The Agile Approach to Adaptive Research Optimizing Efficiency in Clinical Development

The Agile Approach to Adaptive Research Optimizing Efficiency in Clinical Development by Michael J. Rosenberg, published by Wiley on February 8, 2010, spans 304 pages and is presented in English. This book addresses the inefficiencies currently plaguing the pharmaceutical industry, particularly in drug development. It offers insights into how adaptive research can streamline clinical trials, enabling faster and more efficient decision-making through the application of existing tools and techniques.
Readers will find a practical overview of drug development challenges and the advantages of adopting adaptive research methodologies. The book covers essential concepts such as design adaptations, sample-size reestimation, and agile clinical development. It also delves into statistical approaches, including frequentist and Bayesian methods, and discusses the role of data management technologies in enhancing clinical research. By integrating traditional principles with modern advancements, this edition illustrates how adaptive research can significantly improve the efficiency and integrity of clinical trials.
Official synopsis Publisher
Apply 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:
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The adaptive concept
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Design and operational adaptations
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Sample-size reestimation
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Agile clinical development
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Safety and dose finding
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Statistics in adaptive research, including frequentist andBayesian approaches
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Data management technologies
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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.
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