Handbook of Adaptive Designs in Pharmaceutical and Clinical Development pdf

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Edition: 1
Publisher: CRC Press
Binding: Hardcover
ISBN: 1439810168

Handbook of Adaptive Designs in Pharmaceutical and Clinical Development

In response to the US FDA’s Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development. Medical books Handbook of Adaptive Designs in Pharmaceutical and Clinical Development. STRONG> Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a comprehensive and unified presentation of the principles and latest statistical methodologies used when modifying trial procedures based on accrued data of ongoing clinical trials. The book also gives a well-balanced summary of current regulatory perspectives.

The first several chapters focus on the fundamental theory behind adaptive trial design, the application of the Bayesian approach to adaptive designs, and the impact of potential population shift due to protocol amendments. The book then presents a variety of statistical methods for group sequential design, classical design, dose-finding trials, Phase I/II and Phase II/III seamless adaptive designs, multiple stage seamless adaptive trial design, adaptive randomization trials, hypotheses-adaptive design, and treatment-adaptive design Medical books Handbook Of Adaptive Designs In Pharmaceutical And Clinical Development Pong, An. format hardback language english publication year 27 10 2010 subject engineering technology subject 2 engineering technology textbooks study guides title handbook of adaptive designs in pharmaceutical and clinical development author pong annpey editor chow shein chung editor publisher crc pr i llc publication date nov 01 2010 pages 600 binding hardcover edition 1 st dimensions 7 24 wx 10 35 hx 1 14 d isbn 1439810168 subject mathematics probability statistics general description this comprehens

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format hardback language english publication year 27 10 2010 subject engineering technology subject 2 engineering technology textbooks study guides title handbook of adaptive designs in pharmaceutical and clinical development author pong annpey editor chow shein chung editor publisher crc pr i llc publication date nov 01 2010 pages 600 binding hardcover edition 1 st dimensions 7 24 wx 10 35 hx 1 14 d isbn 1439810168 subject mathematics probability statistics general description this comprehens

"This comprehensive guide offers a unified presentation of the principles and methodologies in adaptive design and analysis. It gives a well-balanced summary of current regulatory perspectives and recently developed statistical methods in this area. The handbook provides some insight regarding early phase and later phase adaptive designs. With a focus on the implementation of adaptive methods in clinical trials, it introduces the concepts of role, responsibility, function, and activity of a data safety monitoring board (DSMB) when applying these methods. Other important topics covered in detai

"In response to the US FDA's Critical Path Initiative , innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a comprehensive and unified presentation of the principles and latest statistical methodologies used when modifying trial procedures based on accrued data of ongoing clinical trials. The book also gives a well-balanced summary of current regulatory perspectives. The first several chapters focus on the

Medical Book Handbook of Adaptive Designs in Pharmaceutical and Clinical Development

STRONG> Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a comprehensive and unified presentation of the principles and latest statistical methodologies used when modifying trial procedures based on accrued data of ongoing clinical trials. The book also gives a well-balanced summary of current regulatory perspectives.

The first several chapters focus on the fundamental theory behind adaptive trial design, the application of the Bayesian approach to adaptive designs, and the impact of potential population shift due to protocol amendments. The book then presents a variety of statistical methods for group sequential design, classical design, dose-finding trials, Phase I/II and Phase II/III seamless adaptive designs, multiple stage seamless adaptive trial design, adaptive randomization trials, hypotheses-adaptive design, and treatment-adaptive design. It also covers predictive biomarker diagnostics for new drug development, clinical strategies for endpoint selection in translational research, the role of independent data monitoring committees in adaptive clinical trials, the enrichment process in targeted clinical trials for personalized medicine, applications of adaptive designs that use genomic or genetic information, adaptive trial simulation, and the efficiency of adaptive design. The final chapters discuss case studies as well as standard operating procedures for good adaptive practices.

With contributions from leading clinical researchers in the pharmaceutical industry, academia, and regulatory agencies, this handbook offers an up-to-date, complete treatment of the principles and methods of adaptive design and analysis. Along with reviewing recent developments, it examines issues commonly encountered when applying adaptive design methods in clinical trials.