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![]( "Buchcover ISBN 9780470599679")
„This book certainly brings the relevant issues upfront.“(Chemistry & Industry, June 2010)
„It is ideal for senior executives who want a strategic view ofadaptive methods, managers looking for practical opportunities tosignificantly improve the efficiency of their operations, andstatisticians interested in learning the broader ramifications oftheir arcane expertise.“ (Journal of Clinical Research BestPractices, April 2010)
„Rosenberg captures the current excitement surrounding adaptiveclinical research, and provides a very readable introduction to themethodologies involved in implementing such research.“ (Journalfor Clinical Studies, March 2010)
The Agile Approach to Adaptive Research
Optimizing Efficiency in Clinical Development
von Michael J. RosenbergApply adaptive research to improve results in drugdevelopment
The pharmaceutical industry today faces a deepening crisis: inefficiency in its core business, the development of new drugs. The Agile Approach to Adaptive Research offers a solution. It outlines how adaptive research, using already-available toolsand techniques, can enable the industry to streamline clinicaltrials and reach decision points faster and more efficiently.
With a wealth of real-world cases and examples, author MichaelRosenberg gives readers a practical overview of drug development, the problems inherent in current practices, and the advantages ofadaptive research technology and methods. He explains the concepts, principles, and specific techniques of adaptive research, anddemonstrates why it is an essential evolutionary step towardimproving drug research and development.
Chapters explore such subjects as:
* The adaptive concept
* Design and operational adaptations
* Sample-size reestimation
* Agile clinical development
* Safety and dose finding
* Statistics in adaptive research, including frequentist andBayesian approaches
* Data management technologies
* The future of clinical development
By combining centuries-old intellectual foundations, recenttechnological advances, and modern management techniques, adaptiveresearch preserves the integrity and validity of clinical researchbut dramatically improves efficiency.
The pharmaceutical industry today faces a deepening crisis: inefficiency in its core business, the development of new drugs. The Agile Approach to Adaptive Research offers a solution. It outlines how adaptive research, using already-available toolsand techniques, can enable the industry to streamline clinicaltrials and reach decision points faster and more efficiently.
With a wealth of real-world cases and examples, author MichaelRosenberg gives readers a practical overview of drug development, the problems inherent in current practices, and the advantages ofadaptive research technology and methods. He explains the concepts, principles, and specific techniques of adaptive research, anddemonstrates why it is an essential evolutionary step towardimproving drug research and development.
Chapters explore such subjects as:
* The adaptive concept
* Design and operational adaptations
* Sample-size reestimation
* Agile clinical development
* Safety and dose finding
* Statistics in adaptive research, including frequentist andBayesian approaches
* Data management technologies
* The future of clinical development
By combining centuries-old intellectual foundations, recenttechnological advances, and modern management techniques, adaptiveresearch preserves the integrity and validity of clinical researchbut dramatically improves efficiency.
