Statistical Approaches In Oncology Clinical Development
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Statistical Approaches In Oncology Clinical Development
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Author : Satrajit Roychoudhury
language : en
Publisher: CRC Press
Release Date : 2018-12-07
Statistical Approaches In Oncology Clinical Development written by Satrajit Roychoudhury and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-12-07 with Mathematics categories.
Statistical Approaches in Oncology Clinical Development : Current Paradigm and Methodological Advancement presents an overview of statistical considerations in oncology clinical trials, both early and late phase of development. It illustrates how novel statistical methods can enrich the design and analysis of modern oncology trials. The authors include many relevant real life examples from the pharmaceutical industry and academia based on their first-hand experience. Along with relevant references, the book highlights current regulatory views. The book covers all aspects of cancer clinical trial starting from early phase development. The early part of the book covers novel phase I dose escalation design, exposure response analysis, and innovative phase II design. This includes early development strategy for cancer immunotherapy trials. The contributors also emphasized the role of biomarker and modern era of precision medicine. The second part focuses on the late stage development. This includes the application of adaptive design, safety analysis, and quality of life (QoL) data analysis. The final part discusses current regulatory perspective and challenges. Features: Covers a wide spectrum 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. 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.
Statistical Approaches In Oncology Clinical Development
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Author : Satrajiit Roychoudhury
language : en
Publisher:
Release Date : 2017
Statistical Approaches In Oncology Clinical Development written by Satrajiit Roychoudhury and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017 with MEDICAL categories.
"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 challenges which are commonly observed during setting up, conducting and reporting of oncology studies. This book will cover a wide variety of topics related to common challenges in cancer clinical trials across different stages of drug development."--Provided by publisher.
Handbook Of Statistics In Clinical Oncology
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Author : John Crowley
language : en
Publisher: CRC Press
Release Date : 2012-03-26
Handbook Of Statistics In Clinical Oncology written by John Crowley and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-03-26 with Mathematics categories.
Addressing the many challenges that have arisen since the publication of its predecessor, this third edition covers the newest developments involved in the design and analysis of cancer clinical trials. Accessible to statisticians in clinical trials as well as oncologists interested in clinical trial methodology, the book presents up-to-date statistical approaches to the design and analysis of oncology clinical trials. New topics in this edition include trial designs for targeted agents, Bayesian trial design, and the inclusion of high-dimensional data and imaging techniques. This edition also contains numerous figures and examples to better explain concepts.
Innovative Strategies Statistical Solutions And Simulations For Modern Clinical Trials
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Author : Mark Chang
language : en
Publisher: CRC Press
Release Date : 2019-03-20
Innovative Strategies Statistical Solutions And Simulations For Modern Clinical Trials written by Mark Chang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-20 with Mathematics categories.
"This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R & D) approach to a more innovative approach in which strategies are employed to compress and optimize the clinical development plan and associated timelines. However, these strategies are generally being considered on an individual trial basis and not as part of a fully integrated overall development program. Such optimization at the trial level is somewhat near-sighted and does not ensure cost, time, or development efficiency of the overall program. This book seeks to address this imbalance by establishing a statistical framework for overall/global clinical development optimization and providing tactics and techniques to support such optimization, including clinical trial simulations. Provides a statistical framework for achieve global optimization in each phase of the drug development process. Describes specific techniques to support optimization including adaptive designs, precision medicine, survival-endpoints, dose finding and multiple testing. Gives practical approaches to handling missing data in clinical trials using SAS. Looks at key controversial issues from both a clinical and statistical perspective. Presents a generous number of case studies from multiple therapeutic areas that help motivate and illustrate the statistical methods introduced in the book. Puts great emphasis on software implementation of the statistical methods with multiple examples of software code (both SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and "clinical/medical" perspectives.
Statistical Methods In Biomarker And Early Clinical Development
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Author : Liang Fang
language : en
Publisher: Springer Nature
Release Date : 2019-12-26
Statistical Methods In Biomarker And Early Clinical Development written by Liang Fang and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-12-26 with Medical categories.
