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Adaptive Design Methods in Clinical Trials
Af: Shein-Chung Chow, Mark Chang Engelsk Paperback
SPAR
kr 58
Adaptive Design Methods in Clinical Trials
Af: Shein-Chung Chow, Mark Chang Engelsk Paperback

With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA’s recent draft guidance, a new edition of one of the first books on the topic is needed.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 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. 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. Written in an intuitive style at a basic mathematical and statistical level, the book maintains its practical approach with an emphasis on concepts via numerous examples and illustrations.

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With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA’s recent draft guidance, a new edition of one of the first books on the topic is needed.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 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. 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. Written in an intuitive style at a basic mathematical and statistical level, the book maintains its practical approach with an emphasis on concepts via numerous examples and illustrations.

Produktdetaljer
Sprog: Engelsk
Sider: 374
ISBN-13: 9781032477602
Indbinding: Paperback
Udgave:
ISBN-10: 1032477601
Kategori: Kliniske forsøg
Udg. Dato: 21 jan 2023
Længde: 0mm
Bredde: 234mm
Højde: 156mm
Oplagsdato: 21 jan 2023
Forfatter(e): Shein-Chung Chow, Mark Chang
Forfatter(e) Shein-Chung Chow, Mark Chang


Kategori Kliniske forsøg


Sprog Engelsk


Indbinding Paperback


Sider 374


Udgave


Længde 0mm


Bredde 234mm


Højde 156mm


Udg. Dato 21 jan 2023


Oplagsdato 21 jan 2023

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