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 a
Adaptive Design Methods in Clinical Trials
โ Scribed by Shein-Chung Chow (Author); Mark Chang (Author)
- Publisher
- Chapman and Hall/CRC
- Year
- 2011
- Leaves
- 368
- Edition
- 2
- Category
- Library
No coin nor oath required. For personal study only.
โฆ Synopsis
With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA`s recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clini
โฆ Table of Contents
Introduction. Protocol Amendment. Adaptive Randomization. Adaptive Hypotheses. Adaptive Dose-Escalation Trials. Adaptive Group Sequential Design. Statistical Tests for Seamless Adaptive Designs. Adaptive Sample Size Adjustment. Two-Stage Adaptive Design. Adaptive Treatment Switching. Bayesian Approach. Biomarker Adaptive Trials. Target Clinical Trials. Sample Size and Power Estimation. Clinical Trial Simulation. Regulatory Perspectives- A Review of FDA Draft Guidance. Case Studies. Bibliography. Subject Index.
โฆ Subjects
Bioscience;Pharmaceutical Science;Clinical Trials - Pharmaceutical Science;Medicine, Dentistry, Nursing & Allied Health;Medicine;Medical Statistics & Computing
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