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Produktbild: The Agile Approach to Adaptive Research

The Agile Approach to Adaptive Research Optimizing Efficiency in Clinical Development

Aus der Reihe Wiley Series on Technologies for the Pharmaceutical Industry

122,99 €

inkl. gesetzl. MwSt., Versandkostenfrei

Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

08.02.2010

Herausgeber

Sean Ekins

Verlag

John Wiley & Sons

Seitenzahl

304

Maße (L/B/H)

23,6/15,5/2 cm

Gewicht

544 g

Auflage

1. Auflage

Sprache

Englisch

ISBN

978-0-470-24751-8

Beschreibung

Rezension

"This book certainly brings the relevant issues upfront." (Chemistry & Industry, June 2010)
"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." (Journal of Clinical Research Best Practices, April 2010)
 
"Rosenberg captures the current excitement surrounding adaptive clinical research, and provides a very readable introduction to the methodologies involved in implementing such research." (Journal for Clinical Studies, March 2010)

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

08.02.2010

Herausgeber

Sean Ekins

Verlag

John Wiley & Sons

Seitenzahl

304

Maße (L/B/H)

23,6/15,5/2 cm

Gewicht

544 g

Auflage

1. Auflage

Sprache

Englisch

ISBN

978-0-470-24751-8

Herstelleradresse

Libri GmbH
Europaallee 1
36244 Bad Hersfeld
DE

Email: GPSR Kontakt

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  • Produktbild: The Agile Approach to Adaptive Research
  • Acknowledgements.
     
    Forward.
     
    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.
     
    2 Defining and Extending the Adaptive Approach.
     
    The 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 Research.
     
    Conclusion.
     
    3 Design Adaptations Part One: Finding the Right Dose.
     
    Background.
     
    Types of Design Adaptations.
     
    Order of Discussion.
     
    Dosing Nomenclature.
     
    etermining 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 vs. Maximizing Information.
     
    Surrogate Endpoints.
     
    Conclusion.
     
    4 Design Adaptations Part Two: Additional Design Changes.
     
    Sample-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 Randomization.
     
    Other Types of Design Adaptations.
     
    Noninferiority-to-Superiority Design.
     
    Adaptive Hypotheses and Subpopulations.
     
    Treatment Switching.
     
    Conclusions.
     
    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.
     
    6 Agile Clinical Development.
     
    Benefits of Agile Development.
     
    A Development Example.
     
    Program Planning.
     
    Safety Testing (Phase I).
     
    Design.
     
    Planning.
     
    Op