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.
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.
Din Chen is a Fellow of the American Statistical Association and is currently the executive director and professor in biostatistics at the College of Health Solutions, Arizona State University. He is also an Extraordinary Professor and the SARChI in biostatistics at the University of Pretoria, and an honorary professor at the University of KwaZulu-Natal, South Africa. He is a senior biostatistics consultant for biopharmaceuticals and government agencies with extensive expertise in biostatistics, clinical trials, and public health statistics. Dr. Chen has more than 200 referred professional publications and co-authored 11 books and co-edited 24 books on clinical trial methodology, meta-analysis, data science, causal inference, and public health research. Professor Chen is the Deming publicity chair and he has been honored with the "Award of Recognition" from the Deming Conference Committee for highly successful advanced biostatistics workshop tutorials with his books.
