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Practical Considerations for Adaptive Trial Design and Implementation

  • Weili He
  • José Pinheiro
  • Olga M. Kuznetsova

Part of the Statistics for Biology and Health book series (SBH)

Table of contents

  1. Front Matter
    Pages i-xx
  2. Design Considerations

  3. Trial Implementation Considerations

    1. Front Matter
      Pages 201-201
    2. Linda Danielson, Jerome Carlier, Tomasz Burzykowski, Marc Buyse
      Pages 225-240
    3. Nitin R. Patel, Suresh Ankolekar, Pralay Senchaudhuri
      Pages 273-297
  4. Case Studies

  5. Back Matter
    Pages 413-416

About this book

Introduction

This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers.  In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low.  One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, the need for an advanced infrastructure for complex randomization and clinical supply scenarios, change management for process and behavior modifications, extensive resource requirements for the planning and design of adaptive trials and the potential to relegate key decision makings to outside entities.  There have been limited publications that address these practical considerations and recommend best practices and solutions.  This book fills this publication gap, providing guidance on practical considerations for adaptive trial design and implementation.  The book comprises three parts:  Part I focuses on practical considerations from a design perspective, whereas Part II delineates practical considerations related to the implementation of adaptive trials. Putting it all together, Part III presents four illustrative case studies ranging from description and discussion of specific adaptive trial design considerations to the logistic and regulatory issues faced in trial implementation. 

Bringing together the expertise of leading key opinion leaders from pharmaceutical industry, academia, and regulatory agencies, this book provides a balanced and comprehensive coverage of practical considerations for adaptive trial design and implementation.

Keywords

adaptive clinical trials adaptive designs adaptive simulation clinical supply modeling optimal dose selection pharmaceutical clinical trials pharmaceutical trial design probability of success randomized clinical trials regulatory agency and clinical trials

Editors and affiliations

  • Weili He
    • 1
  • José Pinheiro
    • 2
  • Olga M. Kuznetsova
    • 3
  1. 1.Department of Clinical BiostatisticsMerck & Co., Inc.RahwayUSA
  2. 2.Johnson & JohnsonRaritanUSA
  3. 3.Department of Clinical BiostatisticsMerck & Co., Inc.RahwayUSA

Bibliographic information

  • DOI https://doi.org/10.1007/978-1-4939-1100-4
  • Copyright Information Springer Science+Business Media New York 2014
  • Publisher Name Springer, New York, NY
  • eBook Packages Mathematics and Statistics
  • Print ISBN 978-1-4939-1099-1
  • Online ISBN 978-1-4939-1100-4
  • Series Print ISSN 1431-8776
  • Series Online ISSN 2197-5671
  • Buy this book on publisher's site