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Author: Shigeyuki Matsui Publisher: Springer ISBN: 981100126X Category : Medical Languages : en Pages : 439
Book Description
This book presents the state of the art of biostatistical methods and their applications in clinical oncology. Many methodologies established today in biostatistics have been brought about through its applications to the design and analysis of oncology clinical studies. This field of oncology, now in the midst of evolution owing to rapid advances in biotechnologies and cancer genomics, is becoming one of the most promising disease fields in the shift toward personalized medicine. Modern developments of diagnosis and therapeutics of cancer have also been continuously fueled by recent progress in establishing the infrastructure for conducting more complex, large-scale clinical trials and observational studies. The field of cancer clinical studies therefore will continue to provide many new statistical challenges that warrant further progress in the methodology and practice of biostatistics. This book provides a systematic coverage of various stages of cancer clinical studies. Topics from modern cancer clinical trials include phase I clinical trials for combination therapies, exploratory phase II trials with multiple endpoints/treatments, and confirmative biomarker-based phase III trials with interim monitoring and adaptation. It also covers important areas of cancer screening, prognostic analysis, and the analysis of large-scale molecular data in the era of big data.
Author: Shigeyuki Matsui Publisher: Springer ISBN: 981100126X Category : Medical Languages : en Pages : 439
Book Description
This book presents the state of the art of biostatistical methods and their applications in clinical oncology. Many methodologies established today in biostatistics have been brought about through its applications to the design and analysis of oncology clinical studies. This field of oncology, now in the midst of evolution owing to rapid advances in biotechnologies and cancer genomics, is becoming one of the most promising disease fields in the shift toward personalized medicine. Modern developments of diagnosis and therapeutics of cancer have also been continuously fueled by recent progress in establishing the infrastructure for conducting more complex, large-scale clinical trials and observational studies. The field of cancer clinical studies therefore will continue to provide many new statistical challenges that warrant further progress in the methodology and practice of biostatistics. This book provides a systematic coverage of various stages of cancer clinical studies. Topics from modern cancer clinical trials include phase I clinical trials for combination therapies, exploratory phase II trials with multiple endpoints/treatments, and confirmative biomarker-based phase III trials with interim monitoring and adaptation. It also covers important areas of cancer screening, prognostic analysis, and the analysis of large-scale molecular data in the era of big data.
Author: Raphael. L.C Araújo Publisher: Springer ISBN: 3319713248 Category : Medical Languages : en Pages : 354
Book Description
This book introduces and discusses the most important aspects of clinical research methods and biostatistics for oncologists, pursuing a tailor-made and practical approach. Evidence-based medicine (EBM) has been in vogue in the last few decades, particularly in rapidly advancing fields such as oncology. This approach has been used to support decision-making processes worldwide, sparking new clinical research and guidelines on clinical and surgical oncology. Clinical oncology research has many peculiarities, including specific study endpoints, a special focus on survival analyses, and a unique perspective on EBM. However, during medical studies and in general practice, these topics are barely taught. Moreover, even when EBM and clinical cancer research are discussed, they are presented in a theoretical fashion, mostly focused on formulas and numbers, rather than on clinical application for a proper literature appraisal. Addressing that gap, this book discusses more practical aspects of clinical research and biostatistics in oncology, instead of relying only on mathematical formulas and theoretical considerations. Methods and Biostatistics in Oncology will help readers develop the skills they need to understand the use of research on everyday oncology clinical practice for study design and interpretation, as well to demystify the use of EBM in oncology.
Author: Craig Beam Publisher: Springer Science & Business Media ISBN: 1475735715 Category : Medical Languages : en Pages : 242
Book Description
Biostatistics is defined as much by its application as it is by theory. This book provides an introduction to biostatistical applications in modern cancer research that is both accessible and valuable to the cancer biostatistician or to the cancer researcher, learning biostatistics. The topical areas include active areas of the application of biostatistics to modern cancer research: survival analysis, screening, diagnostics, spatial analysis and the analysis of microarray data. Biostatistics is an essential component of basic and clinical cancer research. The text, authored by distinguished figures in the field, addresses clinical issues in statistical analysis. The spectrum of topics discussed ranges from fundamental methodology to clinical and translational applications.
