Practical Considerations for Adaptive Trial Design and Implementation

Nonfiction, Health & Well Being, Medical, Reference, Biostatistics, Science & Nature, Mathematics, Science, Biological Sciences
Cover of the book Practical Considerations for Adaptive Trial Design and Implementation by , Springer New York
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
Author: ISBN: 9781493911004
Publisher: Springer New York Publication: October 15, 2014
Imprint: Springer Language: English
Author:
ISBN: 9781493911004
Publisher: Springer New York
Publication: October 15, 2014
Imprint: Springer
Language: English

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.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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.

More books from Springer New York

Cover of the book Health Services and Health Hazards: The Employee’s Need to Know by
Cover of the book High Performance Multi-Channel High-Speed I/O Circuits by
Cover of the book Introduction to Clinical Informatics by
Cover of the book Rapid and Practical Interpretation of Urodynamics by
Cover of the book The Gifted Child in Peer Group Perspective by
Cover of the book Words as Social Tools: An Embodied View on Abstract Concepts by
Cover of the book Real Analysis by
Cover of the book The New Paradigm of Immunity to Tuberculosis by
Cover of the book The Beagle Brain in Stereotaxic Coordinates by
Cover of the book Pediatric Cranial MRI by
Cover of the book Teaching Creatively and Teaching Creativity by
Cover of the book Pharmaceutical Suspensions by
Cover of the book Photoemission from Optoelectronic Materials and their Nanostructures by
Cover of the book Sleep Loss and Obesity by
Cover of the book Handbook of Operations Research for Homeland Security by
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy