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Informationen zum Autor MICHAEL J. ROSENBERG, MD, MPH , is President and Chief Executive Officer of Health Decisions, Inc. Involved in the design and execution of pharmaceutical development programs for more than twenty-five years, Dr. Rosenberg was selected as Entrepreneur of the Year by Ernst & Young (Health Sector, SE). His company's innovative applications of technology have been recognized by the CIO Enterprise Value Award and the Cisco Growing with Technology Award. Health Decisions has also been named three times to the Deloitte & Touche Technology Fast 500 and the Inc. 500. Dr. Rosenberg is the author of more than 150 scientific articles and serves on advisory groups in business, technology, and medicine. Klappentext Apply adaptive research to improve results in drug developmentThe 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 tools and techniques, can enable the industry to streamline clinical trials and reach decision points faster and more efficiently.With a wealth of real-world cases and examples, author Michael Rosenberg gives readers a practical overview of drug development, the problems inherent in current practices, and the advantages of adaptive research technology and methods. He explains the concepts, principles, and specific techniques of adaptive research, and demonstrates why it is an essential evolutionary step toward improving 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 and Bayesian approaches* Data management technologies* The future of clinical developmentBy combining centuries-old intellectual foundations, recent technological advances, and modern management techniques, adaptive research preserves the integrity and validity of clinical research but dramatically improves efficiency. Zusammenfassung This book helps pharmaceutical and medical researchers better understand, design, and manage clinical trials through its industry-specific viewpoint that shows how adaptive research technology and methods benefit the drug industry. Inhaltsverzeichnis Preface. Acknowledgments. 1 Opportunity for Efficiency. The Adaptive Solution. An Industrial Success Story. Signs of Trouble Ahead. Converging Challenges. The Struggle to Replace Lost Revenues. Clinical Research is the Key. Behind the High Costs of Clinical Development. High Costs and Increasing Prices. Growing Pressures Mandate Greater Efficiency. The High Risk of Current Development Practices. Economic Consequences of Faster Clinical Development. Thriving in a New Era. References. 2 Defining and Extending the Adaptive Approach. The Adaptive Concept. Knowledge, Time and Decision-Making. The Value of Early Knowledge. The Spectrum of Design and Operational Adaptations. Maximizing the Adaptive Approach: Agile Clinical Development. Measure Performance in Real-time. Metrics in Action. Right Information to the Right Eyes at the Right Time. Make Timely Decisions. Organize Work in Lean Processes. Rework in Clinical Studies. Backflow of Patient Data. Match Technology with Tasks. Objections to Adaptive Methods. Integrity and Validity. The Regulatory Environment. The Complexity of Clinical Research. Conclusion. References. 3 Design Adaptations Part One: Finding the Right Dose. Background. Types of Design Adaptations. Order of ...
