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Group Sequential And Confirmatory Adaptive Designs In Clinical Trials Springer

Jese Leos
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Published in Group Sequential And Confirmatory Adaptive Designs In Clinical Trials (Springer In Pharmaceutical Statistics)
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Group sequential and confirmatory adaptive designs are gaining significant attention in the field of clinical trials. These innovative approaches allow researchers to make early decision-making based on interim analyses while maintaining the validity and integrity of the study. One prominent resource for understanding and implementing these designs is the book "Group Sequential and Confirmatory Adaptive Designs in Clinical Trials" by Springer.

The Importance of Adaptive Designs

Clinical trials play a crucial role in testing the effectiveness and safety of new drugs, treatments, or interventions. Traditional fixed-sample designs require researchers to wait until the end of the study to analyze the data and draw s. However, with the advent of adaptive designs, researchers can now assess the results at interim stages, potentially saving time, reducing costs, and increasing efficiency.

Understanding Group Sequential Designs

Group sequential designs enable researchers to analyze data at interim stages while maintaining control over the type I error rate. This allows for early stopping of the trial if there is sufficient evidence of treatment efficacy or futility. The book by Springer provides a comprehensive overview of group sequential designs, including theoretical foundations, statistical methods, and practical examples.

Group Sequential and Confirmatory Adaptive Designs in Clinical Trials (Springer in Pharmaceutical Statistics)
Group Sequential and Confirmatory Adaptive Designs in Clinical Trials (Springer Series in Pharmaceutical Statistics)
by Nicola Zanetti(1st ed. 2016 Edition, Kindle Edition)

4.5 out of 5

Language : English
File size : 10028 KB
Screen Reader : Supported
Print length : 317 pages

Confirmatory Adaptive Designs

Confirmatory adaptive designs, also known as seamless designs, combine the benefits of both group sequential and adaptive designs. These designs allow for continuous adaptations based on accumulating data, maintaining the integrity of the study while providing flexibility to modify the trial parameters when necessary. The book by Springer provides in-depth coverage of confirmatory adaptive designs, including various strategies and considerations.

Key Features of the Book

The book "Group Sequential and Confirmatory Adaptive Designs in Clinical Trials" by Springer offers several key features that make it a valuable resource for researchers and statisticians:

  • Comprehensive coverage of group sequential and confirmatory adaptive designs
  • Detailed explanations of theoretical foundations and statistical methods
  • Practical examples and case studies to highlight real-world applications
  • Guidance on sample size determination and power calculations
  • Discussion of regulatory aspects and challenges of implementing adaptive designs
  • Insights from leading experts in the field

Group sequential and confirmatory adaptive designs offer the potential to improve the efficiency and effectiveness of clinical trials. The book "Group Sequential and Confirmatory Adaptive Designs in Clinical Trials" by Springer serves as an invaluable resource for researchers, statisticians, and other professionals in the field. By understanding and implementing these innovative designs, we can advance medical research and improve patient outcomes.

Group Sequential and Confirmatory Adaptive Designs in Clinical Trials (Springer in Pharmaceutical Statistics)
Group Sequential and Confirmatory Adaptive Designs in Clinical Trials (Springer Series in Pharmaceutical Statistics)
by Nicola Zanetti(1st ed. 2016 Edition, Kindle Edition)

4.5 out of 5

Language : English
File size : 10028 KB
Screen Reader : Supported
Print length : 317 pages

This book provides an up-to-date review of the general principles of and techniques for confirmatory adaptive designs. Confirmatory adaptive designs are a generalization of group sequential designs. With these designs, interim analyses聽are performed in order to stop the trial prematurely under control of the Type I error rate. In adaptive designs, it is also permissible to perform a data-driven change of relevant aspects of the study design at interim stages. This includes, for example, a sample-size reassessment, a treatment-arm selection or a selection of a pre-specified sub-population.

Essentially, this adaptive methodology was introduced in the 1990s. Since then, it has become popular and the object of intense discussion and still represents a rapidly growing field of statistical research. This book describes adaptive design methodology at an elementary level, while also considering designing and planning issues as well as methods for analyzing an adaptively planned trial. This includes estimation methods and methods for the determination of an overall p-value. Part I of the book provides the group sequential methods that are necessary for understanding and applying the adaptive design methodology supplied in Parts II and III of the book. The book contains many examples that illustrate use of the methods for practical application.

The book is primarily written for applied statisticians from academia and industry who are interested in confirmatory adaptive designs. It is assumed that readers are familiar with the basic principles of descriptive statistics, parameter estimation and statistical testing. This book will also be suitable for an advanced statistical course for applied statisticians or clinicians with a sound statistical background.

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