Biopharmaceutical applied statistics symposium. Design of clinical trials / Volume 1, ([2018])

• Record Type: Book
• Other Titles: Design of clinical trials
• Further Information: Note: Karl E. Peace, Ding-Geng Chen, Sandeep Menon, editors.
• Editors: Peace, Karl E, 1941-; Chen, Ding-Geng; Menon, Sandeep M
• Contents: Intro; Preface; Contents; Editors and Contributors; 1 A Statistical Approach to Clinical Trial Simulations; 1.1 Introduction; 1.2 Protocol Deviations; 1.2.1 Noncompliance; 1.2.2 Dropouts and Missing Data; 1.3 Methods; 1.4 The Clinical Trial Simulation System; 1.5 Some Published Clinical Trial Simulations; 1.6 Commercially Available Trial Design Software Packages; 1.7 Discussion; References; 2 Choosing the Function of Baseline Run-in Data for Use as a Covariate in the Analysis of Treatment Data from Phase III Clinical Trials in Hypertension; 2.1 Introduction; 2.2 Literature Review; 2.3 Theory 2.4 Patterns of Data2.4.1 Baseline Run-in, Pre-randomization Period; 2.4.2 Post Randomization Treatment Period; 2.5 Simulation; 2.5.1 Ranges and Size of the Cohort Over Baseline Run-in; 2.5.2 Baseline Run-in, Pre-randomization Period; 2.5.3 Post Randomization Treatment Period; 2.5.4 Data Simulation Process; 2.6 Statistical Assessment of Covariates; 2.6.1 Models Considered; 2.6.2 Analysis Strategy; 2.6.3 Analysis Results; 2.7 Conclusions; Appendix; References; 3 Adaptive Trial Design in Clinical Research; 3.1 Introduction; 3.2 What Is Adaptive Design?; 3.2.1 Adaptations 3.2.2 Type of Adaptive Designs3.2.3 Regulatory/Statistical Perspectives; 3.3 Impact of Protocol Amendments; 3.3.1 Moving Target Patient Population; 3.3.2 Statistical Inference with Covariate Adjustment; 3.3.3 Inference Based on Mixture Distribution; 3.4 Challenges in by Design Adaptations; 3.4.1 Adaptive Group Sequential Design; 3.4.2 Adaptive Dose Finding Design; 3.4.3 Adaptive Seamless Designs; 3.5 Obstacles of Retrospective Adaptations; 3.6 Concluding Remarks; References; 4 Best Practices in Clinical Trial Simulations for Adaptive Study Designs; 4.1 Introduction; 4.2 Motivation 4.3 Simulation Process4.3.1 Simulation Terminology; 4.3.2 Analysis Models and Assumptions; 4.3.3 Simulation Model; 4.3.4 Performance Metrics; 4.4 Scenario Planning; 4.5 Testing; 4.6 Benefits and Challenges; 4.7 Conclusions; References; 5 Designing and Analyzing Recurrent Event Data Trials; 5.1 Introduction; 5.2 Methods; 5.2.1 Time to First Event; 5.2.2 Multiple Events Per Subject; 5.2.3 Poisson Regression; 5.2.4 Negative Binomial Regression; 5.2.5 Extended Cox Models for Recurrent Events; 5.3 Illustrations; 5.3.1 Poisson Regression Data (N = 1000); 5.3.2 Poisson Regression Data (N = 25, 000) 5.3.3 Negative Binomial Regression (N = 25, 000)5.3.4 Comparing Estimates and Standard Errors; 5.3.5 Goodness of Fit; 5.3.6 Simulations; 5.4 Discussion; References; 6 Response-Adaptive Allocation for Binary Outcomes: Bayesian Methods from the BASS Conference; 6.1 Introduction; 6.2 Response-Adaptive Allocation; 6.2.1 Optimal Allocation; 6.2.2 Natural Lead-In; 6.3 General Bayesian Approach; 6.3.1 Posterior Estimates and Probabilities; 6.4 Example 1: The Decreasingly Informative Prior Approach; 6.4.1 Decreasingly-Informative Prior Model; 6.4.2 Simulation Study for DIP Model
• Publisher Details: Singapore : Springer
• Publication Date: 2018
• Extent: 1 online resource
• Subjects: 617.040287; Statistics; Drugs -- Testing -- Statistical methods -- Congresses; Biopharmaceutics -- Congresses; MEDICAL / Surgery / General; Statistics; Statistics for Life Sciences, Medicine, Health Sciences; Biostatistics; Biopharmaceutics; Drugs -- Testing -- Statistical methods; Science -- Life Sciences -- General; Life sciences: general issues; Statistical methods; Medical -- Biostatistics; Probability & statistics; Electronic books; Conference papers and proceedings
• Languages: English
• ISBNs: 9789811078293; 9811078297
• Related ISBNs: 9789811078286; 9811078289
• Notes: Note: Online resource; title from PDF title page (SpringerLink, viewed August 27, 2018).
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.