{"product_id":"the-agile-approach-to-adaptive-research-optimizing-efficiency-in-clinical-development-hardback-9780470247518","title":"The Agile Approach to Adaptive Research; Optimizing Efficiency in Clinical Development (Hardback) 9780470247518","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eThe Agile Approach to Adaptive Research\u003c\/font\u003e\u003cbr\u003e\r\n\u003cfont size=\"5\"\u003eOptimizing Efficiency in Clinical Development\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eMichael J. Rosenberg (Author), Sean Ekins (Series edited by)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780470247518, Wiley\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 5 March 2010\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e304 pages\u003cbr\u003e23.6 x 15.2 x 2.3 cm, 0.567 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cem\u003e\u003cfont size=\"3\"\u003e\"This book certainly brings the relevant issues upfront.\" (\u003ci\u003eChemistry \u0026amp; Industry\u003c\/i\u003e, June 2010)\u003cbr\u003e \u003cbr\u003e  \"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.\" (\u003ci\u003eJournal of Clinical Research Best Practices\u003c\/i\u003e, April 2010)  \u003cp\u003e\"Rosenberg captures the current excitement surrounding adaptive clinical research, and provides a very readable introduction to the methodologies involved in implementing such research.\" (\u003ci\u003eJournal for Clinical Studies\u003c\/i\u003e, March 2010)\u003c\/p\u003e\u003c\/font\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003cb\u003eApply adaptive research to improve results in drug development\u003c\/b\u003e  \u003cp\u003eThe pharmaceutical industry today faces a deepening crisis: inefficiency in its core business, the development of new drugs. \u003ci\u003eThe Agile Approach to Adaptive Research\u003c\/i\u003e 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.\u003c\/p\u003e \u003cp\u003eWith 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.\u003c\/p\u003e \u003cp\u003eChapters explore such subjects as:\u003c\/p\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eThe adaptive concept\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eDesign and operational adaptations\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eSample-size reestimation\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eAgile clinical development\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eSafety and dose finding\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eStatistics in adaptive research, including frequentist and Bayesian approaches\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eData management technologies\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eThe future of clinical development\u003c\/p\u003e \u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eBy 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.\u003c\/p\u003e\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003ePreface.  \u003cp\u003eAcknowledgments.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Opportunity for Efficiency.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThe Adaptive Solution.\u003c\/p\u003e \u003cp\u003eAn Industrial Success Story.\u003c\/p\u003e \u003cp\u003eSigns of Trouble Ahead.\u003c\/p\u003e \u003cp\u003eConverging Challenges.\u003c\/p\u003e \u003cp\u003eThe Struggle to Replace Lost Revenues.\u003c\/p\u003e \u003cp\u003eClinical Research is the Key.\u003c\/p\u003e \u003cp\u003eBehind the High Costs of Clinical Development.\u003c\/p\u003e \u003cp\u003eHigh Costs and Increasing Prices.\u003c\/p\u003e \u003cp\u003eGrowing Pressures Mandate Greater Efficiency.