Fundamental Concepts For New Clinical Trialists

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Fundamental Concepts For New Clinical Trialists


Fundamental Concepts For New Clinical Trialists
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Fundamental Concepts For New Clinical Trialists


Fundamental Concepts For New Clinical Trialists
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Author : SCOTT. TING EVANS (NAITEE.)
language : en
Publisher: CRC Press
Release Date : 2021-03-31

Fundamental Concepts For New Clinical Trialists written by SCOTT. TING EVANS (NAITEE.) and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-03-31 with categories.


This text describes the core scientific concepts of designing, data monitoring, analyzing, and reporting clinical trials as well as the practical aspects of trials not typically discussed in statistical methodology textbooks. It offers first-hand perspectives on real-world issues, such as common and challenging clinical trial designs and the pro

Fundamental Concepts For New Clinical Trialists


Fundamental Concepts For New Clinical Trialists
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Author : Scott Evans
language : en
Publisher: CRC Press
Release Date : 2015-11-04

Fundamental Concepts For New Clinical Trialists written by Scott Evans and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-11-04 with Mathematics categories.


Fundamental Concepts for New Clinical Trialists describes the core scientific concepts of designing, data monitoring, analyzing, and reporting clinical trials as well as the practical aspects of trials not typically discussed in statistical methodology textbooks. The first section of the book provides background information about clinical trials. It defines and compares clinical trials to other types of research studies and discusses clinical trial phases, registration, the protocol document, ethical issues, product development, and regulatory processes. It also includes a special chapter outlining the valuable attributes that statisticians can develop to maximize their contributions to a clinical trial. The second section examines scientific issues faced in each progressive step of a clinical trial. It covers issues in trial design, such as randomization, blinding, control-group selection, endpoint selection, superiority versus noninferiority, and parallel group versus crossover designs; data monitoring; analyses of efficacy, safety, and benefit-risk; and the reporting/publication of clinical trial results. As clinical trials remain the gold standard research studies for evaluating the effects of a medical intervention, newcomers to the field must have a fundamental understanding of the concepts to tackle real-world issues in all stages of trials. Drawing on their experiences in academia and industry, the authors provide a foundation for understanding the fundamental concepts necessary for working in clinical trials.

Multiregional Clinical Trials For Simultaneous Global New Drug Development


Multiregional Clinical Trials For Simultaneous Global New Drug Development
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Author : Joshua Chen
language : en
Publisher: CRC Press
Release Date : 2016-04-21

Multiregional Clinical Trials For Simultaneous Global New Drug Development written by Joshua Chen and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-21 with Mathematics categories.


In a global clinical development strategy, multiregional clinical trials (MRCTs) are vital in the development of innovative medicines. Multiregional Clinical Trials for Simultaneous Global New Drug Development presents a comprehensive overview on the current status of conducting MRCTs in clinical development. International experts from academia, in

Bayesian Designs For Phase I Ii Clinical Trials


Bayesian Designs For Phase I Ii Clinical Trials
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Author : Ying Yuan
language : en
Publisher: CRC Press
Release Date : 2017-12-19

Bayesian Designs For Phase I Ii Clinical Trials written by Ying Yuan and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-12-19 with Mathematics categories.


Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. Bayesian Designs for Phase I–II Clinical Trials describes how phase I–II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. It emphasizes the importance of basing decisions on both efficacy and toxicity.

Group Sequential Clinical Trials With Multiple Co Objectives


Group Sequential Clinical Trials With Multiple Co Objectives
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Author : Toshimitsu Hamasaki
language : en
Publisher: Springer
Release Date : 2016-06-01

Group Sequential Clinical Trials With Multiple Co Objectives written by Toshimitsu Hamasaki and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-06-01 with Mathematics categories.


This book focuses on group sequential methods for clinical trials with co-primary endpoints based on the decision-making frameworks for: (1) rejecting the null hypothesis (stopping for efficacy), (2) rejecting the alternative hypothesis (stopping for futility), and (3) rejecting the null or alternative hypothesis (stopping for either futility or efficacy), where the trial is designed to evaluate whether the intervention is superior to the control on all endpoints. For assessing futility, there are two fundamental approaches, i.e., the decision to stop for futility based on the conditional probability of rejecting the null hypothesis, and the other based on stopping boundaries using group sequential methods. In this book, the latter approach is discussed. The book also briefly deals with the group sequential methods for clinical trials designed to evaluate whether the intervention is superior to the control on at least one endpoint. In addition, the book describes sample size recalculation and the resulting effect on power and type I error rate. The book also describes group sequential strategies for three-arm clinical trials to demonstrate the non-inferiority of experimental intervention to actively control and to assess the assay sensitivity to placebo control.

Design Analysis Of Clinical Trials For Economic Evaluation Reimbursement


Design Analysis Of Clinical Trials For Economic Evaluation Reimbursement
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Author : Iftekhar Khan
language : en
Publisher: CRC Press
Release Date : 2015-11-11

Design Analysis Of Clinical Trials For Economic Evaluation Reimbursement written by Iftekhar Khan and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-11-11 with Mathematics categories.


Economic evaluation has become an essential component of clinical trial design to show that new treatments and technologies offer value to payers in various healthcare systems. Although many books exist that address the theoretical or practical aspects of cost-effectiveness analysis, this book differentiates itself from the competition by detailing

Repeated Measures Design With Generalized Linear Mixed Models For Randomized Controlled Trials


Repeated Measures Design With Generalized Linear Mixed Models For Randomized Controlled Trials
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Author : Toshiro Tango
language : en
Publisher: CRC Press
Release Date : 2017-09-14

Repeated Measures Design With Generalized Linear Mixed Models For Randomized Controlled Trials written by Toshiro Tango and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-14 with Mathematics categories.


Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials is the first book focused on the application of generalized linear mixed models and its related models in the statistical design and analysis of repeated measures from randomized controlled trials. The author introduces a new repeated measures design called S:T design combined with mixed models as a practical and useful framework of parallel group RCT design because of easy handling of missing data and sample size reduction. The book emphasizes practical, rather than theoretical, aspects of statistical analyses and the interpretation of results. It includes chapters in which the author describes some old-fashioned analysis designs that have been in the literature and compares the results with those obtained from the corresponding mixed models. The book will be of interest to biostatisticians, researchers, and graduate students in the medical and health sciences who are involved in clinical trials. Author Website: Data sets and programs used in the book are available at http://www.medstat.jp/downloadrepeatedcrc.html