Likelihood Method For Randomized Time To Event Studies With All Or None Compliance

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Likelihood Method for Randomized Time-To-Event Studies with All-Or-None Compliance

Author : Zhaojing Gong
Publisher :
ISBN 13 : 9783668438637
Total Pages : 160 pages
Book Rating : 4.4/5 (386 download)

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Book Synopsis Likelihood Method for Randomized Time-To-Event Studies with All-Or-None Compliance by : Zhaojing Gong

Download or read book Likelihood Method for Randomized Time-To-Event Studies with All-Or-None Compliance written by Zhaojing Gong and published by . This book was released on 2017-04-28 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research Paper (postgraduate) from the year 2009 in the subject Statistics, grade: A, University of Canterbury (Department of Mathematics and Statistics), course: Statistics, language: English, abstract: Estimating causal effects in clinical trials often suffers from treatment non-compliance and missing outcomes. In time-to-event studies, it is more complicated because of censoring, the mechanism of which may be non-ignorable. While new estimators have recently been proposed to account for non-compliance and missing outcomes, few papers have specifically considered time-to-event outcomes, where even the intention-to-treat (ITT) estimator is potentially biased for estimating causal effects of assigned treatment. In this paper we develop a likelihood based method for randomized clinical trials (RCTs) with non-compliance for time-to-event data and adapt the EM algorithm according to derive the maximum likelihood estimators (MLEs). In addition, we give formulations of the average causal effect (ACE) and compliers average causal effect (CACE) to suit survival analysis. To illustrate the likelihood-based method (EM algorithm), a breast cancer trial data was re-analysed using a model, which assumes that the failure times and censored times both follow Weibull and Lognormal distributions, respectively (termed the NIGN-WW model and NIGN-LL model).

The Prevention and Treatment of Missing Data in Clinical Trials

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 030918651X
Total Pages : 163 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Prevention and Treatment of Missing Data in Clinical Trials by : National Research Council

Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Cochrane Handbook for Systematic Reviews of Interventions

Author : Julian P. T. Higgins
Publisher : Wiley
ISBN 13 : 9780470699515
Total Pages : 672 pages
Book Rating : 4.6/5 (995 download)

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Book Synopsis Cochrane Handbook for Systematic Reviews of Interventions by : Julian P. T. Higgins

Download or read book Cochrane Handbook for Systematic Reviews of Interventions written by Julian P. T. Higgins and published by Wiley. This book was released on 2008-11-24 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare providers, consumers, researchers and policy makers are inundated with unmanageable amounts of information, including evidence from healthcare research. It has become impossible for all to have the time and resources to find, appraise and interpret this evidence and incorporate it into healthcare decisions. Cochrane Reviews respond to this challenge by identifying, appraising and synthesizing research-based evidence and presenting it in a standardized format, published in The Cochrane Library (www.thecochranelibrary.com). The Cochrane Handbook for Systematic Reviews of Interventions contains methodological guidance for the preparation and maintenance of Cochrane intervention reviews. Written in a clear and accessible format, it is the essential manual for all those preparing, maintaining and reading Cochrane reviews. Many of the principles and methods described here are appropriate for systematic reviews applied to other types of research and to systematic reviews of interventions undertaken by others. It is hoped therefore that this book will be invaluable to all those who want to understand the role of systematic reviews, critically appraise published reviews or perform reviews themselves.

Handbook of Statistical Methods for Randomized Controlled Trials

Author : KyungMann Kim
Publisher : CRC Press
ISBN 13 : 1498714641
Total Pages : 655 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Handbook of Statistical Methods for Randomized Controlled Trials by : KyungMann Kim