\u003c\/p\u003e \u003cp\u003eThe High Risk of Current Development Practices.\u003c\/p\u003e \u003cp\u003eEconomic Consequences of Faster Clinical Development.\u003c\/p\u003e \u003cp\u003eThriving in a New Era.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Defining and Extending the Adaptive Approach.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThe Adaptive Concept.\u003c\/p\u003e \u003cp\u003eKnowledge, Time and Decision-Making.\u003c\/p\u003e \u003cp\u003eThe Value of Early Knowledge.\u003c\/p\u003e \u003cp\u003eThe Spectrum of Design and Operational Adaptations.\u003c\/p\u003e \u003cp\u003eMaximizing the Adaptive Approach: Agile Clinical Development.\u003c\/p\u003e \u003cp\u003eMeasure Performance in Real-time.\u003c\/p\u003e \u003cp\u003eMetrics in Action.\u003c\/p\u003e \u003cp\u003eRight Information to the Right Eyes at the Right Time.\u003c\/p\u003e \u003cp\u003eMake Timely Decisions.\u003c\/p\u003e \u003cp\u003eOrganize Work in Lean Processes.\u003c\/p\u003e \u003cp\u003eRework in Clinical Studies.\u003c\/p\u003e \u003cp\u003eBackflow of Patient Data.\u003c\/p\u003e \u003cp\u003eMatch Technology with Tasks.\u003c\/p\u003e \u003cp\u003eObjections to Adaptive Methods.\u003c\/p\u003e \u003cp\u003eIntegrity and Validity.\u003c\/p\u003e \u003cp\u003eThe Regulatory Environment.\u003c\/p\u003e \u003cp\u003eThe Complexity of Clinical Research.\u003c\/p\u003e \u003cp\u003eConclusion.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Design Adaptations Part One: Finding the Right Dose.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eBackground.\u003c\/p\u003e \u003cp\u003eTypes of Design Adaptations.\u003c\/p\u003e \u003cp\u003eOrder of Discussion.\u003c\/p\u003e \u003cp\u003eDosing Nomenclature.\u003c\/p\u003e \u003cp\u003eDetermining Maximum Safe Dose.\u003c\/p\u003e \u003cp\u003eSingle Arm.\u003c\/p\u003e \u003cp\u003eContinual Reassessment Method.\u003c\/p\u003e \u003cp\u003eOther Bayesian Dose-Finding Methods.\u003c\/p\u003e \u003cp\u003eDetermining Optimal Dose (Pruning).\u003c\/p\u003e \u003cp\u003eMultiple Arms.\u003c\/p\u003e \u003cp\u003eImprovements over Conventional Approaches to Dose Finding.\u003c\/p\u003e \u003cp\u003eDose Selection in Practice.\u003c\/p\u003e \u003cp\u003eOptimizing Dose Selection.\u003c\/p\u003e \u003cp\u003eMinimizing Costs versus Maximizing Information.\u003c\/p\u003e \u003cp\u003eSurrogate Endpoints.\u003c\/p\u003e \u003cp\u003eConclusion.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Design Adaptations Part Two: Additional Design Changes.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eSample-Size Reestimation.\u003c\/p\u003e \u003cp\u003eThe Trouble with Planning Estimates.\u003c\/p\u003e \u003cp\u003eThe High Cost of \"Underbuilt\" Studies.\u003c\/p\u003e \u003cp\u003eThe Benefits of Reestimation and Rightsizing.\u003c\/p\u003e \u003cp\u003eReestimation and Trial Stages.\u003c\/p\u003e \u003cp\u003eRules to Restrict Reestimation.\u003c\/p\u003e \u003cp\u003eAdjusting Sample Size for Nuisance Parameters.\u003c\/p\u003e \u003cp\u003eSeamless Designs: Combining Multiple Phases.\u003c\/p\u003e \u003cp\u003eWhen to Consider Seamless Studies.\u003c\/p\u003e \u003cp\u003eSeamless Phase I\/Phase II Trials.\u003c\/p\u003e \u003cp\u003eSeamless Phase II\/Phase III Trials.\u003c\/p\u003e \u003cp\u003ePlanning Issues in Seamless Trials.\u003c\/p\u003e \u003cp\u003ePhase I-II-III Designs.\u003c\/p\u003e \u003cp\u003eAdaptive Randomization.\u003c\/p\u003e \u003cp\u003eResponse-Adaptive Randomization.\u003c\/p\u003e \u003cp\u003eOther Forms of Adaptive Randomization.\u003c\/p\u003e \u003cp\u003eOther Types of Design Adaptations.