An Introduction To Statistics In Early Phase Trials
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An Introduction To Statistics In Early Phase Trials
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Author : Steven Julious
language : en
Publisher: John Wiley & Sons
Release Date : 2010-01-19
An Introduction To Statistics In Early Phase Trials written by Steven Julious and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-01-19 with Medical categories.
All new medicines and devices undergo early phase trials to assess, interpret and better understand their efficacy, tolerability and safety. An Introduction to Statistics in Early Phase Trials describes the practical design and analysis of these important early phase clinical trials and provides the crucial statistical basis for their interpretation. It clearly and concisely provides an overview of the most common types of trials undertaken in early phase clinical research and explains the different methodologies used. The impact of statistical technologies on clinical development and the statistical and methodological basis for making clinical and investment decisions are also explained. Conveys key ideas in a concise manner understandable by non-statisticians Explains how to optimise designs in a constrained or fixed resource setting Discusses decision making criteria at the end of Phase II trials Highlights practical day-to-day issues and reporting of early phase trials An Introduction to Statistics in Early Phase Trials is an essential guide for all researchers working in early phase clinical trial development, from clinical pharmacologists and pharmacokineticists through to clinical investigators and medical statisticians. It is also a valuable reference for teachers and students of pharmaceutical medicine learning about the design and analysis of clinical trials.
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 statistical topics relevant to the design, monitoring, and analysis of a clinical trial. After reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, presents methods for determining sample size, and introduces constrained randomization procedures. The authors also discuss how various types of data must be collected to answer key questions in a trial. In addition, they explore common analysis methods, describe statistical methods that determine what an emerging trend represents, and present issues that arise in the analysis of data. The book concludes with suggestions for reporting trial results that are consistent with universal guidelines recommended by medical journals. Developed from a course taught at the University of Wisconsin for the past 25 years, this textbook provides a solid understanding of the statistical approaches used in the design, conduct, and analysis of clinical trials.
Dose Finding Designs For Early Phase Cancer Clinical Trials
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Author : Takashi Daimon
language : en
Publisher: Springer
Release Date : 2019-05-21
Dose Finding Designs For Early Phase Cancer Clinical Trials written by Takashi Daimon and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-05-21 with Medical categories.
This book provides a comprehensive introduction to statistical methods for designing early phase dose-finding clinical trials. It will serve as a textbook or handbook for graduate students and practitioners in biostatistics and clinical investigators who are involved in designing, conducting, monitoring, and analyzing dose-finding trials. The book will also provide an overview of advanced topics and discussions in this field for the benefit of researchers in biostatistics and statistical science. Beginning with backgrounds and fundamental notions on dose finding in early phase clinical trials, the book then provides traditional and recent dose-finding designs of phase I trials for, e.g., cytotoxic agents in oncology, to evaluate toxicity outcome. Included are rule-based and model-based designs, such as 3 + 3 designs, accelerated titration designs, toxicity probability interval designs, continual reassessment method and related designs, and escalation overdose control designs. This book also covers more complex and updated dose-finding designs of phase I-II and I/II trials for cytotoxic agents, and cytostatic agents, focusing on both toxicity and efficacy outcomes, such as designs with covariates and drug combinations, maximum tolerated dose-schedule finding designs, and so on.
Methods And Applications Of Statistics In Clinical Trials Volume 1 And Volume 2
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Author : Narayanaswamy Balakrishnan
language : en
Publisher: Wiley
Release Date : 2014-05-27
Methods And Applications Of Statistics In Clinical Trials Volume 1 And Volume 2 written by Narayanaswamy Balakrishnan and has been published by Wiley this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-05-27 with Medical categories.
