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

Description

Statistical Approaches in Oncology Clinical Development: Current Paradigm and Methodological Advancement (PDF) provides a comprehensive examination of statistical methodologies pertinent to oncology clinical trials throughout various developmental phases, from early to late stages. This ebook highlights how innovative statistical techniques can significantly enhance the design and analytical processes of contemporary oncology studies. Drawing on their extensive firsthand experiences, the authors present a rich array of real-world examples from both the pharmaceutical sector and academic settings, making the content relevant and practical. Furthermore, it incorporates impactful references that underscore the latest regulatory viewpoints.

This ebook delves into all facets of cancer clinical trials, beginning with the intricacies of early-phase development. The initial sections focus on pioneering phase I dose-escalation strategies, exposure-response analyses, and cutting-edge phase II designs, including innovative methodologies aimed at cancer immunotherapy trials. The contributors place a strong emphasis on the critical role of biomarkers within the context of modern precision medicine, ensuring that readers grasp the significance of these elements in current research.

The latter sections of the ebook shift attention to late-stage development and its unique challenges and opportunities. Here, readers will find detailed discussions on adaptive design applications, comprehensive safety analyses, and the evaluation of quality of life (QoL) data in clinical studies. These insights are crucial for understanding the evolving landscape of oncology research and navigating regulatory hurdles effectively.

Key Features:

• In-depth case studies that illuminate real-world applications of statistical methods.
• A diverse array of topics addressing genuine statistical challenges faced in oncology clinical trials.
• A thorough overview of cutting-edge statistical approaches aimed at enhancing trial design and statistical evaluation.

Additional ISBNs: 978-1351650472, 978-0367828981, 978-1498772709, 978-1315154435, 978-1498772693, 0367828987, 1498772706, 9781498772709, 9781315154435, 978-1498772709.

Reviews

“This ebook meticulously covers all key elements of statistics relevant to clinical oncology, addressing statistical considerations in phase I oncology trials, response assessments, and interaction metrics vital for evaluating predictive biomarkers. It also explores intricate design elements for phase II oncology clinical trials, delving into the challenges posed by precision medicine, the utilization of adaptive designs in later-stage studies, and safety monitoring protocols.” — Luca Bertolaccini, ISCB

“What stands out about this ebook is its exceptional compilation of contributions from various authors, including academics, industry professionals, and even insights from the FDA. It offers an enlightening exploration of the current paradigm in oncology clinical trials. The chapters extend well beyond the conventional randomized, parallel-controlled trials typically associated with phase III, instead tracing the trajectory from phase I development through phases II and III while considering quality of life (QoL) factors and regulatory perspectives. Each chapter can be read independently for a focused understanding of specific stages of trial design or pertinent subject matter.” — Kelley M. Kidwell, Biometrics Journal

NOTE: The product exclusively comprises the ebook, Statistical Approaches in Oncology Clinical Development: Current Paradigm and Methodological Advancement in PDF format. Access codes are not included.