Statistical Approaches In Oncology Clinical Development

Statistical Approaches in Oncology Clinical Development PDF
Author: Satrajit Roychoudhury
Publisher: CRC Press
ISBN: 1351650475
Size: 30.12 MB
Format: PDF, ePub, Mobi
Category : Mathematics
Languages : en
Pages : 220
View: 7550

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Book Description:

Statistical Approaches In Oncology Clinical Development

by Satrajit Roychoudhury, Statistical Approaches In Oncology Clinical Development Book available in PDF, EPUB, Mobi Format. Download Statistical Approaches In Oncology Clinical Development books, 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.







Textbook Of Clinical Trials In Oncology

Textbook of Clinical Trials in Oncology PDF
Author: Susan Halabi
Publisher: CRC Press
ISBN: 1351620975
Size: 29.43 MB
Format: PDF, ePub, Mobi
Category : Medical
Languages : en
Pages : 626
View: 5907

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Book Description:

Textbook Of Clinical Trials In Oncology

by Susan Halabi, Textbook Of Clinical Trials In Oncology Book available in PDF, EPUB, Mobi Format. Download Textbook Of Clinical Trials In Oncology books, 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







Statistical Methods For Evaluating Safety In Medical Product Development

Statistical Methods for Evaluating Safety in Medical Product Development PDF
Author: A. Lawrence Gould
Publisher: John Wiley & Sons
ISBN: 1118763092
Size: 70.35 MB
Format: PDF
Category : Medical
Languages : en
Pages : 392
View: 5934

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Book Description:

Statistical Methods For Evaluating Safety In Medical Product Development

by A. Lawrence Gould, Statistical Methods For Evaluating Safety In Medical Product Development Book available in PDF, EPUB, Mobi Format. Download Statistical Methods For Evaluating Safety In Medical Product Development books, This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. Provides a guide to statistical methods and application in medical product development Assists readers in undertaking design and analysis of experiments at various stages of product development Features case studies throughout the book, as well as, SAS and R code







Phase 1 Cancer Clinical Trials

Phase 1 Cancer Clinical Trials PDF
Author: Elizabeth A. Eisenhauer
Publisher: Oxford University Press, USA
ISBN:
Size: 17.65 MB
Format: PDF, ePub
Category : Medical
Languages : en
Pages : 343
View: 7706

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Book Description:

Phase 1 Cancer Clinical Trials

by Elizabeth A. Eisenhauer, Phase 1 Cancer Clinical Trials Book available in PDF, EPUB, Mobi Format. Download Phase 1 Cancer Clinical Trials books, Phase I trials are the first step in the study of novel therapeutic approaches. They aim to identify the recommended dose, schedule and pharamcologic behaviour of new drugs, and to describe the adverse effects of treatment. This practical guide discusses the design, conduct, analysis and ethical aspects of Phase I cancer trials.







Research Awards Index

Research Awards Index PDF
Author:
Publisher:
ISBN:
Size: 37.77 MB
Format: PDF, ePub, Docs
Category : Medicine
Languages : en
Pages :
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Book Description:

Research Awards Index

by , Research Awards Index Book available in PDF, EPUB, Mobi Format. Download Research Awards Index books,







Clinical Trial Biostatistics And Biopharmaceutical Applications

Clinical Trial Biostatistics and Biopharmaceutical Applications PDF
Author: Walter R. Young
Publisher: CRC Press
ISBN: 1482212188
Size: 44.52 MB
Format: PDF, ePub, Mobi
Category : Mathematics
Languages : en
Pages : 580
View: 4528

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Book Description:

Clinical Trial Biostatistics And Biopharmaceutical Applications

by Walter R. Young, Clinical Trial Biostatistics And Biopharmaceutical Applications Book available in PDF, EPUB, Mobi Format. Download Clinical Trial Biostatistics And Biopharmaceutical Applications books, 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.







Modern Approaches To Clinical Trials Using Sas

Modern Approaches to Clinical Trials Using SAS PDF
Author: Sandeep Menon
Publisher: SAS Institute
ISBN: 1629600822
Size: 39.48 MB
Format: PDF, Mobi
Category : Computers
Languages : en
Pages : 364
View: 4984

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Book Description:

Modern Approaches To Clinical Trials Using Sas

by Sandeep Menon, Modern Approaches To Clinical Trials Using Sas Book available in PDF, EPUB, Mobi Format. Download Modern Approaches To Clinical Trials Using Sas books, Get the tools you need to use SAS® in clinical trial design! Unique and multifaceted, Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods, edited by Sandeep M. Menon and Richard C. Zink, thoroughly covers several domains of modern clinical trial design: classical, group sequential, adaptive, and Bayesian methods that are applicable to and widely used in various phases of pharmaceutical development. Written for biostatisticians, pharmacometricians, clinical developers, and statistical programmers involved in the design, analysis, and interpretation of clinical trials, as well as students in graduate and postgraduate programs in statistics or biostatistics, the book touches on a wide variety of topics, including dose-response and dose-escalation designs; sequential methods to stop trials early for overwhelming efficacy, safety, or futility; Bayesian designs that incorporate historical data; adaptive sample size re-estimation; adaptive randomization to allocate subjects to more effective treatments; and population enrichment designs. Methods are illustrated using clinical trials from diverse therapeutic areas, including dermatology, endocrinology, infectious disease, neurology, oncology, and rheumatology. Individual chapters are authored by renowned contributors, experts, and key opinion leaders from the pharmaceutical/medical device industry or academia. Numerous real-world examples and sample SAS code enable users to readily apply novel clinical trial design and analysis methodologies in practice.







