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.
