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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 ...
List of contents
Acknowledgements.
Forward.
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.
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.
3 Design Adaptations Part One: Finding the Right Dose.
Background.
Types of Design Adaptations.
Order of Discussion.
Dosing Nomenclature.
etermining Maximum Safe Dose.
Single Arm.
Continual Reassessment Method.
Other Bayesian Dose-Finding Methods.
Determining Optimal Dose (Pruning).
Multiple Arms.
Improvements over Conventional Approaches to Dose Finding.
Dose Selection in Practice.
Optimizing Dose Selection.
Minimizing Costs vs. Maximizing Information.
Surrogate Endpoints.
Conclusion.
4 Design Adaptations Part Two: Additional Design Changes.
Sample-Size Reestimation.
The Trouble with Planning Estimates.
The High Cost of "Underbuilt" Studies.
The Benefits of Reestimation and Rightsizing.
Reestimation and Trial Stages.
Rules to Restrict Reestimation.
Adjusting Sample Size for Nuisance Parameters.
Seamless Designs: Combining Multiple Phases.
When to Consider Seamless Studies.
Seamless Phase I/Phase II Trials.
Seamless Phase II/Phase III Trials.
Planning Issues in Seamless Trials.
Phase I-II-III Designs.
Adaptive Randomization.
Response-Adaptive Randomization.
Other Forms of Adaptive Randomization.
Other Types of Design Adaptations.
Noninferiority-to-Superiority Design.
Adaptive Hypotheses and Subpopulations.
Treatment Switching.
Conclusions.
5 Operational Adaptations.
Design and Operational Adaptations.
The Nature and Significance of Operational Adaptations.
Implementing Operational Adaptations.
Enrollment and Other Site Issues.
Data Quality.
Monitoring.
Site Closeout and Database Lock.
Supporting Functions for Efficient Operations.
The Bottom Line.
6 Agile Clinical Development.
Benefits of Agile Development.
A Development Example.
Program Planning.
Safety Testing (Phase I).
Design.
Planning.
Op
Report
"This book certainly brings the relevant issues upfront." (Chemistry & Industry, June 2010)
"It is ideal for senior executives who want a strategic view of adaptive methods, managers looking for practical opportunities to significantly improve the efficiency of their operations, and statisticians interested in learning the broader ramifications of their arcane expertise." (Journal of Clinical Research Best Practices, April 2010)
"Rosenberg captures the current excitement surrounding adaptive clinical research, and provides a very readable introduction to the methodologies involved in implementing such research." (Journal for Clinical Studies, March 2010)
