses • Multiregional Clinical Trials • Neuroscience Clinical Trials • Optimal Protocol Design • Phase I Cancer Clinical Trial Design • Recurrent Event Data Trials • Response-Adaptive Allocation • Statistical Analysis
ISBN-10	981-10-7828-9 / 9811078289
ISBN-13	978-981-10-7828-6 / 9789811078286
Zustand	Neuware