Practical Considerations for Adaptive Trial Design and Implementation, Weili He; Jos? Pinheiro; Olga M. Kuznetsova
Автор: Weili He; Jos? Pinheiro; Olga M. Kuznetsova Название: Practical Considerations for Adaptive Trial Design and Implementation ISBN: 149391099X ISBN-13(EAN): 9781493910991 Издательство: Springer Рейтинг: Цена: 23757.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: 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.
Описание: This volume will cover what is known regarding the biology and treatment of CNS metastasis, including novel chapters such as the future of targeted therapies. It will begin with an overview of the natural history and risk factors for CNS metastases that will broadly cover all cancer histologies. This will be followed by 3 chapters that will cover the biology. These include: molecular biology, discussing what is known about specific genes/proteins involved in the process and model systems to study brain metastasis; the brain microenvironment, focusing on how it is different from the microenvironment of other organs of the body; and the blood-brain barrier, which includes a discussion of permeability with respect to brain metastases. A chapter on experimental imaging will cover both the biology of brain metastasis from an imaging perspective and use of imaging techniques to study brain metastases. The clinical chapters will discuss treatment options with separate chapters on surgery, chemotherapy and radiation. In addition, leptomeningeal metastasis will be given its own chapter. Finally, quality of life issues will be the concluding chapter.
Описание: Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics (PK) studies, and the design and analysis of efficacy studies.
