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Books > Science & Mathematics > Biology, life sciences > Life sciences: general issues
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Practical Considerations for Adaptive Trial Design and Implementation (Paperback, Softcover reprint of the original 1st ed. 2014)
Loot Price: R5,796
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Practical Considerations for Adaptive Trial Design and Implementation (Paperback, Softcover reprint of the original 1st ed. 2014)
Series: Statistics for Biology and Health
Expected to ship within 18 - 22 working days
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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.
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