Practical Considerations for Adaptive Trial Design and Implementation

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 arena, it will serve as a valuable reference for researchers working in industry, governmental bodies and academia. This includes anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, clinical operation specialists, drug supplies managers, infrastructure providers. In spite of the increased efficiency of adaptive trials, which get drugs to patients faster through cost and time savings, the adoption of adaptive designs in clinical development is still relatively low. One of the chief reasons is the complexity of adaptive design trials as compared to traditional trials. Little has been published to address the practical aspects of these trials and recommend best practices and solutions. This volume does just that by addressing study design and conduct integrity, regulatory acceptance, advanced infrastructure used for complex randomization and clinical supply scenarios, change management for process and behavior modifications, resource requirements and the inclusion of outside entities in decision-making. The book consists of 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 scenarios the authors faced in trial implementation.§Bringing together the expertise of 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.§