Author: John Crowley Publisher: CRC Press ISBN: 1439862001 Category : Mathematics Languages : en Pages : 661
Book Description
Many new challenges have arisen in the area of oncology clinical trials. New cancer therapies are often based on cytostatic or targeted agents, which pose new challenges in the design and analysis of all phases of trials. The literature on adaptive trial designs and early stopping has been exploding. Inclusion of high-dimensional data and imaging techniques have become common practice, and statistical methods on how to analyse such data have been refined in this area. A compilation of statistical topics relevant to these new advances in cancer research, this third edition of Handbook of Statistics in Clinical Oncology focuses on the design and analysis of oncology clinical trials and translational research. 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, incorporating updates to all four parts: Phase I trials: Updated recommendations regarding the standard 3 + 3 and continual reassessment approaches, along with new chapters on phase 0 trials and phase I trial design for targeted agents. Phase II trials: Updates to current experience in single-arm and randomized phase II trial designs. New chapters include phase II designs with multiple strata and phase II/III designs. Phase III trials: Many new chapters include interim analyses and early stopping considerations, phase III trial designs for targeted agents and for testing the ability of markers, adaptive trial designs, cure rate survival models, statistical methods of imaging, as well as a thorough review of software for the design and analysis of clinical trials. Exploratory and high-dimensional data analyses: All chapters in this part have been thoroughly updated since the last edition. New chapters address methods for analyzing SNP data and for developing a score based on gene expression data. In addition, chapters on risk calculators and forensic bioinformatics have been added. Accessible to statisticians and oncologists interested in clinical trial methodology, the book is a single-source collection of up-to-date statistical approaches to research in clinical oncology.
Author: Kara-Lynne Leonard, MD, MS Publisher: Springer Publishing Company ISBN: 0826168590 Category : Medical Languages : en Pages : 202
Book Description
Biostatistics for Oncologists is the first practical guide providing the essential biostatistical concepts, oncology-specific examples, and applicable problem sets for medical oncologists, radiation oncologists, and surgical oncologists. The book also serves as a review for medical oncology and radiation oncology residents or fellows preparing for in-service and board exams. All examples are relevant to oncology and demonstrate how to apply core conceptual knowledge and applicable methods related to hypothesis testing, correlation and regression, categorical data analysis and survival analysis to the field of oncology. The book also provides guidance on the fundamentals of study design and analysis. Written for oncologists by oncologists, this practical text demystifies challenging statistical concepts and provides concise direction on how to interpret, analyze, and critique data in oncology publications, as well as how to apply statistical knowledge to understanding, designing, and analyzing clinical trials. With practical problem sets and twenty-five multiple choice practice questions with answers, the book is an indispensable review for anyone preparing for in-service exams, boards, MOC, or looking to hone a lifelong skill. Key Features: Practically explains biostatistics concepts important for passing the hematology, medical oncology, and radiation oncology boards and MOC exams. Provides guidance on how to read, understand, and critique data in oncology publications. Gives relevant examples that are important for analyzing data in oncology, including the design and analysis of clinical trials. Tests your comprehension of key biostatistical concepts with problem sets at the end of each section and a final section devoted to board-style multiple choice questions and answers Includes digital access to the eBook
Author: Satrajit Roychoudhury Publisher: CRC Press ISBN: 1498772706 Category : Mathematics Languages : en Pages : 237
Book Description
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.
Author: Yichuan Zhao Publisher: Springer ISBN: 3319993895 Category : Mathematics Languages : en Pages : 463
Book Description
This book is comprised of presentations delivered at the 5th Workshop on Biostatistics and Bioinformatics held in Atlanta on May 5-7, 2017. Featuring twenty-two selected papers from the workshop, this book showcases the most current advances in the field, presenting new methods, theories, and case applications at the frontiers of biostatistics, bioinformatics, and interdisciplinary areas. Biostatistics and bioinformatics have been playing a key role in statistics and other scientific research fields in recent years. The goal of the 5th Workshop on Biostatistics and Bioinformatics was to stimulate research, foster interaction among researchers in field, and offer opportunities for learning and facilitating research collaborations in the era of big data. The resulting volume offers timely insights for researchers, students, and industry practitioners.
