| Description |
1 online resource (1 volume) : illustrations |
| Contents |
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 |
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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 |
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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 |
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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 |
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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 |
| Summary |
"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 trials that can be found in today's clinical setting including open-labeled trials, multicentered trials, and superiority trials. It also explores such ongoing, cutting-edge trials as early cancer & heart disease, mother to child human immunodeficiency virus transmission, women's health initiative dietary, and AIDS"--Provided by publisher |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record |
| Subject |
Clinical trials -- Statistical methods
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Mathematics.
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Physical sciences.
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Public health.
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Medical care.
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Statistics.
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Evaluation Studies as Topic
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Epidemiologic Methods
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Epidemiologic Study Characteristics as Topic
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Mathematics
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Health Care Evaluation Mechanisms
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Investigative Techniques
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Natural Science Disciplines
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Public Health
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Quality of Health Care
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Disciplines and Occupations
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Environment and Public Health
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Health Care Quality, Access, and Evaluation
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Analytical, Diagnostic and Therapeutic Techniques and Equipment
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Delivery of Health Care
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Statistics as Topic
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Clinical Trials as Topic
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Patient Care
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applied mathematics.
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mathematics.
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physical sciences.
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public health.
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statistics.
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Statistics
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Public health
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Physical sciences
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Medical care
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Mathematics
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Clinical trials -- Statistical methods
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| Form |
Electronic book
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| Author |
Balakrishnan, N., 1956- editor.
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| ISBN |
9781118595916 |
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1118595912 |
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9781118595923 |
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1118595920 |
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111830473X |
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9781118304730 |
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