\u003c\/p\u003e \u003cp\u003eNoninferiority-to-Superiority Design.\u003c\/p\u003e \u003cp\u003eAdaptive Hypotheses and Subpopulations.\u003c\/p\u003e \u003cp\u003eTreatment Switching.\u003c\/p\u003e \u003cp\u003eConclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Operational Adaptations.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eDesign and Operational Adaptations.\u003c\/p\u003e \u003cp\u003eThe Nature and Significance of Operational Adaptations.\u003c\/p\u003e \u003cp\u003eImplementing Operational Adaptations.\u003c\/p\u003e \u003cp\u003eEnrollment and Other Site Issues.\u003c\/p\u003e \u003cp\u003eData Quality.\u003c\/p\u003e \u003cp\u003eMonitoring.\u003c\/p\u003e \u003cp\u003eSite Closeout and Database Lock.\u003c\/p\u003e \u003cp\u003eSupporting Functions for Efficient Operations.\u003c\/p\u003e \u003cp\u003eThe Bottom Line.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Agile Clinical Development.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eBenefits of Agile Development.\u003c\/p\u003e \u003cp\u003eA Development Example.\u003c\/p\u003e \u003cp\u003eProgram Planning.\u003c\/p\u003e \u003cp\u003eSafety Testing (Phase I).\u003c\/p\u003e \u003cp\u003eDesign.\u003c\/p\u003e \u003cp\u003ePlanning.\u003c\/p\u003e \u003cp\u003eOperational Considerations.\u003c\/p\u003e \u003cp\u003ePutting the Plan into Action.\u003c\/p\u003e \u003cp\u003eBenefits Realized.\u003c\/p\u003e \u003cp\u003eTransition to Dose-Finding Study.\u003c\/p\u003e \u003cp\u003eDose Finding (Phase II).\u003c\/p\u003e \u003cp\u003eDesign.\u003c\/p\u003e \u003cp\u003ePlanning.\u003c\/p\u003e \u003cp\u003eOperational Considerations.\u003c\/p\u003e \u003cp\u003ePutting the Plan into Action.\u003c\/p\u003e \u003cp\u003eBenefits Realized.\u003c\/p\u003e \u003cp\u003eTransition to Confirmatory Studies.\u003c\/p\u003e \u003cp\u003eConfirmatory Testing (Phase III).\u003c\/p\u003e \u003cp\u003eDesign.\u003c\/p\u003e \u003cp\u003ePlanning.\u003c\/p\u003e \u003cp\u003eOperational.\u003c\/p\u003e \u003cp\u003ePutting the Plan into Action.\u003c\/p\u003e \u003cp\u003eBenefits Realized.\u003c\/p\u003e \u003cp\u003eTransition to Regulatory Filings.\u003c\/p\u003e \u003cp\u003eSumming Up: The Power of Agile Development.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Planning Adaptive Programs.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eDetermining Design Adaptations and their Requirements.\u003c\/p\u003e \u003cp\u003eDetermining Operational Requirements to Support Design Adaptations.\u003c\/p\u003e \u003cp\u003eEnsuring the Ability to Meet Operational Requirements.\u003c\/p\u003e \u003cp\u003eThe Importance of Programmatic Thinking.\u003c\/p\u003e \u003cp\u003eLooking Ahead.\u003c\/p\u003e \u003cp\u003eAdvisory and Oversight Groups.\u003c\/p\u003e \u003cp\u003eOptimizing the Planning Process.\u003c\/p\u003e \u003cp\u003eRegulatory Discussions.\u003c\/p\u003e \u003cp\u003eContingency Planning.\u003c\/p\u003e \u003cp\u003ePlanning Tools and Techniques.\u003c\/p\u003e \u003cp\u003eDecision Trees.\u003c\/p\u003e \u003cp\u003eSimulation.\u003c\/p\u003e \u003cp\u003eUncertainties in Clinical Research.\u003c\/p\u003e \u003cp\u003eSimulation Tools.\u003c\/p\u003e \u003cp\u003eSimulation Step by Step.\u003c\/p\u003e \u003cp\u003eThe Limitations of Simulation.\u003c\/p\u003e \u003cp\u003eConclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003eSources of Simulation Software.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Statistics and Decision Making in Adaptive Research.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThe Frequentist Approach.\u003c\/p\u003e \u003cp\u003eWhat Frequentist Results Say about the Results of a Clinical Study.