03965nam a22005655i 4500 978-3-031-65948-5 DE-He213 20251030114638.0 cr nn 008mamaa 241225s2024 sz | s |||| 0|eng d 9783031659485 978-3-031-65948-5 10.1007/978-3-031-65948-5 doi QH323.5 PBT bicssc MED090000 bisacsh PBT thema Biostatistics in Biopharmaceutical Research and Development [electronic resource] : Clinical Trial Design, Volume 1 / edited by Ding-Geng Chen. 1st ed. 2024. Cham : Springer Nature Switzerland : Imprint: Springer, 2024. XXIV, 344 p. 118 illus. online resource. text txt rdacontent computer c rdamedia online resource cr rdacarrier text file PDF rda Bias and Randomization in Clinical Trials: 1980s – 2020s – 2060s -- The Markov Model for Survival Trials at 35 Years-Old -- Absolute Power Corrupts Absolutely: A Review of the Use of Unconditional Probabilities in the Planning of Clinical Trials -- Design of Clinical Trials with the Desirability of Outcome Ranking Methodology -- Benefit:Risk Assessments during Clinical Trials: A Prediction Approach Using the Desirability of Outcome Ranking (DOOR) -- The Power of Integration: How the 2-in-1 Clinical Trial Design is Changing the Future of Drug Development -- A Unified Bayesian Decision Rule-Based Approach for Bayesian Design of Clinical Trials Using Historical Data -- Group Sequential Design Under Non-proportional Hazards: Methodologies and Examples -- Multiple Testing in Group Sequential Design -- Plan per-protocol (PP) causal inference analysis addressing intercurrent events following the targeted learning roadmap -- Maximum Tolerated Imbalance Randomization: Theory and Practice -- Response-adaptive randomization designs based on optimal allocation proportion. The Deming Conference on Applied Statistics has long been deemed an influential event in the biostatistics and biopharmaceutical profession. It provides learning experience on recent developments in statistical methodologies in biopharmaceutical applications and FDA regulations. This book honors 80 years of contributions and dedication of the Deming Conference in biostatistics, and biopharmaceutical clinical trial methodology and applications. All chapters are contributed by world-class and prominent Deming speakers, who've contributed their cutting-edge research and developments to the community. Volume 1 covers Historical Milestones in Clinical Trial Design, FDA biopharmaceutical design guidance, and emerging development in Clinical Trial Design Methodology. This book aims to booster research, education, and training in biostatistics and in biopharmaceutical research and development. Biometry. 65981 Clinical medicine Research. 74123 Public health. 61312 Sampling (Statistics). 59805 Data mining. 6941 Biostatistics. 65985 Clinical Research. 74124 Public Health. 61312 Survey Methodology. 74358 Data Mining and Knowledge Discovery. Chen, Ding-Geng. editor. edt http://id.loc.gov/vocabulary/relators/edt 80220 SpringerLink (Online service) Springer Nature eBook Printed edition: 9783031659478 Printed edition: 9783031659492 Printed edition: 9783031659508 https://doi.org/10.1007/978-3-031-65948-5 ZDB-2-SME ZDB-2-SXM 66021 66021