LEADER 05603nam 2200745Ia 450 001 9910810182203321 005 20200520144314.0 010 $a9786612547645 010 $a9781282547643 010 $a128254764X 010 $a9780470599686 010 $a0470599685 010 $a9780470599679 010 $a0470599677 035 $a(CKB)2670000000009571 035 $a(EBL)487636 035 $a(SSID)ssj0000356422 035 $a(PQKBManifestationID)11925354 035 $a(PQKBTitleCode)TC0000356422 035 $a(PQKBWorkID)10349050 035 $a(PQKB)10203962 035 $a(Au-PeEL)EBL487636 035 $a(CaPaEBR)ebr10376664 035 $a(CaONFJC)MIL254764 035 $a(FINmELB)ELB178879 035 $a(MiAaPQ)EBC487636 035 $a(OCoLC)587390006 035 $a(Perlego)2777360 035 $a(EXLCZ)992670000000009571 100 $a20090929d2010 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 14$aThe agile approach to adaptive research $eoptimizing efficiency in clinical development /$fMichael J. Rosenberg 205 $a1st ed. 210 $aHoboken, N.J. $cWiley$dc2010 215 $a1 online resource (296 p.) 225 1 $aWiley series on technologies for the pharmaceutical industry 300 $aDescription based upon print version of record. 311 08$a9780470247518 311 08$a0470247517 320 $aIncludes bibliographical references and index. 327 $aThe 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 327 $a2 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 327 $aThe 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 327 $a4 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 327 $aOther 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 327 $aA Development Example 330 $aApply adaptive research to improve results in drug development The pharmaceutical industry today faces a deepening crisis: inefficiency in its core business, the development of new drugs. The Agile Approach to Adaptive Research offers a solution. It outlines how adaptive research, using already-available tools and techniques, can enable the industry to streamline clinical trials and reach decision points faster and more efficiently. With a wealth of real-world cases and examples, author Michael Rosenberg gives readers a practical overview of drug development, the problems inh 410 0$aWiley series on technologies for the pharmaceutical industry. 606 $aDrug development 606 $aPharmaceutical industry 615 0$aDrug development. 615 0$aPharmaceutical industry. 676 $a615/.19 700 $aRosenberg$b Michael J$01601635 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910810182203321 996 $aThe agile approach to adaptive research$93925289 997 $aUNINA