05603nam 2200745Ia 450 991081018220332120200520144314.097866125476459781282547643128254764X9780470599686047059968597804705996790470599677(CKB)2670000000009571(EBL)487636(SSID)ssj0000356422(PQKBManifestationID)11925354(PQKBTitleCode)TC0000356422(PQKBWorkID)10349050(PQKB)10203962(Au-PeEL)EBL487636(CaPaEBR)ebr10376664(CaONFJC)MIL254764(FINmELB)ELB178879(MiAaPQ)EBC487636(OCoLC)587390006(Perlego)2777360(EXLCZ)99267000000000957120090929d2010 uy 0engur|n|---|||||txtccrThe agile approach to adaptive research optimizing efficiency in clinical development /Michael J. Rosenberg1st ed.Hoboken, N.J. Wileyc20101 online resource (296 p.)Wiley series on technologies for the pharmaceutical industryDescription based upon print version of record.9780470247518 0470247517 Includes bibliographical references and index.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; References2 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 EnvironmentThe 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; References4 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 RandomizationOther 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 DevelopmentA Development ExampleApply 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 inhWiley series on technologies for the pharmaceutical industry.Drug developmentPharmaceutical industryDrug development.Pharmaceutical industry.615/.19Rosenberg Michael J1601635MiAaPQMiAaPQMiAaPQBOOK9910810182203321The agile approach to adaptive research3925289UNINA