Download or read book Handbook of Statistical Methods for Randomized Controlled Trials written by KyungMann Kim and published by CRC Press. This book was released on 2021-08-23 with total page 655 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical concepts provide scientific framework in experimental studies, including randomized controlled trials. In order to design, monitor, analyze and draw conclusions scientifically from such clinical trials, clinical investigators and statisticians should have a firm grasp of the requisite statistical concepts. The Handbook of Statistical Methods for Randomized Controlled Trials presents these statistical concepts in a logical sequence from beginning to end and can be used as a textbook in a course or as a reference on statistical methods for randomized controlled trials. Part I provides a brief historical background on modern randomized controlled trials and introduces statistical concepts central to planning, monitoring and analysis of randomized controlled trials. Part II describes statistical methods for analysis of different types of outcomes and the associated statistical distributions used in testing the statistical hypotheses regarding the clinical questions. Part III describes some of the most used experimental designs for randomized controlled trials including the sample size estimation necessary in planning. Part IV describe statistical methods used in interim analysis for monitoring of efficacy and safety data. Part V describe important issues in statistical analyses such as multiple testing, subgroup analysis, competing risks and joint models for longitudinal markers and clinical outcomes. Part VI addresses selected miscellaneous topics in design and analysis including multiple assignment randomization trials, analysis of safety outcomes, non-inferiority trials, incorporating historical data, and validation of surrogate outcomes.

Small Clinical Trials

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309171148
Total Pages : 221 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Small Clinical Trials by : Institute of Medicine

Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Issues in Bioengineering and Bioinformatics: 2013 Edition

Author :
Publisher : ScholarlyEditions
ISBN 13 : 149010867X
Total Pages : 1156 pages
Book Rating : 4.4/5 (91 download)

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Book Synopsis Issues in Bioengineering and Bioinformatics: 2013 Edition by :

Download or read book Issues in Bioengineering and Bioinformatics: 2013 Edition written by and published by ScholarlyEditions. This book was released on 2013-05-01 with total page 1156 pages. Available in PDF, EPUB and Kindle. Book excerpt: Issues in Bioengineering and Bioinformatics: 2013 Edition is a ScholarlyEditions™ book that delivers timely, authoritative, and comprehensive information about Lifetime Data Analysis. The editors have built Issues in Bioengineering and Bioinformatics: 2013 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Lifetime Data Analysis in this book to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Bioengineering and Bioinformatics: 2013 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.

Randomization in Clinical Trials

Author : William F. Rosenberger
Publisher : John Wiley & Sons
ISBN 13 : 1118742249
Total Pages : 284 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis Randomization in Clinical Trials by : William F. Rosenberger

Download or read book Randomization in Clinical Trials written by William F. Rosenberger and published by John Wiley & Sons. This book was released on 2015-11-23 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the First Edition “All medical statisticians involved in clinical trials should read this book...” - Controlled Clinical Trials Featuring a unique combination of the applied aspects of randomization in clinical trials with a nonparametric approach to inference, Randomization in Clinical Trials: Theory and Practice, Second Edition is the go-to guide for biostatisticians and pharmaceutical industry statisticians. Randomization in Clinical Trials: Theory and Practice, Second Edition features: Discussions on current philosophies, controversies, and new developments in the increasingly important role of randomization techniques in clinical trials A new chapter on covariate-adaptive randomization, including minimization techniques and inference New developments in restricted randomization and an increased focus on computation of randomization tests as opposed to the asymptotic theory of randomization tests Plenty of problem sets, theoretical exercises, and short computer simulations using SAS® to facilitate classroom teaching, simplify the mathematics, and ease readers’ understanding Randomization in Clinical Trials: Theory and Practice, Second Edition is an excellent reference for researchers as well as applied statisticians and biostatisticians. The Second Edition is also an ideal textbook for upper-undergraduate and graduate-level courses in biostatistics and applied statistics. William F. Rosenberger, PhD, is University Professor and Chairman of the Department of Statistics at George Mason University. He is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics, and author of over 80 refereed journal articles, as well as The Theory of Response-Adaptive Randomization in Clinical Trials, also published by Wiley. John M. Lachin, ScD, is Research Professor in the Department of Epidemiology and Biostatistics as well as in the Department of Statistics at The George Washington University. A Fellow of the American Statistical Association and the Society for Clinical Trials, Dr. Lachin is actively involved in coordinating center activities for clinical trials of diabetes. He is the author of Biostatistical Methods: The Assessment of Relative Risks, Second Edition, also published by Wiley.

Sharing Clinical Trial Data

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine

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.

Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide

Author : Agency for Health Care Research and Quality (U.S.)
Publisher : Government Printing Office
ISBN 13 : 1587634236
Total Pages : 236 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide by : Agency for Health Care Research and Quality (U.S.)

