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Author : Gail E. Tudor
Publisher :
ISBN 13 :
Total Pages : 104 pages
Book Rating : 4.:/5 (245 download)
Download or read book Survival Analysis Using Primary and Surrogate Endpoints written by Gail E. Tudor and published by . This book was released on 1991 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Geert Molenberghs
Publisher : Springer Science & Business Media
ISBN 13 : 9780387202778
Total Pages : 440 pages
Book Rating : 4.2/5 (27 download)
Download or read book The Evaluation of Surrogate Endpoints written by Geert Molenberghs and published by Springer Science & Business Media. This book was released on 2005-02-28 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers the latest research on a sensitive and controversial topic in a professional and well researched manner. Provides practical outlook as well as model guidelines and software tools that should be of interest to people who use the software tools described and those who do not. Related title by Co-author Geert Molenbergh has sold more than 3500 copies world wide. Provides dual viewpoints: from scientists in the industry as well as regulatory authorities.
Author : Tomasz Burzykowski
Publisher : Springer Science & Business Media
ISBN 13 : 0387270809
Total Pages : 417 pages
Book Rating : 4.3/5 (872 download)
Download or read book The Evaluation of Surrogate Endpoints written by Tomasz Burzykowski and published by Springer Science & Business Media. This book was released on 2005-11-24 with total page 417 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers the latest research on a sensitive and controversial topic in a professional and well researched manner. Provides practical outlook as well as model guidelines and software tools that should be of interest to people who use the software tools described and those who do not. Related title by Co-author Geert Molenbergh has sold more than 3500 copies world wide. Provides dual viewpoints: from scientists in the industry as well as regulatory authorities.
Author : Stephanie Green
Publisher : CRC Press
ISBN 13 : 1439814481
Total Pages : 266 pages
Book Rating : 4.4/5 (398 download)
Download or read book Clinical Trials in Oncology, Third Edition written by Stephanie Green and published by CRC Press. This book was released on 2012-05-09 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. In addition, the book has been restructured to have separate chapters and expanded discussions on general clinical trials issues, and issues specific to Phases I, II, and III. New sections cover innovations in Phase I designs, randomized Phase II designs, and overcoming the challenges of array data. Although this book focuses on cancer trials, the same issues and concepts are important in any clinical setting. As always, the authors use clear, lucid prose and a multitude of real-world examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Armed with Clinical Trials in Oncology, Third Edition, clinicians and statisticians can avoid the many hazards that can jeopardize the success of a trial.
Author : Takeshi Emura
Publisher : Springer
ISBN 13 : 9811335168
Total Pages : 118 pages
Book Rating : 4.8/5 (113 download)
Download or read book Survival Analysis with Correlated Endpoints written by Takeshi Emura and published by Springer. This book was released on 2019-03-25 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book introduces readers to advanced statistical methods for analyzing survival data involving correlated endpoints. In particular, it describes statistical methods for applying Cox regression to two correlated endpoints by accounting for dependence between the endpoints with the aid of copulas. The practical advantages of employing copula-based models in medical research are explained on the basis of case studies. In addition, the book focuses on clustered survival data, especially data arising from meta-analysis and multicenter analysis. Consequently, the statistical approaches presented here employ a frailty term for heterogeneity modeling. This brings the joint frailty-copula model, which incorporates a frailty term and a copula, into a statistical model. The book also discusses advanced techniques for dealing with high-dimensional gene expressions and developing personalized dynamic prediction tools under the joint frailty-copula model. To help readers apply the statistical methods to real-world data, the book provides case studies using the authors’ original R software package (freely available in CRAN). The emphasis is on clinical survival data, involving time-to-tumor progression and overall survival, collected on cancer patients. Hence, the book offers an essential reference guide for medical statisticians and provides researchers with advanced, innovative statistical tools. The book also provides a concise introduction to basic multivariate survival models.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309157277
Total Pages : 335 pages
Book Rating : 4.3/5 (91 download)
Download or read book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease written by Institute of Medicine and published by National Academies Press. This book was released on 2010-06-25 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.
Author : David Machin
Publisher : John Wiley & Sons
ISBN 13 : 0470870419
Total Pages : 278 pages
Book Rating : 4.4/5 (78 download)
Download or read book Survival Analysis written by David Machin and published by John Wiley & Sons. This book was released on 2006-03-30 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: Well received in its first edition, Survival Analysis: A Practical Approach is completely revised to provide an accessible and practical guide to survival analysis techniques in diverse environments. Illustrated with many authentic examples, the book introduces basic statistical concepts and methods to construct survival curves, later developing them to encompass more specialised and complex models. During the years since the first edition there have been several new topics that have come to the fore and many new applications. Parallel developments in computer software programmes, used to implement these methodologies, are relied upon throughout the text to bring it up to date.
