The agile approach to adaptive research [[electronic resource] ] : optimizing efficiency in clinical development / / Michael J. Rosenberg

• Record Nr.: UNINA9910140620203321
• Autore: Rosenberg Michael J
• Pubbl/distr/stampa: Hoboken, N.J., : Wiley, c2010
• ISBN: 1-282-54764-X; 9786612547645; 0-470-59968-5; 0-470-59967-7
• Descrizione fisica: 1 online resource (296 p.)
• Collana: Wiley series on technologies for the pharmaceutical industry
• Disciplina: 615/.19
• Soggetti: Drug development; Pharmaceutical industry
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references and index.
• Nota di contenuto: The Agile Approach to Adaptive Research: Optimizing Efficiency in Clinical Development; Contents; 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 ApproachThe 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 ResearchConclusion; References; 3 Design ; Adaptations Part One: Finding the Right Dose; Background; Types of Design Adaptations; Order of Discussion; Dosing Nomenclature; Determining 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 Versus Maximizing Information; Surrogate Endpoints; Conclusion; References; 4 Design Adaptations Part Two: Additional Design ChangesSample-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 RandomizationOther Types of Design Adaptations; Noninferiority-to-Superiority Design; Adaptive Hypotheses and Subpopulations; Treatment Switching; Conclusions; References; 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; References; 6 Agile Clinical Development; Benefits of Agile Development; A Development Example
• Sommario/riassunto: Apply adaptive research to improve results in drug development 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 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 inh