Download or read book Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide written by Agency for Health Care Research and Quality (U.S.) and published by Government Printing Office. This book was released on 2013-02-21 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)

Modern Approaches to Clinical Trials Using SAS

Author : Sandeep Menon
Publisher : SAS Institute
ISBN 13 : 1629600822
Total Pages : 482 pages
Book Rating : 4.6/5 (296 download)

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Book Synopsis Modern Approaches to Clinical Trials Using SAS by : Sandeep Menon

Download or read book Modern Approaches to Clinical Trials Using SAS written by Sandeep Menon and published by SAS Institute. This book was released on 2015-12-09 with total page 482 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Finding What Works in Health Care

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309164257
Total Pages : 267 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Finding What Works in Health Care by : Institute of Medicine

Download or read book Finding What Works in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.

Patient Treatment Adherence

Author : Hayden B. Bosworth
Publisher : Psychology Press
ISBN 13 : 1135616442
Total Pages : 588 pages
Book Rating : 4.1/5 (356 download)

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Book Synopsis Patient Treatment Adherence by : Hayden B. Bosworth

Download or read book Patient Treatment Adherence written by Hayden B. Bosworth and published by Psychology Press. This book was released on 2006-04-21 with total page 588 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new book summarizes the adherence literature for a number of specific health behaviors and populations. It provides a comprehensive source on the conceptualization, interventions, and measurement of treatment adherence and a synthesis of the research across demographic and chronic diseases. The text presents problems associated with treatment adherence; theoretical models that have commonly been used to understand, predict, and/or improve adherence; adherence with specific behaviors including exercise, diet, rehabilitation, medication, and psychological therapies; and strategies in enhancing adherence. Because chronic diseases involve similar behaviors, the handbook is organized by specific behaviors and special populations, and not by disease. Every chapter is sub-organized by specific diseases to ensure easy access for the readers and features a discussion of adherence across demographic and chronic conditions, a review of previous interventions directed at the particular behavior or population, questions and scoring algorithms for widely used measures of treatment adherence, a discussion of the clinical research, and where appropriate, policy implications. Patient Treatment Adherence addresses: practical recommendations to improve adherence; the impact of non-adherence including costs and health-related quality of life; methodological issues such as assessing cost-effectiveness; and the use of technological advances to improve adherence. Intended for health service professionals, health, clinical, social, and cognitive psychologists, primary care physicians, pharmacists, and policy-makers, this text is also an excellent resource for graduate courses on health psychology and public health.

Handbook of Corporate Finance

Author : Bjørn Espen Eckbo
Publisher : Elsevier
ISBN 13 : 0080488919
Total Pages : 559 pages
Book Rating : 4.0/5 (84 download)

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Book Synopsis Handbook of Corporate Finance by : Bjørn Espen Eckbo

Download or read book Handbook of Corporate Finance written by Bjørn Espen Eckbo and published by Elsevier. This book was released on 2007-05-21 with total page 559 pages. Available in PDF, EPUB and Kindle. Book excerpt: Judging by the sheer number of papers reviewed in this Handbook, the empirical analysis of firms' financing and investment decisions—empirical corporate finance—has become a dominant field in financial economics. The growing interest in everything "corporate is fueled by a healthy combination of fundamental theoretical developments and recent widespread access to large transactional data bases. A less scientific—but nevertheless important—source of inspiration is a growing awareness of the important social implications of corporate behavior and governance. This Handbook takes stock of the main empirical findings to date across an unprecedented spectrum of corporate finance issues, ranging from econometric methodology, to raising capital and capital structure choice, and to managerial incentives and corporate investment behavior. The surveys are written by leading empirical researchers that remain active in their respective areas of interest. With few exceptions, the writing style makes the chapters accessible to industry practitioners. For doctoral students and seasoned academics, the surveys offer dense roadmaps into the empirical research landscape and provide suggestions for future work.*The Handbooks in Finance series offers a broad group of outstanding volumes in various areas of finance*Each individual volume in the series should present an accurate self-contained survey of a sub-field of finance*The series is international in scope with contributions from field leaders the world over