Clinical Trials

Clinical Trials PDF
Author: Steven Piantadosi
Publisher: John Wiley & Sons
ISBN: 1118959205
Size: 60.97 MB
Format: PDF, Docs
Category : Mathematics
Languages : en
Pages : 920
View: 4138

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Book Description:

Clinical Trials

by Steven Piantadosi, Clinical Trials Book available in PDF, EPUB, Mobi Format. Download Clinical Trials books, Presents elements of clinical trial methods that are essential in planning, designing, conducting, analyzing, and interpreting clinical trials with the goal of improving the evidence derived from these important studies This Third Edition builds on the text’s reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials. Readers will encounter the principles of design for various types of clinical trials, and are then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides common sense solutions. All stages of therapeutic development are discussed in detail, and the methods are not restricted to a single clinical application area. The authors bases current revisions and updates on his own experience, classroom instruction, and feedback from teachers and medical and statistical professionals involved in clinical trials. The Third Edition greatly expands its coverage, ranging from statistical principles to new and provocative topics, including alternative medicine and ethics, middle development, comparative studies, and adaptive designs. At the same time, it offers more pragmatic advice for issues such as selecting outcomes, sample size, analysis, reporting, and handling allegations of misconduct. Readers familiar with the First and Second Editions will discover revamped exercise sets; an updated and extensive reference section; new material on endpoints and the developmental pipeline, among others; and revisions of numerous sections. In addition, this book: • Features accessible and broad coverage of statistical design methods—the crucial building blocks of clinical trials and medical research -- now complete with new chapters on overall development, middle development, comparative studies, and adaptive designs • Teaches readers to design clinical trials that produce valid qualitative results backed by rigorous statistical methods • Contains an introduction and summary in each chapter to reinforce key points • Includes discussion questions to stimulate critical thinking and help readers understand how they can apply their newfound knowledge • Provides extensive references to direct readers to the most recent literature, and there are numerous new or revised exercises throughout the book Clinical Trials: A Methodologic Perspective, Third Edition is a textbook accessible to advanced undergraduate students in the quantitative sciences, graduate students in public health and the life sciences, physicians training in clinical research methods, and biostatisticians and epidemiologists. This book is accompanied by downloadable files available below under the DOWNLOADS tab. These files include: MATHEMATICA program – A set of downloadable files that tracks the chapters, containing code pertaining to each. SAS PROGRAMS and DATA FILES used in the book. The following software programs, included in the downloadables, were developed by the author, Steven Piantadosi, M.D., Ph.D: RANDOMIZATION – This program generates treatment assignments for a clinical trial using blocked stratified randomization. CRM – Implements the continual reassessment methods for dose finding clinical trials. OPTIMAL – Calculates two-stage optimal phase II designs using the Simon method. POWER – This is a power and sample size program for clinical trials. Executables for installing these programs can also be found at https://risccweb.csmc.edu/biostats/. Steven Piantadosi, MD, PhD, is the Phase One Foundation Distinguished Chair and Director of the Samuel Oschin Cancer Institute, and Professor of Medicine at Cedars-Sinai Medical Center in Los Angeles, California. Dr. Piantadosi is one of the world’s leading experts in the design and analysis of clinical trials for cancer research. He has taught clinical trials methods extensively in formal courses and short venues. He has advised numerous academic programs and collaborations nationally regarding clinical trial design and conduct, and has served on external advisory boards for the National Institutes of Health and other prominent cancer programs and centers. The author of more than 260 peer-reviewed scientific articles, Dr. Piantadosi has published extensively on research results, clinical applications, and trial methodology. While his papers have contributed to many areas of oncology, he has also collaborated on diverse studies outside oncology including lung disease and degenerative neurological disease.







Statistical Methods For Dose Finding Experiments

Statistical Methods for Dose Finding Experiments PDF
Author: Sylvie Chevret
Publisher: Wiley-Blackwell
ISBN:
Size: 52.28 MB
Format: PDF
Category : Mathematics
Languages : en
Pages : 315
View: 4913

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Book Description:

Statistical Methods For Dose Finding Experiments

by Sylvie Chevret, Statistical Methods For Dose Finding Experiments Book available in PDF, EPUB, Mobi Format. Download Statistical Methods For Dose Finding Experiments books, Dose-finding experiments define the safe dosage of a drug in development, in terms of the quantity given to a patient. Statistical methods play a crucial role in identifying optimal dosage. Used appropriately, these methods provide reliable results and reduce trial duration and costs. In practice, however, dose-finding is often done poorly, with widely used conventional methods frequently being unreliable, leading to inaccurate results. However, there have been many advances in recent years, with new statistical techniques being developed and it is important that these new techniques are utilized correctly. Statistical Methods for Dose-Finding Experiments reviews the main statistical approaches for dose-finding in phase I/II clinical trials and presents practical guidance on their correct use. Includes an introductory section, summarizing the essential concepts in dose-finding. Contains a section on algorithm-based approaches, such as the traditional 3+3 design, and a section on model-based approaches, such as the continual reassessment method. Explains fundamental issues, such as how to stop trials early and how to cope with delayed or ordinal outcomes. Discusses in detail the main websites and software used to implement the methods. Features numerous worked examples making use of real data. Statistical Methods for Dose-Finding Experiments is an important collaboration from the leading experts in the area. Primarily aimed at statisticians and clinicians working in clinical trials and medical research, there is also much to benefit graduate students of biostatistics.