Author : Jianrong Wu
Publisher : CRC Press
ISBN 13 : 0429892934
Total Pages : 243 pages
Book Rating : 4.4/5 (298 download)
Download or read book Statistical Methods for Survival Trial Design written by Jianrong Wu and published by CRC Press. This book was released on 2018-06-14 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Ariel Alonso
Publisher : CRC Press
ISBN 13 : 1482249375
Total Pages : 396 pages
Book Rating : 4.4/5 (822 download)
Download or read book Applied Surrogate Endpoint Evaluation Methods with SAS and R written by Ariel Alonso and published by CRC Press. This book was released on 2016-11-30 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: An important factor that affects the duration, complexity and cost of a clinical trial is the endpoint used to study the treatment’s efficacy. When a true endpoint is difficult to use because of such factors as long follow-up times or prohibitive cost, it is sometimes possible to use a surrogate endpoint that can be measured in a more convenient or cost-effective way. This book focuses on the use of surrogate endpoint evaluation methods in practice, using SAS and R.
Author : Giuseppe Giaccone
Publisher : CRC Press
ISBN 13 : 1842145452
Total Pages : 500 pages
Book Rating : 4.8/5 (421 download)
Download or read book Targeted Therapies in Oncology, Second Edition written by Giuseppe Giaccone and published by CRC Press. This book was released on 2013-10-21 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the last edition of this book, major advances have been made in our understanding of key pathways that control tumor progression. This has led to the development of new anticancer agents that have the ability to block the activity of proteins involved in neoplastic cell development and proliferation. Targeted Therapies in Oncology, Second Edition provides a concise timely panorama of existing targeted therapies and progress into future anticancer treatments. These therapies notably include: Targeted agents of immune checkpoints Signal-transduction inhibitors Antiangiogenic agents Vascular-disrupting agents Apoptosis modulators Stem cell inhibitors Tumor profiling for drug development The book emphasizes the biology behind this new class of drugs as well as the clinical achievements obtained. The contributors to this volume stand at the cutting edge of cancer research and treatment around the world.
Author : Lawrence M. Friedman
Publisher : Springer Science & Business Media
ISBN 13 : 9780387985862
Total Pages : 384 pages
Book Rating : 4.9/5 (858 download)
Download or read book Fundamentals of Clinical Trials written by Lawrence M. Friedman and published by Springer Science & Business Media. This book was released on 1998 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.
Author : Alison L. Pedley
Publisher :
ISBN 13 :
Total Pages : 210 pages
Book Rating : 4.:/5 (728 download)
Download or read book Applying Survival Analysis Techniques to Interim Analysis and Sample Size Reassessment of Clinical Trials with a Dichotomous Endpoint written by Alison L. Pedley and published by . This book was released on 2011 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: Abstract: A two-sample Z test of proportions is often performed in randomized clinical trials designed to assess the superiority of an experimental treatment to a control with respect to a long-term dichotomous primary endpoint, such as 1-year mortality. Due to the staggered entry of participants across the trial's recruitment period, only a portion of enrolled participants have complete follow- up data available at the time of an interim analysis. Typically, the interim evaluation of trial hypotheses is performed using the same test statistic as the test statistic planned for the final analysis. However, application of the Z test of proportions at interim analysis results in a potentially substantial reduction to the number of participants that are able to contribute to the analysis. In this dissertation, methodology for the use of the log-rank test, which incorporates data of all enrolled participants regardless of the amount of time each has been followed, in the interim analysis of trials with a dichotomous final primary endpoint is developed and evaluated. Although the overall power and type I error rates of the newly proposed methodology and the standard methodology are comparable under the assumption of proportional hazards and event rates less than 50%, the efficiency of using the log-rank test during the interim analysis was realized in terms of an increased probability of early trial termination for overwhelming efficacy resulting in potential for shorter trials and smaller sized trials. Methodology for using the log-rank test was also developed for and applied to trials incorporating an adaptation for sample size re-estimation at interim based on the conditional power of achieving a significant result by the end of the trial. In the context of sample size re-estimation, the use of the log-rank test not only increased the probability of declaring superiority of the experimental treatment over the control at the time of interim analysis, but increased the overall power. Regardless of whether or not sample size re-estimation is used, greater efficiency is attained when the log-rank test is performed at interim analysis as the differential between the percentages of subjects enrolled and with complete follow-up at interim analysis increases.
