Adaptive Design Methods in Clinical Trials

Adaptive Design Methods in Clinical Trials

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Although adaptive design methods are flexible and useful in clinical research, little or no regulatory guidelines are available. One of the first books on the topic, Adaptive Design Methods in Clinical Trials presents the principles and methodologies in adaptive design and analysis that pertain to adaptations made to trial or statistical procedures that are based on accrued data of ongoing clinical trials. The book also offers a well-balanced summary of current regulatory perspectives and recently developed statistical methods in this area. After an introduction to basic concepts and statistical considerations of adaptive design methods, the book questions the impact on target patient populations as the result of protocol amendments and discusses the generalization of statistical inference. The authors also present various adaptive design methods, including where hypotheses are modified during the conduct of clinical trials, for dose selection, and commonly used adaptive group sequential design methods in clinical trials. Following a discussion of blind procedures for sample size re-estimation, the book describes statistical tests for seamless phase II/III adaptive designs and statistical inference for switching adaptively from one treatment to another. The book concludes with computer simulations and various case studies of clinical trials.By providing theoretical and computer simulation results, method comparisons, and practical guidelines for choosing an optimal design, Adaptive Design Methods in Clinical Trials fills the need for a unified, comprehensive, and updated resource in the clinical research and development of adaptive design and more

Product details

  • Electronic book text | 296 pages
  • Taylor & Francis Ltd
  • Chapman & Hall/CRC
  • London, United Kingdom
  • 1000 equations; 56 Tables, black and white; 21 Illustrations, black and white
  • 158488777X
  • 9781584887775

Table of contents

INTRODUCTION What Is Adaptive Design Regulatory Perspectives Target Patient Population Statistical Inference Practical IssuesAims and Scope of the BookPROTOCOL AMENDMENTActual Patient Population Estimation of Shift and Scale ParametersStatistical InferenceSample Size AdjustmentStatistical Inference with Covariate AdjustmentConcluding RemarksADAPTIVE RANDOMIZATION Conventional Randomization Treatment-Adaptive Randomization Covariate-Adaptive Randomization Response-Adaptive Randomization Issues with Adaptive Randomization Summary ADAPTIVE HYPOTHESESModifications of Hypotheses Switch from Superiority to Noninferiority Concluding RemarksADAPTIVE DOSE-ESCALATION TRIALSIntroduction CRM in Phase I Oncology StudyHybrid Frequentist-Bayesian Adaptive DesignSimulationsConcluding RemarksADAPTIVE GROUP SEQUENTIAL DESIGN Sequential Methods General Approach for Group Sequential DesignEarly Stopping Boundaries Alpha Spending FunctionGroup Sequential Design Based on Independent P-Values Calculation of Stopping Boundaries Group Sequential Trial Monitoring Conditional Power Practical IssuesADAPTIVE SAMPLE SIZE ADJUSTMENT Sample Size Re-Estimation without Unblinding DataCui-Hung-Wang's MethodProschan-Hunsberger's Method Muller-Schafer Method Bauer-Kohne MethodGeneralization of Independent P-Value ApproachesInverse-Normal Method Concluding RemarksADAPTIVE SEAMLESS PHASE II/III DESIGNWhy a Seamless Design Is EfficientStep-wise Test and Adaptive Procedures Contrast Test and Naive P-Value Comparisons of Seamless Design Drop-the-Loser Adaptive Design SummaryADAPTIVE TREATMENT SWITCHINGLatent Event Times Proportional Hazard Model with Latent Hazard RateMixed Exponential ModelConcluding RemarksBAYESIAN APPROACH Basic Concepts of Bayesian ApproachMultiple-Stage Design for Single-Arm TrialBayesian Optimal Adaptive Designs Concluding Remarks CLINICAL TRIAL SIMULATIONSimulation FrameworkEarly Phases DevelopmentLate Phases DevelopmentSoftware ApplicationExamplesConcluding RemarksCASE STUDIESBasic ConsiderationsAdaptive Group Sequential Design Adaptive Dose-Escalation DesignAdaptive Seamless Phase II/III DesignSUBJECT INDEX BIBLIOGRAPHYshow more