Biostatistics in Biopharmaceutical Research and Development

• Titel: Biostatistics in Biopharmaceutical Research and Development
• Titelzusatz: Clinical Trial Analysis, Volume 2
• Mitwirkende: Chen, Ding-Geng [HerausgeberIn]
• Verf.angabe: edited by Ding-Geng Chen
• Ausgabe: 1st ed. 2024.
• Verlagsort: Cham
• Verlagsort: Cham
• Verlag: Springer Nature Switzerland
• Verlag: Imprint: Springer
• E-Jahr: 2024
• Jahr: 2024.
• Jahr: 2024.
• Umfang: 1 Online-Ressource(XVIII, 517 p. 168 illus.)
• ISBN: 978-3-031-65937-9
• DOI: doi:10.1007/978-3-031-65937-9
• Datenträger: Online-Ressource
• Sprache: eng
• Bibliogr. Hinweis: Erscheint auch als : Druck-Ausgabe
• Bibliogr. Hinweis: Erscheint auch als : Druck-Ausgabe
• Bibliogr. Hinweis: Erscheint auch als : Druck-Ausgabe
• K10plus-PPN: 1913346609
• K10plus-PPN:
  Universitätsbibliothek
• Lokale URL UB: Zum Volltext
• Lokale URL UB: Bibliothek der Medizinischen Fakultät Mannheim der Universität Heidelberg
• Bibliothek/Idn: UW / m464415296X
• Lokale URL Inst.: Zum Volltext

Abstract

Statistical Challenges in the Analysis of Biomarker Data -- 2. Evaluating Predictive Accuracy of Prognostic Model for Censored Time-to-Event Data Analysis in Clinical Trials -- Statistical Methods for Accommodating Immortal Time: A Selective Review and Comparison -- Variable selection for partially functional additive Cox Model with interval-censored failure time data -- A Bayesian proportional hazards model to predict patient recruitment in multicenter clinical trials -- GET MORE INFORMATION FROM RECURRENT EVENTS DATA -- Introduction to Patient Preference Studies -- Machine Learning for Precision Medicine and Humanized AI for Future Healthcare -- The Statistical Evaluation of Surrogate Endpoints in Clinical Trials -- Treatment Effect Estimation Using Data from Observational and Non-Randomized Studies -- Methods for Comparing Two Treatments for a Dichotomous Outcome for a Two-Period Design with Treatment Switching of Control Group Period 1 Non-Responders -- Regression-based estimation of optimal adaptive treatment strategies: Key methods -- Vaccine Disease-Prevention Efficacy Studies: Traditional Approaches and New Frontiers -- Covariate Adjustment in Analyzing Randomized Clinical Trials: Approaches, Software, and Application -- Joint correlated responses and feedback effect with time-dependent covariates -- Distributions and Their Approximations for P-Values.

Abstract

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 2 covers Biomarkers in Drug Development, Time-To-Event Data Analysis and Methods, and emerging development in biopharmaceutical biostatistics. This book aims to booster research, education, and training in biostatistics and in biopharmaceutical research and development. .