Statistical Methods For Survival Trial Design
Download Statistical Methods For Survival Trial Design full books in PDF, epub, and Kindle. Read online free Statistical Methods For Survival Trial Design ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!
| Author | : Jianrong Wu |
| Publisher | : CRC Press |
| Total Pages | : 243 |
| Release | : 2018-06-14 |
| Genre | : Mathematics |
| ISBN | : 0429892934 |
Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R provides a thorough presentation of the principles of designing and monitoring cancer clinical trials in which time-to-event is the primary endpoint. Traditional cancer trial designs with time-to-event endpoints are often limited to the exponential model or proportional hazards model. In practice, however, those model assumptions may not be satisfied for long-term survival trials. This book is the first to cover comprehensively the many newly developed methodologies for survival trial design, including trial design under the Weibull survival models; extensions of the sample size calculations under the proportional hazard models; and trial design under mixture cure models, complex survival models, Cox regression models, and competing-risk models. A general sequential procedure based on the sequential conditional probability ratio test is also implemented for survival trial monitoring. All methodologies are presented with sufficient detail for interested researchers or graduate students.
| Author | : Jianrong Wu |
| Publisher | : CRC Press |
| Total Pages | : 273 |
| Release | : 2021-07-19 |
| Genre | : Mathematics |
| ISBN | : 1000421732 |
Single-Arm Phase II Survival Trial Design provides a comprehensive summary to the most commonly- used methods for single-arm phase II trial design with time-to-event endpoints. Single-arm phase II trials are a key component for successfully developing advanced cancer drugs and treatments, particular for target therapy and immunotherapy in which time-to-event endpoints are often the primary endpoints. Most test statistics for single-arm phase II trial design with time-to-event endpoints are not available in commercial software. Key Features: Covers the most frequently used methods for single-arm phase II trial design with time-to-event endpoints in a comprehensive fashion. Provides new material on phase II immunotherapy trial design and phase II trial design with TTP ratio endpoint. Illustrates trial designs by real clinical trial examples Includes R code for all methods proposed in the book, enabling straightforward sample size calculation.
| Author | : Thomas D. Cook |
| Publisher | : CRC Press |
| Total Pages | : 465 |
| Release | : 2007-11-19 |
| Genre | : Mathematics |
| ISBN | : 1584880279 |
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.
| Author | : Weichung Joe Shih |
| Publisher | : CRC Press |
| Total Pages | : 320 |
| Release | : 2021-10-26 |
| Genre | : Medical |
| ISBN | : 1000462811 |
Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters. Developed from the authors’ courses taught to public health and medical students, residents, and fellows during the past 20 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, phase 2/3 seamless design and trials with predictive biomarkers, exploit multiple testing procedures, and explain the concept of estimand, intercurrent events, and different missing data processes, and describe how to analyze incomplete data by proper multiple imputations. This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of trials. The book’s balanced set of homework assignments and in-class exercises are appropriate for students and researchers in (bio)statistics, epidemiology, medicine, pharmacy, and public health.
| Author | : Yanning Liu |
| Publisher | : |
| Total Pages | : 248 |
| Release | : 2017-01-11 |
| Genre | : |
| ISBN | : 9783659845543 |
| Author | : Elisa T. Lee |
| Publisher | : John Wiley & Sons |
| Total Pages | : 0 |
| Release | : 2013-10-07 |
| Genre | : Mathematics |
| ISBN | : 9781118095027 |
Praise for the Third Edition “. . . an easy-to read introduction to survival analysis which covers the major concepts and techniques of the subject.” —Statistics in Medical Research Updated and expanded to reflect the latest developments, Statistical Methods for Survival Data Analysis, Fourth Edition continues to deliver a comprehensive introduction to the most commonly-used methods for analyzing survival data. Authored by a uniquely well-qualified author team, the Fourth Edition is a critically acclaimed guide to statistical methods with applications in clinical trials, epidemiology, areas of business, and the social sciences. The book features many real-world examples to illustrate applications within these various fields, although special consideration is given to the study of survival data in biomedical sciences. Emphasizing the latest research and providing the most up-to-date information regarding software applications in the field, Statistical Methods for Survival Data Analysis, Fourth Edition also includes: Marginal and random effect models for analyzing correlated censored or uncensored data Multiple types of two-sample and K-sample comparison analysis Updated treatment of parametric methods for regression model fitting with a new focus on accelerated failure time models Expanded coverage of the Cox proportional hazards model Exercises at the end of each chapter to deepen knowledge of the presented material Statistical Methods for Survival Data Analysis is an ideal text for upper-undergraduate and graduate-level courses on survival data analysis. The book is also an excellent resource for biomedical investigators, statisticians, and epidemiologists, as well as researchers in every field in which the analysis of survival data plays a role.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 221 |
| Release | : 2001-01-01 |
| Genre | : Medical |
| ISBN | : 0309171148 |
Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
| Author | : Elisa T. Lee |
| Publisher | : Wiley-Interscience |
| Total Pages | : 504 |
| Release | : 1992-05-07 |
| Genre | : Mathematics |
| ISBN | : |
Functions of survival time; Examples of survival data analysis; Nonparametric methods of estimating survival functions; Nonparametric methods for comparing survival distributions; Some well-known survival distributions and their applications; Graphical methods for sulvival distribution fitting and goodness-of-fit tests; Analytical estimation procedures for sulvival distributions; Parametric methods for comparing two survival distribution; Identification of prognostic factors related to survival time; Identification of risk factors related to dichotomous data; Planning and design of clinical trials (I); Planning and design of clinicL trials(II).
| Author | : Regina C. Elandt-Johnson |
| Publisher | : John Wiley & Sons |
| Total Pages | : 490 |
| Release | : 1980-09-17 |
| Genre | : Mathematics |
| ISBN | : 9780471031741 |
Survival analysis deals with the distribution of life times, essentially the times from an initiating event such as birth or the start of a job to some terminal event such as death or pension. This book, originally published in 1980, surveys and analyzes methods that use survival measurements and concepts, and helps readers apply the appropriate method for a given situation. Four broad sections cover introductions to data, univariate survival function, multiple-failure data, and advanced topics.
| Author | : Thomas D. Cook |
| Publisher | : CRC Press |
| Total Pages | : 465 |
| Release | : 2007-11-19 |
| Genre | : Mathematics |
| ISBN | : 1584880279 |
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.
