It unifies the vast and continuously growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology.
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New to the Second Edition Along with revisions throughout the text, this edition significantly updates the chapters on protocol amendment and clinical trial simulation to incorporate the latest changes. It also includes five entirely new chapters on two-stage adaptive design, biomarker adaptive trials, target clinical trials, sample size and power estimation, and regulatory perspectives.
Following in the tradition of its acclaimed predecessor, this second edition continues to offer an up-to-date resource for clinical scientists and researchers in academia, regulatory agencies, and the pharmaceutical industry.
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We did a search for other books with a similar title, however there were no matches. You can try selecting from a similar category, click on the author's name, or use the search box above to find your book. Click on the cover image above to read some pages of this book! With new statistical and scientific issues arising in adaptive clinical trial design, including the U. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed.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
Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and continuously growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology.
New to the Second Edition Along with revisions throughout the text, this edition significantly updates the chapters on protocol amendment and clinical trial simulation to incorporate the latest changes. Convert currency. Add to Basket.
Adaptive Design Methods in Clinical Trials (Biostatistics) - PDF Free Download
Condition: New. Language: English. Brand new Book. Get Up to Speed on Many Types of Adaptive DesignsSince the publication of the first edition, there have been remarkable advances in the methodology and application of adaptive trials.
Adaptative Design Methods in Clinical Trials, 2nd Edition
New to the Second EditionTwelve new chapters covering blinded and semi-blinded sample size reestimation design, pick-the-winners design, biomarker-informed adaptive design, Bayesian designs, adaptive multiregional trial design, SAS and R for group sequential design, and much moreMore analytical methods for K-stage adaptive designs, multiple-endpoint adaptive design, survival modeling, and adaptive treatment switchingNew material on sequential parallel designs with rerandomization and the skeleton approach in adaptive dose-escalation trialsTwenty new SAS macros and R functionsEnhanced end-of-chapter problems that give readers hands-on practice addressing issues encountered in designing real-life adaptive trialsCovering even more adaptive designs, this book provides biostatisticians, clinical scientists, and regulatory reviewers with up-to-date details on this innovative area in pharmaceutical research and development.
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