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

ISBN-13: 9781032338781 / Angielski / Miękka / 2022 / 236 str.

Satrajit Roychoudhury; Soumi Lahiri

Opis

Oncology is a rapidly developing area in medical science. A significant investment in terms of costs, resources and time is required for oncology drug development. Understanding of the challenges at all stages is vital for a successful drug launching. The purpose of this book is to provide an overview and practical solutions to some of these cha

Spis treści

1. Introduction 2. Statistical Considerations in Phase I Oncology Trials 3. Exposure–Response Analysis in Oncology Trials 4. Statistical Measures of Interaction for Evaluating a Predictive Biomarker 5. Design Considerations for Phase II Oncology Clinical Trials 6. Precision Medicine and Associated Challenges 7. Use of Adaptive Design in Late-Stage Oncology Trials 8. Safety Monitoring and Analysis in Oncology Trials 9. Quality of Life 10. Impact of Evolving Regulatory Pathways on Statistical Considerations in Oncology Clinical Trials

O autorze

Satrajit Roychoudhury is a Senior Director and a member of the Statistical Research and Innovation group in Pfizer Inc. Prior to joining; he was a member of Statistical Methodology and consulting group in Novartis. He has 11 years of extensive experience in working with different phases of clinical trial. His area of research includes early phase oncology trials, survival analysis, model informed drug development, and use of Bayesian methods in clinical trials. He is industry co-chair for the ASA Biopharmaceutical Section Regulatory-Industry Workshop and has provided statistical training in major conferences including the Joint Statistical Meetings, ASA Biopharmaceutical Section Regulatory-Industry Workshop, and ICSA Applied Statistics Symposium.

Soumi Lahiri has 12 years of extensive experience in working different therapeutic areas. She is the former Director of Biostatistics in Clinical Oncology, GlaxoSmithKline. She has also worked in the oncology division of Novartis Pharmaceutical Company for two years. She is an active member of the ASA Biopharmaceutical section and former chair of the membership committee.