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Statistical Approaches in Oncology Clinical Development: Current Paradigm and Methodological Advancement

Statistical Approaches in Oncology Clinical Development: Current Paradigm and Methodological Advancement

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  • More about Statistical Approaches in Oncology Clinical Development: Current Paradigm and Methodological Advancement


Statistical Approaches in Oncology Clinical Development provides an overview of statistical considerations in oncology clinical trials, including early and late phase development, with a focus on novel methods and real-life examples.

Format: Paperback / softback
Length: 236 pages
Publication date: 14 June 2022
Publisher: Taylor & Francis Ltd


Statistical Approaches in Oncology Clinical Development: Current Paradigm and Methodological Advancement delves into the realm of statistical considerations in oncology clinical trials, encompassing both early and late phases of development. It serves as a comprehensive guide, illustrating how novel statistical methods can enhance the design and analysis of modern oncology trials. The authors, drawn from both the pharmaceutical industry and academia, offer valuable insights based on their firsthand experiences. Alongside relevant references, the book highlights current regulatory perspectives, providing a valuable resource for professionals involved in cancer clinical research.

The book encompasses a comprehensive coverage of cancer clinical trial aspects, commencing with early phase development. The early chapters delve into innovative phase I dose escalation designs, exposure response analysis, and novel phase II designs, including early development strategies for cancer immunotherapy trials. The contributors also emphasize the role of biomarkers and the emerging era of precision medicine.

The second part of the book focuses on late-stage development, encompassing the application of adaptive design, safety analysis, and quality of life (QoL) data analysis. The final chapter discusses current regulatory perspectives and challenges, offering valuable insights into the evolving landscape of oncology clinical trials.

Key Features:
• Comprehensive coverage of a wide range of topics related to real-life statistical challenges in oncology clinical trials.
• Provides a comprehensive overview of novel statistical methods to improve trial design and statistical analysis.
• Detailed case studies illustrate the real-life applications of statistical methodologies.

Satrajit Roychoudhury, a Senior Director and member of the Statistical Research and Innovation group in Pfizer Inc., brings a wealth of experience to the book. With 11 years of extensive experience in working with different phases of clinical trials, he has contributed significantly to the field of statistical methodologies in oncology. His expertise and insights make this book a valuable resource for professionals, researchers, and students alike.

In conclusion, Statistical Approaches in Oncology Clinical Development: Current Paradigm and Methodological Advancement is a comprehensive and insightful guide that provides valuable insights into statistical considerations in oncology clinical trials. By leveraging novel statistical methods and real-life examples, the book empowers professionals to design and analyze more effective and efficient cancer clinical trials, ultimately advancing the field of cancer research and treatment.

Weight: 440g
Dimension: 234 x 156 (mm)
ISBN-13: 9781032338781

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