This set includes Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs & Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods. Volume 1 Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs successfully upholds the goals of the Wiley Encyclopedia of Clinical Trials by combining both previously-published and newly developed contributions written by over 100 leading academics, researchers, and practitioners in a comprehensive, approachable format. The result is a succinct reference that unveils modern, cutting-edge approaches to acquiring and understanding data throughout the various stages of clinical trial design and analysis. Volume 2 Featuring newly-written material as well as established literature from the Wiley Encyclopedia of Clinical Trials, this book provides a timely and authoritative review of techniques for planning clinical trials as well as the necessary inferential methods for analyzing collected data. This comprehensive volume features established and newly-written literature on the key statistical principles and concepts for designing modern-day clinical trials, such as hazard ratio, flexible designs, confounding, covariates, missing data, and longitudinal data. Examples of ongoing, cutting-edge clinical trials from today's research such as early cancer & heart disease, mother to child human immunodeficiency virus transmission, women's health initiative dietary, and AIDS clinical trials are also explored.
Clinical Trial Design
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Author : Guosheng Yin
language : en
Publisher: John Wiley & Sons
Release Date : 2013-06-07
Clinical Trial Design written by Guosheng Yin and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-06-07 with Medical categories.
A balanced treatment of the theories, methodologies, and design issues involved in clinical trials using statistical methods There has been enormous interest and development in Bayesian adaptive designs, especially for early phases of clinical trials. However, for phase III trials, frequentist methods still play a dominant role through controlling type I and type II errors in the hypothesis testing framework. From practical perspectives, Clinical Trial Design: Bayesian and Frequentist Adaptive Methods provides comprehensive coverage of both Bayesian and frequentist approaches to all phases of clinical trial design. Before underpinning various adaptive methods, the book establishes an overview of the fundamentals of clinical trials as well as a comparison of Bayesian and frequentist statistics. Recognizing that clinical trial design is one of the most important and useful skills in the pharmaceutical industry, this book provides detailed discussions on a variety of statistical designs, their properties, and operating characteristics for phase I, II, and III clinical trials as well as an introduction to phase IV trials. Many practical issues and challenges arising in clinical trials are addressed. Additional topics of coverage include: Risk and benefit analysis for toxicity and efficacy trade-offs Bayesian predictive probability trial monitoring Bayesian adaptive randomization Late onset toxicity and response Dose finding in drug combination trials Targeted therapy designs The author utilizes cutting-edge clinical trial designs and statistical methods that have been employed at the world's leading medical centers as well as in the pharmaceutical industry. The software used throughout the book is freely available on the book's related website, equipping readers with the necessary tools for designing clinical trials. Clinical Trial Design is an excellent book for courses on the topic at the graduate level. The book also serves as a valuable reference for statisticians and biostatisticians in the pharmaceutical industry as well as for researchers and practitioners who design, conduct, and monitor clinical trials in their everyday work.
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.
Methods And Applications Of Statistics In Clinical Trials Volume 1
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Author : Narayanaswamy Balakrishnan
language : en
Publisher: John Wiley & Sons
Release Date : 2014-03-05
Methods And Applications Of Statistics In Clinical Trials Volume 1 written by Narayanaswamy Balakrishnan and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-03-05 with Medical categories.
A complete guide to the key statistical concepts essential for the design and construction of clinical trials As the newest major resource in the field of medical research, Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs presents a timely and authoritative reviewof the central statistical concepts used to build clinical trials that obtain the best results. The referenceunveils modern approaches vital to understanding, creating, and evaluating data obtained throughoutthe various stages of clinical trial design and analysis. Accessible and comprehensive, the first volume in a two-part set includes newly-written articles as well as established literature from the Wiley Encyclopedia of Clinical Trials. Illustrating a variety of statistical concepts and principles such as longitudinal data, missing data, covariates, biased-coin randomization, repeated measurements, and simple randomization, the book also provides in-depth coverage of the various trial designs found within phase I-IV trials. Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs also features: Detailed chapters on the type of trial designs, such as adaptive, crossover, group-randomized, multicenter, non-inferiority, non-randomized, open-labeled, preference, prevention, and superiority trials Over 100 contributions from leading academics, researchers, and practitioners An exploration of ongoing, cutting-edge clinical trials on early cancer and heart disease, mother-to-child human immunodeficiency virus transmission trials, and the AIDS Clinical Trials Group Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs is an excellent reference for researchers, practitioners, and students in the fields of clinicaltrials, pharmaceutics, biostatistics, medical research design, biology, biomedicine, epidemiology,and public health.
