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Methods and applications of statistics in clinical trials. Volume 1, Concepts, principles, trials, and design /
"This comprehensive book features both new and established material on the key statistical principles and concepts for designing modern-day clinical trials, such as hazard ratio, flexible designs, confounding, covariates, missing data, and longitudinal data. It discusses the various kinds of tr...
| Clasificación: | Libro Electrónico |
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| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken, New Jersey :
John Wiley & Sons Inc.,
[2014]
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| Temas: | |
| Acceso en línea: | Texto completo (Requiere registro previo con correo institucional) |
Tabla de Contenidos:
- Cover; Title Page; Copyright Page; Contents; Contributors; Preface; 1 Absolute Risk Reduction; 1.1 Introduction; 1.2 Preliminary Issues; 1.3 Point and Interval Estimates for a Single Proportion; 1.4 An Unpaired Difference of Proportions; 1.5 Number Needed to Treat; 1.6 A Paired Difference of Proportions; References; Further Reading; 2 Accelerated Approval; 2.1 Introduction; 2.2 Accelerated Development Versus Expanded Access in the U.S.A.; 2.3 Sorting the Terminology-Which FDA Initiatives Do What?; 2.4 Accelerated Approval Regulations: 21 C.F.R. 314.500, 314.520, 601.40
- 2.5 Stages of Drug Development and FDA Initiatives2.6 Accelerated Approval Regulations: 21 CFR 314.500, 314.520, 601.40; 2.7 Accelerated Approval with Surrogate Endpoints; 2.7.1 What is a Surrogate Endpoint?; 2.7.2 What is a Biomarker?; 2.8 Accelerated Approval with Restricted Distribution; 2.9 Phase IV Studies/Post Marketing Surveillance; 2.10 Benefit Analysis for Accelerated Approvals Versus Other Illnesses; 2.11 Problems, Solutions, and Economic Incentives; 2.12 Future Directions; References; Further Reading; 3 AIDS Clinical Trials Group (ACTG); 3.1 Introduction
- 3.2 A Brief Primer on HIV/AIDS3.3 ACTG Overview; 3.3.1 History; 3.3.2 ACTG Structure; 3.4 ACTG Scientific Activities; 3.5 Development of Potent Antiretroviral Therapy (ART); 3.5.2 Drug Development, Pharmacology (PK), and Pharmacogenomics; 3.5.3 Immunology, Pathogenesis, and Translational Research; 3.5.4 OIs and other AIDS-Related Complications; 3.6 Expert Systems and Infrastructure; References; 4 Algorithm-Based Designs; 4.1 Phase I Dose-Finding Studies; 4.1.1 Algorithm-Based A + B Designs; 4.1.2 Modification of A + B Designs and Derivation of Key Statistical Properties
- 4.1.3 Advantages and Drawbacks of Algorithm-based Designs4.2 Accelerated Designs; 4.2.1 A Modification of the Accelerated Designs; 4.3 Model-Based Approach in the Estimation of MTD; 4.3.1 Evaluation of the Traditional Algorithm-based 3 + 3 Design; 4.3.2 Model-based Approach in the Estimation of MTD; 4.4 Exploring Algorithm- Based Designs with Prespecified Targeted Toxicity Levels; 4.4.1 Rationale for Exploring the Properties of Algorithm-Based Designs; 4.4.2 Simulation Study Design and Results; References; 5 Alpha-Spending Function; 5.1 Introduction; 5.2 Alpha Spending Function Motivation
- 5.3 The Alpha Spending Function5.4 Application of the Alpha Spending Function; 5.5 Confidence Intervals and Estimation; 5.6 Trial Design; 5.7 Conclusions; References; Further Reading; 6 Application of New Designs in Phase I Trials; 6.1 Introduction; 6.2 Objectives of a Phase I Trial; 6.3 Standard Designs and Their Shortcomings; 6.3.1 The Standard 3 + 3 Design; 6.3.2 The Accelerated Titration Design; 6.4 Some Novel Designs; 6.4.1 The Continual Reassessment Method; 6.4.2 Extensions of the CRM for Efficacy Outcomes; 6.4.3 Bayesian Adaptive Designs; 6.4.4 Efficacy and Toxicity for Dose Finding