Modelling Survival Data in Medical Research

Author : David Collett
Publisher :
ISBN 13 : 9780429258374
Total Pages : 368 pages
Book Rating : 4.2/5 (583 download)

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Book Synopsis Modelling Survival Data in Medical Research by : David Collett

Download or read book Modelling Survival Data in Medical Research written by David Collett and published by . This book was released on 1993 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data collected on the time to an event-such as the death of a patient in a medical study-is known as survival data. The methods for analyzing survival data can also be used to analyze data on the time to events such as the recurrence of a disease or relief from symptoms. Modelling Survival Data in Medical Research begins with an introduction to survival analysis and a description of four studies in which survival data was obtained. These and other data sets are then used to illustrate the techniques presented in the following chapters, including the Cox and Weibull proportional hazards models; accelerated failure time models; models with time-dependent variables; interval-censored survival data; model checking; and use of statistical packages. Designed for statisticians in the pharmaceutical industry and medical research institutes, and for numerate scientists and clinicians analyzing their own data sets, this book also meets the need for an intermediate text which emphasizes the application of the methodology to survival data arising from medical studies.

Model Rules of Professional Conduct

Author : American Bar Association. House of Delegates
Publisher : American Bar Association
ISBN 13 : 9781590318737
Total Pages : 216 pages
Book Rating : 4.3/5 (187 download)

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Book Synopsis Model Rules of Professional Conduct by : American Bar Association. House of Delegates

Download or read book Model Rules of Professional Conduct written by American Bar Association. House of Delegates and published by American Bar Association. This book was released on 2007 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.

Postgraduate Orthopaedics

Author : Paul A. Banaszkiewicz
Publisher : Cambridge University Press
ISBN 13 : 0521185106
Total Pages : 625 pages
Book Rating : 4.5/5 (211 download)

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Book Synopsis Postgraduate Orthopaedics by : Paul A. Banaszkiewicz

Download or read book Postgraduate Orthopaedics written by Paul A. Banaszkiewicz and published by Cambridge University Press. This book was released on 2012-01-19 with total page 625 pages. Available in PDF, EPUB and Kindle. Book excerpt: Extensively revised, updated and expanded, this new edition is the definitive guide to the FRCS (Tr and Orth) exam; essential reading for candidates.

Estimands, Estimators and Sensitivity Analysis in Clinical Trials

Author : Craig Mallinckrodt
Publisher : CRC Press
ISBN 13 : 0429950055
Total Pages : 208 pages
Book Rating : 4.4/5 (299 download)

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Book Synopsis Estimands, Estimators and Sensitivity Analysis in Clinical Trials by : Craig Mallinckrodt

Download or read book Estimands, Estimators and Sensitivity Analysis in Clinical Trials written by Craig Mallinckrodt and published by CRC Press. This book was released on 2019-12-23 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: The concepts of estimands, analyses (estimators), and sensitivity are interrelated. Therefore, great need exists for an integrated approach to these topics. This book acts as a practical guide to developing and implementing statistical analysis plans by explaining fundamental concepts using accessible language, providing technical details, real-world examples, and SAS and R code to implement analyses. The updated ICH guideline raises new analytic and cross-functional challenges for statisticians. Gaps between different communities have come to surface, such as between causal inference and clinical trialists, as well as among clinicians, statisticians, and regulators when it comes to communicating decision-making objectives, assumptions, and interpretations of evidence. This book lays out a path toward bridging some of these gaps. It offers  A common language and unifying framework along with the technical details and practical guidance to help statisticians meet the challenges  A thorough treatment of intercurrent events (ICEs), i.e., postrandomization events that confound interpretation of outcomes and five strategies for ICEs in ICH E9 (R1)  Details on how estimands, integrated into a principled study development process, lay a foundation for coherent specification of trial design, conduct, and analysis needed to overcome the issues caused by ICEs:  A perspective on the role of the intention-to-treat principle  Examples and case studies from various areas  Example code in SAS and R  A connection with causal inference  Implications and methods for analysis of longitudinal trials with missing data Together, the authors have offered the readers their ample expertise in clinical trial design and analysis, from an industrial and academic perspective.