Handbook Of Methods For Designing Monitoring And Analyzing Dose Finding Trials
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Author : John O'Quigley
language : en
Publisher: CRC Press
Release Date : 2017-04-27
Handbook Of Methods For Designing Monitoring And Analyzing Dose Finding Trials written by John O'Quigley and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-04-27 with Mathematics categories.
Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials gives a thorough presentation of state-of-the-art methods for early phase clinical trials. The methodology of clinical trials has advanced greatly over the last 20 years and, arguably, nowhere greater than that of early phase studies. The need to accelerate drug development in a rapidly evolving context of targeted therapies, immunotherapy, combination treatments and complex group structures has provided the stimulus to these advances. Typically, we deal with very small samples, sequential methods that need to be efficient, while, at the same time adhering to ethical principles due to the involvement of human subjects. Statistical inference is difficult since the standard techniques of maximum likelihood do not usually apply as a result of model misspecification and parameter estimates lying on the boundary of the parameter space. Bayesian methods play an important part in overcoming these difficulties, but nonetheless, require special consideration in this particular context. The purpose of this handbook is to provide an expanded summary of the field as it stands and also, through discussion, provide insights into the thinking of leaders in the field as to the potential developments of the years ahead. With this goal in mind we present: An introduction to the field for graduate students and novices A basis for more established researchers from which to build A collection of material for an advanced course in early phase clinical trials A comprehensive guide to available methodology for practicing statisticians on the design and analysis of dose-finding experiments An extensive guide for the multiple comparison and modeling (MCP-Mod) dose-finding approach, adaptive two-stage designs for dose finding, as well as dose–time–response models and multiple testing in the context of confirmatory dose-finding studies. John O’Quigley is a professor of mathematics and research director at the French National Institute for Health and Medical Research based at the Faculty of Mathematics, University Pierre and Marie Curie in Paris, France. He is author of Proportional Hazards Regression and has published extensively in the field of dose finding. Alexia Iasonos is an associate attending biostatistician at the Memorial Sloan Kettering Cancer Center in New York. She has over one hundred publications in the leading statistical and clinical journals on the methodology and design of early phase clinical trials. Dr. Iasonos has wide experience in the actual implementation of model based early phase trials and has given courses in scientific meetings internationally. Björn Bornkamp is a statistical methodologist at Novartis in Basel, Switzerland, researching and implementing dose-finding designs in Phase II clinical trials. He is one of the co-developers of the MCP-Mod methodology for dose finding and main author of the DoseFinding R package. He has published numerous papers on dose finding, nonlinear models and Bayesian statistics, and in 2013 won the Royal Statistical Society award for statistical excellence in the pharmaceutical industry.
Introduction To Randomized Controlled Clinical Trials
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Author : John N.S. Matthews
language : en
Publisher: CRC Press
Release Date : 2006-06-26
Introduction To Randomized Controlled Clinical Trials written by John N.S. Matthews and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-06-26 with Mathematics categories.
Evidence from randomized controlled clinical trials is widely accepted as the only sound basis for assessing the efficacy of new medical treatments. Statistical methods play a key role in all stages of these trials, including their justification, design, and analysis. This second edition of Introduction to Randomized Controlled Clinical Trials prov
Sample Sizes For Clinical Trials
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Author : Steven A. Julious
language : en
Publisher: CRC Press
Release Date : 2009-08-26
Sample Sizes For Clinical Trials written by Steven A. Julious and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-08-26 with Mathematics categories.
Drawing on various real-world applications, Sample Sizes for Clinical Trials takes readers through the process of calculating sample sizes for many types of clinical trials. It provides descriptions of the calculations with a practical emphasis.Focusing on normal, binary, ordinal, and survival data, the book explores a range of trials, including su