Biostatistics in Biopharmaceutical Research and Development

Biostatistics in Biopharmaceutical Research and Development

Clinical Trial Analysis

Chen, Ding-Geng

Springer International Publishing AG

01/2025

790

Dura

9783031773259

Pré-lançamento - envio 15 a 20 dias após a sua edição

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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.
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Biopharmaceuticals;clinical trials;biostatistics;statistics;public health