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1. |
Record Nr. |
UNINA9910140620203321 |
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Autore |
Rosenberg Michael J |
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Titolo |
The agile approach to adaptive research [[electronic resource] ] : optimizing efficiency in clinical development / / Michael J. Rosenberg |
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Pubbl/distr/stampa |
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Hoboken, N.J., : Wiley, c2010 |
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ISBN |
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1-282-54764-X |
9786612547645 |
0-470-59968-5 |
0-470-59967-7 |
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Descrizione fisica |
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1 online resource (296 p.) |
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Collana |
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Wiley series on technologies for the pharmaceutical industry |
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Disciplina |
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Soggetti |
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Drug development |
Pharmaceutical industry |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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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 |
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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 |
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Sommario/riassunto |
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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 |
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2. |
Record Nr. |
UNINA9910974032603321 |
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Autore |
Townsend Robert |
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Titolo |
Barriers to Household Risk Management : : Evidence from India / / Robert Townsend, Shawn Cole, Jeremy Tobacman, Xavier Gine, James Vickery, Petia Topalova |
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Pubbl/distr/stampa |
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Washington, D.C. : , : International Monetary Fund, , 2012 |
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ISBN |
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9781475565478 |
147556547X |
9781475512342 |
1475512341 |
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Edizione |
[1st ed.] |
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Descrizione fisica |
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1 online resource (44 p.) |
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Collana |
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IMF Working Papers |
IMF working paper ; ; WP/12/195 |
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Altri autori (Persone) |
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ColeShawn |
GineXavier |
TobacmanJeremy |
TopalovaPetia |
VickeryJames |
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Disciplina |
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Soggetti |
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Financial risk - India |
Risk management - India |
Actuarial Studies |
Asset and liability management |
Consumption |
Corporate Finance and Governance |
Economic Development: Financial Markets |
Economics |
Education |
Education: General |
Field Experiments |
Finance |
Finance: General |
Financial Institutions and Services: General |
Financial institutions |
Financial Instruments |
Industries: Financial Services |
Institutional Investors |
Insurance & actuarial studies |
Insurance Companies |
Insurance companies |
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Insurance |
Investment Decisions |
Liquidity |
Macroeconomics |
Macroeconomics: Consumption |
National accounts |
Non-bank Financial Institutions |
Pension Funds |
Personal Finance |
Portfolio Choice |
Saving and Capital Investment |
Saving |
Wealth |
United States |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references. |
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Nota di contenuto |
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Cover; Abstract; Contents; I. Introduction; II. Insurance Contract Design and Summary Statistics; A. Product Description; B. Summary Statistics; III. Experimental Design; IV. Experimental Results; A. Andhra Pradesh; B. Gujarat: Video Experiments; C. Gujarat: Flyer Experiments; V. Discussion of Experimental Results; A. Price Relative to Actuarial Value; B. Trust; C. Liquidity Constraints; D. Financial Literacy and Education; E. Framing, Salience and Other Behavioral Factors; VI. Non-Experimental Evidence; A. Correlates of Insurance Purchase; B. Self-Reported Explanations for Non-Purchase |
VII. Improving Household Risk Management: Tentative Lessons and ConclusionsReferences; VIII. Appendix |
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Sommario/riassunto |
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Why do many households remain exposed to large exogenous sources of non-systematic income risk? We use a series of randomized field experiments in rural India to test the importance of price and non-price factors in the adoption of an innovative rainfall insurance product. Demand is significantly price sensitive, but widespread take-up would not be achieved even if the product offered a payout ratio comparable to U.S. insurance contracts. We present evidence suggesting that lack of trust, liquidity constraints and limited salience are significant non-price frictions that constrain demand. We suggest contract design improvements to mitigate these frictions. |
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