This volume set 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.

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.- Statistical Challenges in the Analysis of Biomarker Data.- 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.

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. This volume set 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.

Disseminates the development of biostatistical methodology in biopharmaceutical industries Advocates the biostatistics in FDA drug regulation and approvals Presents 80 years of contribution and dedication of the Deming Conference on Applied Statistics

GPSR Compliance The European Union's (EU) General Product Safety Regulation (GPSR) is a set of rules that requires consumer products to be safe and our obligations to ensure this. If you have any concerns about our products you can contact us on ProductSafety@springernature.com. In case Publisher is established outside the EU, the EU authorized representative is: Springer Nature Customer Service Center GmbH Europaplatz 3 69115 Heidelberg, Germany ProductSafety@springernature.com