Author: John Crowley Publisher: CRC Press ISBN: 9780824790257 Category : Mathematics Languages : en Pages : 566
Book Description
This book compiles state-of-the-art statistical approaches to solving problems in clinical oncology, focusing on clinical trials in phases I, II, and III, as well as quality of life and economic analyses, and exploratory methods. Examines trial design treatment based on toxicity and survival! Featuring over 1000 references, more than 40 world-renowned contributors, and 300 equations, tables, and drawings, the Handbook of Statistics in Clinical Oncology provides a comprehensive discussion of sample size considers analytical problems generated by controlling treatment costs and maintaining quality of life demonstrates the breadth and depth of current activity in the field of survival analysis sets the limits on what can and cannot be concluded from single and multiple clinical trials and more! The best single source for up-to-date graphical, tree-based, and other statistical methods, the Handbook of Statistics in Clinical Oncology is fascinating reading for oncologists, cancer researchers, biostatisticians, applied statisticians, and medical and graduate students in these disciplines.
Author: Walter R. Young Publisher: CRC Press ISBN: 1482212188 Category : Mathematics Languages : en Pages : 582
Book Description
Since 1945, "The Annual Deming Conference on Applied Statistics" has been an important event in the statistics profession. In Clinical Trial Biostatistics and Biopharmaceutical Applications, prominent speakers from past Deming conferences present novel biostatistical methodologies in clinical trials as well as up-to-date biostatistical applications from the pharmaceutical industry. Divided into five sections, the book begins with emerging issues in clinical trial design and analysis, including the roles of modeling and simulation, the pros and cons of randomization procedures, the design of Phase II dose-ranging trials, thorough QT/QTc clinical trials, and assay sensitivity and the constancy assumption in noninferiority trials. The second section examines adaptive designs in drug development, discusses the consequences of group-sequential and adaptive designs, and illustrates group sequential design in R. The third section focuses on oncology clinical trials, covering competing risks, escalation with overdose control (EWOC) dose finding, and interval-censored time-to-event data. In the fourth section, the book describes multiple test problems with applications to adaptive designs, graphical approaches to multiple testing, the estimation of simultaneous confidence intervals for multiple comparisons, and weighted parametric multiple testing methods. The final section discusses the statistical analysis of biomarkers from omics technologies, biomarker strategies applicable to clinical development, and the statistical evaluation of surrogate endpoints. This book clarifies important issues when designing and analyzing clinical trials, including several misunderstood and unresolved challenges. It will help readers choose the right method for their biostatistical application. Each chapter is self-contained with references.
Author: Pradip Debnath Publisher: CRC Press ISBN: 1000409813 Category : Computers Languages : en Pages : 232
Book Description
Soft computing techniques are no longer limited to the arena of computer science. The discipline has an exponentially growing demand in other branches of science and engineering and even into health and social science. This book contains theory and applications of soft computing in engineering, health, and social and applied sciences. Different soft computing techniques such as artificial neural networks, fuzzy systems, evolutionary algorithms and hybrid systems are discussed. It also contains important chapters in machine learning and clustering. This book presents a survey of the existing knowledge and also the current state of art development through original new contributions from the researchers. This book may be used as a one-stop reference book for a broad range of readers worldwide interested in soft computing. In each chapter, the preliminaries have been presented first and then the advanced discussion takes place. Learners and researchers from a wide variety of backgrounds will find several useful tools and techniques to develop their soft computing skills. This book is meant for graduate students, faculty and researchers willing to expand their knowledge in any branch of soft computing. The readers of this book will require minimum prerequisites of undergraduate studies in computation and mathematics.