Statistical Approaches in Oncology Clinical Development: Current Paradigm and Methodological Advancement – eBook PDF
Statistical Approaches in Oncology Clinical Development: Current Paradigm and Methodological Advancement (PDF) offers an overview of statistical considerations in oncology clinical trials, both early and late phases of development. It shows how novel statistical methods can improve the design and analysis of modern oncology trials. The authors include many related real-life examples from the pharmaceutical industry and academia based on their first-hand experience. Together with relevant references, the ebook highlights current regulatory views.
The ebook covers all aspects of cancer clinical trials starting from early-phase development. The early part of the ebook includes novel phase I dose-escalation design, exposure-response analysis, and innovative phase II design. This includes an early development strategy for cancer immunotherapy trials. The contributors also stressed the role of biomarkers and the modern era of precision medicine. The second part emphasizes late-stage development. This includes the application of adaptive design, safety analysis, and quality of life (QoL) data analysis. The final part discusses the current regulatory perspective and challenges.
- Detailed case studies show real-life applications.
- Contains a wide spectrum of topics related to real-life statistical challenges in oncology clinical trials.
- Offers a comprehensive overview of novel statistical methods to improve trial design and statistical analysis.
Additional ISBNs: 978-1498772693, 0367828987, 1498772706, 1315154439, 9781498772709, 9781315154435, 978-1351650472, 978-0367828981, 978-1498772709, 978-1315154435, 9780367828981
“The ebook covers all features of statistics for clinical oncology, including statistical considerations in phase I oncology trials, response analysis in oncology trials, and statistical measures of interaction for evaluating a predictive biomarker. The ebook also studies design considerations for phase II oncology clinical trials, precision medicine and its related challenges, use of adaptive designs in late-stage oncology trials, and safety monitoring.” — Luca Bertolaccini, ISCB
“This ebook is an excellent compilation of chapters from various authors coming from academia, pharmaceutical companies, and even one from the food and drug administration (FDA) to inform readers about the present paradigm in oncology clinical trials. The chapters delve much deeper than the standard, randomized, parallel, controlled trials that we may expect in phase III and instead begin with phase I development, move into phases II and III, and consider the quality of life (QOL) and regulatory concerns. Thus, reading chronologically, the ebook offers a liberal overview spanning oncology drug development; each chapter, though, could be read separately to understand that particular phase of trial design or subject matter.” — Kelley M. Kidwell, Biometrics Journal
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