Author : Mara Tableman
Publisher : CRC Press
ISBN 13 : 0203501411
Total Pages : 277 pages
Book Rating : 4.2/5 (35 download)
Download or read book Survival Analysis Using S written by Mara Tableman and published by CRC Press. This book was released on 2003-07-28 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Survival Analysis Using S: Analysis of Time-to-Event Data is designed as a text for a one-semester or one-quarter course in survival analysis for upper-level or graduate students in statistics, biostatistics, and epidemiology. Prerequisites are a standard pre-calculus first course in probability and statistics, and a course in applied linear regression models. No prior knowledge of S or R is assumed. A wide choice of exercises is included, some intended for more advanced students with a first course in mathematical statistics. The authors emphasize parametric log-linear models, while also detailing nonparametric procedures along with model building and data diagnostics. Medical and public health researchers will find the discussion of cut point analysis with bootstrap validation, competing risks and the cumulative incidence estimator, and the analysis of left-truncated and right-censored data invaluable. The bootstrap procedure checks robustness of cut point analysis and determines cut point(s). In a chapter written by Stephen Portnoy, censored regression quantiles - a new nonparametric regression methodology (2003) - is developed to identify important forms of population heterogeneity and to detect departures from traditional Cox models. By generalizing the Kaplan-Meier estimator to regression models for conditional quantiles, this methods provides a valuable complement to traditional Cox proportional hazards approaches.
Author : Vinayak K. Prasad
Publisher : JHU Press
ISBN 13 : 1421417723
Total Pages : 276 pages
Book Rating : 4.4/5 (214 download)
Download or read book Ending Medical Reversal written by Vinayak K. Prasad and published by JHU Press. This book was released on 2015-11 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medications such as Vioxx and procedures such as vertebroplasty for back pain are among the medical "advances" that turned out to be dangerous or useless. What Dr. Vinayak K. Prasad and Dr. Adam S. Cifu call medical reversal happens when doctors start using a medication, procedure, or diagnostic tool without a robust evidence base—and then stop using it when it is found not to help, or even to harm, patients. In Ending Medical Reversal, Drs. Prasad and Cifu narrate fascinating stories from every corner of medicine to explore why medical reversals occur, how they are harmful, and what can be done to avoid them. They explore the difference between medical innovations that improve care and those that only appear to be promising. They also outline a comprehensive plan to reform medical education, research funding and protocols, and the process for approving new drugs that will ensure that more of what gets done in doctors' offices and hospitals is truly effective. "Every doctor should read this book."—JAMA Internal Medicine "[A]n excellent and realistic discussion of some of the horror stories that occur in medical practice . . . Highly recommended."—Choice "Ending Medical Reversal goes far in teaching medical students and practicing physicians alike how to learn on our own."—The Lancet "This has to be on the reading list for medical and nursing students."—Nursing Times "Ending Medical Reversal presents persuasive evidence that many current standard-of-care treatments are probably ineffective or harmful, thoroughly explains how such treatments came to be accepted, and proposes a number of ways to address the general problem (only some of which involve avaricious companies and mercenary physicians) and minimize its impact on a specific patient."—Journal of Clinical Research Best Practices "Dr. Prasad and Dr. Cifu offer a five-step plan, including pointers for determining if a given treatment is really able to do what you want it to do, and advice on finding a like-minded doctor who won't object to a certain amount of back-seat driving."—The New York Times "When I describe Ending Medical Reversal as revolutionary, I don't use the term lightly. Go out and read it—right now."—Common Sense Family Doctor "Should be considered for undergraduate reading lists. Keep a copy in the pharmacy or your briefcase as a great icebreaker or discussion point with other local healthcare professionals."—The Pharmaceutical Journal
Author : Tom Brody
Publisher : Academic Press
ISBN 13 : 0128042583
Total Pages : 897 pages
Book Rating : 4.1/5 (28 download)
Download or read book Clinical Trials written by Tom Brody and published by Academic Press. This book was released on 2016-02-19 with total page 897 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers
Author : Kamal M.F. Itani
Publisher : Springer
ISBN 13 : 3319538772
Total Pages : 485 pages
Book Rating : 4.3/5 (195 download)
Download or read book Clinical Trials Design in Operative and Non Operative Invasive Procedures written by Kamal M.F. Itani and published by Springer. This book was released on 2017-05-16 with total page 485 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of this text is to provide the framework for building a clinical trial as it pertains to operative and non operative invasive procedures, how to get it funded and how to conduct such a trial up to publication of results The text provides all details of building a scientifically and ethically valid proposal, including how to build the infrastructure for a clinical trial and how to move it forward through various funding agencies. The text also presents various types of clinical trials, the use of implantable devices and FDA requirements, and adjuncts to clinical trials and interaction with industry Clinical Trials Design in Invasive Operative and Non Operative Procedures will be of interest to all specialists of surgery, anesthesiologists, interventional radiologists, gastroenterologists, cardiologists, and pulmonologists
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