This contributed volume offers a much-needed overview of the statistical methods in early clinical drug and biomarker development. Chapters are written by expert statisticians with extensive experience in the pharmaceutical industry and regulatory agencies. Because of this, the data presented is often accompanied by real world case studies, which will help make examples more tangible for readers. The many applications of statistics in drug development are covered in detail, making this volume a must-have reference. Biomarker development and early clinical development are the two critical areas on which the book focuses. By having the two sections of the book dedicated to each of these topics, readers will have a more complete understanding of how applying statistical methods to early drug development can help identify the right drug for the right patient at the right dose. Also presented are exciting applications of machine learning and statistical modeling, along with innovative methods and state-of-the-art advances, making this a timely and practical resource. This volume is ideal for statisticians, researchers, and professionals interested in pharmaceutical research and development. Readers should be familiar with the fundamentals of statistics and clinical trials.
Textbook Of Clinical Trials In Oncology
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Author : Susan Halabi
language : en
Publisher: CRC Press
Release Date : 2019-04-24
Textbook Of Clinical Trials In Oncology written by Susan Halabi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-24 with Medical categories.
There is an increasing need for educational resources for statisticians and investigators. Reflecting this, the goal of this book is to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. Furthermore, it is intended as a guide for statisticians and investigators with minimal clinical trial experience who are interested in pursuing a career in this area. The advancement in genetic and molecular technologies have revolutionized drug development. In recent years, clinical trials have become increasingly sophisticated as they incorporate genomic studies, and efficient designs (such as basket and umbrella trials) have permeated the field. This book offers the requisite background and expert guidance for the innovative statistical design and analysis of clinical trials in oncology. Key Features: Cutting-edge topics with appropriate technical background Built around case studies which give the work a "hands-on" approach Real examples of flaws in previously reported clinical trials and how to avoid them Access to statistical code on the book’s website Chapters written by internationally recognized statisticians from academia and pharmaceutical companies Carefully edited to ensure consistency in style, level, and approach Topics covered include innovating phase I and II designs, trials in immune-oncology and rare diseases, among many others
Advanced Statistics In Regulatory Critical Clinical Initiatives
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Author : Wei Zhang
language : en
Publisher: CRC Press
Release Date : 2022-05-25
Advanced Statistics In Regulatory Critical Clinical Initiatives written by Wei Zhang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-05-25 with Mathematics categories.
Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields. Key Features: Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development. Makes recommendations to evaluate submissions accurately and reliably. Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development. Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.
Handbook Of Statistics In Clinical Oncology Second Edition
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Author : John Crowley
language : en
Publisher: Chapman and Hall/CRC
Release Date : 2005-12-01
Handbook Of Statistics In Clinical Oncology Second Edition written by John Crowley and has been published by Chapman and Hall/CRC this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-12-01 with Mathematics categories.
A compendium of cutting-edge statistical approaches to solving problems in clinical oncology, Handbook of Statistics in Clinical Oncology, Second Edition focuses on clinical trials in phases I, II, and III, proteomic and genomic studies, complementary outcomes and exploratory methods. Cancer Forum called the first edition a “1⁄4good reference book for statisticians who will be designing and analyzing cancer trials." The second edition includes over 1000 references, more than forty world-renowned contributors, and 300 equations, tables, and drawings. During the five years since publication of the first edition, there has been an explosion in the technological capabilities supporting genomic and proteomic research, which are is now firmly implanted in clinical oncology. Reflecting these developments, the second edition contains a new section devoted to analyses of high-throughput data and bioinformatics. Previous chapters of the first edition have been revised to reflect current state of the art in their respective domains. The intended audience is primarily statisticians working in cancer and more generally, in any discipline of medicine. But oncologists too will find the material accessible and will benefit from a rudimentary understanding of the fundamental concepts laid forth in each chapter. Completely revised while keeping the features that made the first edition a bestseller, this is the best single source for up-to-date statistical approaches to research in clinical medicine. More than just an update of the handbook that became the gold standard, this second edition brings you fully into the genomic era of medicine.
Handbook Of Statistics In Clinical Oncology
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Author : John Crowley
language : en
Publisher: CRC Press
Release Date : 2005-12-01
Handbook Of Statistics In Clinical Oncology written by John Crowley and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-12-01 with Mathematics categories.
A compendium of cutting-edge statistical approaches to solving problems in clinical oncology, Handbook of Statistics in Clinical Oncology, Second Edition focuses on clinical trials in phases I, II, and III, proteomic and genomic studies, complementary outcomes and exploratory methods. Cancer Forum called the first edition a
Introduction To Statistical Methods For Clinical Trials
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Author : Thomas D. Cook
language : en
Publisher: CRC Press
Release Date : 2007-11-19
Introduction To Statistical Methods For Clinical Trials written by Thomas D. Cook and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-11-19 with Mathematics categories.
Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors' collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various stati