Design And Analysis Of Group Randomized Trials
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Design And Analysis Of Group Randomized Trials
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Author : David M. Murray
language : en
Publisher: Monographs in Epidemiology and
Release Date : 1998
Design And Analysis Of Group Randomized Trials written by David M. Murray and has been published by Monographs in Epidemiology and this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998 with Medical categories.
Community or group-randomized trials, which are usually done to evaluate the effect of health promotion effors. It reviews the underlying issues, describes the most widely used research design, and presents the many approaches to analysis that are now available.
Small Clinical Trials
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2001-02-01
Small Clinical Trials written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-02-01 with Medical categories.
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.
Cluster Randomised Trials
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Author : Richard J. Hayes
language : en
Publisher: CRC Press
Release Date : 2017-07-06
Cluster Randomised Trials written by Richard J. Hayes and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-07-06 with Mathematics categories.
Cluster Randomised Trials, Second Edition discusses the design, conduct, and analysis of trials that randomise groups of individuals to different treatments. It explores the advantages of cluster randomisation, with special attention given to evaluating the effects of interventions against infectious diseases. Avoiding unnecessary mathematical detail, the book covers basic concepts underlying the use of cluster randomisation, such as direct, indirect, and total effects. In the time since the publication of the first edition, the use of cluster randomised trials (CRTs) has increased substantially, which is reflected in the updates to this edition. There are greatly expanded sections on randomisation, sample size estimation, and alternative designs, including new material on stepped wedge designs. There is a new section on handling ordinal outcome data, and an appendix with descriptions and/or generating code of the example data sets. Although the book mainly focuses on medical and public health applications, it shows that the rigorous evidence of intervention effects provided by CRTs has the potential to inform public policy in a wide range of other areas. The book encourages readers to apply the methods to their own trials, reproduce the analyses presented, and explore alternative approaches.
Design And Analysis Of Pragmatic Trials
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Author : Song Zhang
language : en
Publisher: CRC Press
Release Date : 2023-05-16
Design And Analysis Of Pragmatic Trials written by Song Zhang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-05-16 with Mathematics categories.
This book begins with an introduction of pragmatic cluster randomized trials (PCTs) and reviews various pragmatic issues that need to be addressed by statisticians at the design stage. It discusses the advantages and disadvantages of each type of PCT, and provides sample size formulas, sensitivity analyses, and examples for sample size calculation. The generalized estimating equation (GEE) method will be employed to derive sample size formulas for various types of outcomes from the exponential family, including continuous, binary, and count variables. Experimental designs that have been frequently employed in PCTs will be discussed, including cluster randomized designs, matched-pair cluster randomized design, stratified cluster randomized design, stepped-wedge cluster randomized design, longitudinal cluster randomized design, and crossover cluster randomized design. It demonstrates that the GEE approach is flexible to accommodate pragmatic issues such as hierarchical correlation structures, different missing data patterns, randomly varying cluster sizes, etc. It has been reported that the GEE approach leads to under-estimated variance with limited numbers of clusters. The remedy for this limitation is investigated for the design of PCTs. This book can assist practitioners in the design of PCTs by providing a description of the advantages and disadvantages of various PCTs and sample size formulas that address various pragmatic issues, facilitating the proper implementation of PCTs to improve health care. It can also serve as a textbook for biostatistics students at the graduate level to enhance their knowledge or skill in clinical trial design. Key Features: Discuss the advantages and disadvantages of each type of PCTs, and provide sample size formulas, sensitivity analyses, and examples. Address an unmet need for guidance books on sample size calculations for PCTs; A wide variety of experimental designs adopted by PCTs are covered; The sample size solutions can be readily implemented due to the accommodation of common pragmatic issues encountered in real-world practice; Useful to both academic and industrial biostatisticians involved in clinical trial design; Can be used as a textbook for graduate students majoring in statistics and biostatistics.
Clinicaltrials
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Author : Curtis L. Meinert
language : en
Publisher: OUP USA
Release Date : 2012-03-27
Clinicaltrials written by Curtis L. Meinert and has been published by OUP USA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-03-27 with Medical categories.
The classic, definitive guide to the design, conduct, and analysis of randomized clinical trials.
Journal Of The National Cancer Institute
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Author :
language : en
Publisher:
Release Date : 2008
Journal Of The National Cancer Institute written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with Cancer categories.
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.
Successful Randomized Trials
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Author : Michael J. Domanski
language : en
Publisher: Lippincott Williams & Wilkins
Release Date : 2009
Successful Randomized Trials written by Michael J. Domanski and has been published by Lippincott Williams & Wilkins this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009 with Medical categories.
This handbook is a ready reference on the theory and operation of modern large, multicenter randomized clinical trials, which have come to be the basis of evidence-based medicine. Written in a concise, engaging style geared to physicians, the book explains the rationale and theoretical foundations for clinical trials, the components of modern clinical trials including their functions and interactions, and practical considerations in the design and implementation of these studies including an introduction to the economics and business aspects.
Principles And Practice Of Clinical Trials
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Author : Steven Piantadosi
language : en
Publisher: Springer Nature
Release Date : 2022-07-19
Principles And Practice Of Clinical Trials written by Steven Piantadosi and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-07-19 with Medical categories.
This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.
Pragmatic Randomized Clinical Trials
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Author : Cynthia J. Girman
language : en
Publisher: Academic Press
Release Date : 2021-04-08
Pragmatic Randomized Clinical Trials written by Cynthia J. Girman and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-04-08 with Science categories.
Pragmatic Randomized Clinical Trials Using Primary Data Collection and Electronic Health Records addresses the practical aspects and challenges of the design, implementation, and dissemination of pragmatic randomized trials, also sometimes referred to as practical or hybrid randomized trials. While less restrictive and more generalizable than traditional randomized controlled trials, such trials have specific challenges which are addressed in this book. The book contains chapters encompassing common designs along with advantages and limitations of such designs, analytic aspects in planning trials and estimating sample size, and how to use patient partners to help design and operationalize pragmatic randomized trials. Pragmatic trials conducted using primary data collection and trials embedded in electronic health records - including electronic medical records and administrative insurance claims - are addressed.This comprehensive resource is valuable not only for pharmacoepidemiologists, biostatisticians and clinical researchers, but also across the biomedical field for those who are interested in applying pragmatic randomized clinical trials in their research. - Addresses typical designs and challenges of pragmatic randomized clinical trials (pRCTs) - Encompasses analytic aspects of such trials - Discusses real cases on operational challenges in launching and conducting pRCTs in electronic health records