\u003c\/p\u003e \u003cp\u003eUsing Frequentist Results to Make Decisions Based on Individual Trials.\u003c\/p\u003e \u003cp\u003eOther Issues with Frequentist Methods.\u003c\/p\u003e \u003cp\u003eThe Bayesian Approach.\u003c\/p\u003e \u003cp\u003ePrior Distributions.\u003c\/p\u003e \u003cp\u003eHow Bayesian Statistics Works.\u003c\/p\u003e \u003cp\u003eBayesian Statistics in the Real World.\u003c\/p\u003e \u003cp\u003eBayesian Methods in Clinical Research.\u003c\/p\u003e \u003cp\u003eComparing Bayesian and Frequentist Methods.\u003c\/p\u003e \u003cp\u003ePrior Distributions.\u003c\/p\u003e \u003cp\u003eThe Pharma Context.\u003c\/p\u003e \u003cp\u003eLearning and Confirming.\u003c\/p\u003e \u003cp\u003eEthical and Operational Issues.\u003c\/p\u003e \u003cp\u003eRegulatory Considerations.\u003c\/p\u003e \u003cp\u003eConclusions.\u003c\/p\u003e \u003cp\u003eFrequentists, Bayesians, and Pragmatists.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 The Agile Platform.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eEssential Types of Data.\u003c\/p\u003e \u003cp\u003eManagement Cycles in Clinical Studies.\u003c\/p\u003e \u003cp\u003eThe Common Platform for Design and Operational Adaptations.\u003c\/p\u003e \u003cp\u003eData Capture.\u003c\/p\u003e \u003cp\u003eData-Capture Technologies.\u003c\/p\u003e \u003cp\u003eThe First Generation.\u003c\/p\u003e \u003cp\u003eThe Second Generation.\u003c\/p\u003e \u003cp\u003eThe Third Generation.\u003c\/p\u003e \u003cp\u003eData Cleaning and Validation Technology.\u003c\/p\u003e \u003cp\u003eData Analysis Tools.\u003c\/p\u003e \u003cp\u003eRandomization.\u003c\/p\u003e \u003cp\u003eSite Management.\u003c\/p\u003e \u003cp\u003eSupply-Chain Management.\u003c\/p\u003e \u003cp\u003eCommunications.\u003c\/p\u003e \u003cp\u003eConclusions.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 The Future of Clinical Development.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eIs Restructuring an Alternative to Improving Clinical Development?\u003c\/p\u003e \u003cp\u003eGreater Efficiency: Changes that Everyone Can Applaud.\u003c\/p\u003e \u003cp\u003eBiotechs and Emerging Low-Cost Competitors.\u003c\/p\u003e \u003cp\u003eGlobalization, Offshoring, and Outsourcing.\u003c\/p\u003e \u003cp\u003eManaging More Complex Trials.\u003c\/p\u003e \u003cp\u003eIndividualized Medicine Demands Greater Efficiency.\u003c\/p\u003e \u003cp\u003eA More Important Role for Postmarketing Studies.\u003c\/p\u003e \u003cp\u003eThe Reward for Greater Efficiency.\u003c\/p\u003e \u003cp\u003eFinancial Implications of the Agile Approach.\u003c\/p\u003e \u003cp\u003eFinancial Implications of the Agile Approach for the Drug Industry.\u003c\/p\u003e \u003cp\u003eA Brighter Future for Clinical Development.\u003c\/p\u003e \u003cp\u003eFirst Steps toward Agile Development.\u003c\/p\u003e \u003cp\u003eAn Eight-Point Program for Embracing the Adaptive Approach.\u003c\/p\u003e \u003cp\u003eReferences.\u003c\/p\u003e \u003cp\u003eIndex.\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Chemistry [\u003ca title=\"See our other books on Chemistry\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Chemistry%20%5BPN%5D%22\"\u003ePN\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Wiley","offers":[{"title":"Brand New","offer_id":52257220362520,"sku":"9780470247518","price":61.99,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/files\/9780470247518.jpg?v=1781278036","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/the-agile-approach-to-adaptive-research-optimizing-efficiency-in-clinical-development-hardback-9780470247518","provider":"Freshly Printed Books","version":"1.0","type":"link"}