The Design of Studies for Medical Research

The Design of Studies for Medical Research

Author: David Machin

Publisher: John Wiley & Sons

ISBN: 9780470012987

Category: Medical

Page: 286

View: 330

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The same careful rigour imposed on the design of phase III randomised controlled trials is not always applied to medical research in other areas such as trials conducted at earlier stages of drug development. With the emphasis that is now placed on evidence-based medicine, such care and rigour will inevitably impact on these areas with increasing attention turned to the quality of design. This title describes what principles can be used to structure research effectively allowing for the required degree of accuracy. Written by two best selling authors, this book includes many examples from medical literature and will be of great value to all groups conducting studies at the interface of clinical and laboratory research.

The Design of Studies for Medical Research

The Design of Studies for Medical Research

Author: David Machin

Publisher: Wiley

ISBN: 9780470012987

Category: Medical

Page: 286

View: 250

Get eBOOK →
The same careful rigour imposed on the design of phase III randomised controlled trials is not always applied to medical research in other areas such as trials conducted at earlier stages of drug development. With the emphasis that is now placed on evidence-based medicine, such care and rigour will inevitably impact on these areas with increasing attention turned to the quality of design. This title describes what principles can be used to structure research effectively allowing for the required degree of accuracy. Written by two best selling authors, this book includes many examples from medical literature and will be of great value to all groups conducting studies at the interface of clinical and laboratory research.

Design and Analysis of Clinical Trials

Design and Analysis of Clinical Trials

Author: Shein-Chung Chow

Publisher: John Wiley & Sons

ISBN: 0470887656

Category: Mathematics

Page: 0

View: 842

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Praise for the Second Edition: “...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.” —Journal of Clinical Research Best Practices The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides a well-balanced summary of current regulatory requirements and recently developed statistical methods as well as an overview of the various designs and analyses that are utilized at different stages of clinical research and development. Additional features of this Third Edition include: • New chapters on biomarker development and target clinical trials, adaptive design, trials for evaluating diagnostic devices, statistical methods for translational medicine, and traditional Chinese medicine • A balanced overview of current and emerging clinical issues as well as newly developed statistical methodologies • Practical examples of clinical trials that demonstrate everyday applicability, with illustrations and examples to explain key concepts • New sections on bridging studies and global trials, QT studies, multinational trials, comparative effectiveness trials, and the analysis of QT/QTc prolongation • A complete and balanced presentation of clinical and scientific issues, statistical concepts, and methodologies for bridging clinical and statistical disciplines • An update of each chapter that reflects changes in regulatory requirements for the drug review and approval process and recent developments in statistical design and methodology for clinical research and development Design and Analysis of Clinical Trials, Third Edition continues to be an ideal clinical research reference for academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students.

Randomised Clinical Trials

Randomised Clinical Trials

Author: David Machin

Publisher: John Wiley & Sons

ISBN: 9781119524649

Category: Medical

Page: 86

View: 542

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Randomised Clinical Trials: Design, Practice and Reporting provides a detailed overview of the methodology for conducting clinical trials, including developing protocols, data capture, randomisation, analysis and reporting. Assuming no prior background, this user-friendly resource describes the statistical, regulatory, and practical components required for conducting randomised clinical trials. Numerous examples and case studies from industry, academia, and the research literature help readers understand each stage of the clinical trial process. This second edition contains extensively revised material throughout, including new chapters covering designs for repeated measures, non-inferiority, cluster and stepped wedge trials. Other new chapters describe data and safety monitoring, biomarker studies, and feasibility studies. Updated and expanded sections discuss situations where multiple organs, different body locations or competing risks are involved, subgroup analysis, and multiple outcomes. Written by an author team with extensive experience in conducting clinical trials, this book: Provides comprehensive coverage of randomised clinical trials, ranging from basic to advanced Features several new chapters, updated case studies and examples, and references to changes in regulations Explains basic randomised trials, including the parallel two-group controlled trial with a single outcome measure Covers paired trial designs and trials with more than two interventions Includes a chapter on miscellaneous topics such as adaptive designs, large simple trials, Bayesian methods for very small trials, alpha-spending functions and the predictive probability test Randomised Clinical Trials is essential reading for clinicians, nurses, data managers, and medical statisticians involved in clinical trials, and for health practitioners responsible for direct patient care in a clinical trial setting.

Understanding Clinical Research

Understanding Clinical Research

Author: Renato D. Lopes

Publisher: McGraw Hill Professional

ISBN: 9780071792653

Category: Medical

Page: 272

View: 539

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A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples--drawn from the authors' broad experience--that put chapter concepts into action and contribute to a working knowledge of integral research techniques. FEATURES: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials

New Drug Development

New Drug Development

Author: J. Rick Turner

Publisher: John Wiley & Sons

ISBN: 9780470073735

Category: Mathematics

Page: 298

View: 852

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This book acquaints students and practitioners in the related fields of pharmaceutical sciences, clinical trials, and evidence-based medicine with the necessary study design concepts and statistical practices to allow them to understand how drug developers plan and evaluate their drug development. Two goals of the book are to make the material accessible to readers with minimal background in research and to be straightforward enough for self-taught purposes. By bringing the topic from the early discovery phase to clinical trials and medical practice, the book provides an indispensable overview of an otherwise confusing and fragmented set of topics. The author’s experience as a respected scientist, teacher of statistics, and one who has worked in the clinical trials arena makes him well suited to write such a treatise.

Designs for Clinical Trials

Designs for Clinical Trials

Author: David Harrington

Publisher: Springer

ISBN: 1461429536

Category: Medical

Page: 206

View: 797

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This book will examine current issues and controversies in the design of clinical trials, including topics in adaptive and sequential designs, the design of correlative genomic studies, the design of studies in which missing data is anticipated. Each chapter will be written by an expert conducting research in the topic of that chapter. As a collection, the chapters would be intended to serve as a guidance for statisticians designing trials.

Human Experimentation

Human Experimentation

Author: Ton J. Cleophas

Publisher: Springer Science & Business Media

ISBN: 0792358279

Category: Mathematics

Page: 124

View: 335

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Despite their effectiveness in the evaluation of new pharmacological compounds, controlled clinical trials are sometimes inadequate. Using data from the literature as well as from the author's own experience with clinical trials, Human Experimentation: Methodologic Issues Fundamental to Clinical Trials addresses such inadequacies and tries to provide solutions. This work is the first to thoroughly examine these unsolved inadequacies and problems with the design and the execution of clinical trials and, more importantly, to provide solutions for these problems. It is important for anyone who is involved in clinical research: clinicians, pharmacists, biochemists, statisticians, nurses, sponsors, etc., and anyone who is involved in applying results of research to patients, i.e. physicians.

The Design and Management of Medical Device Clinical Trials

The Design and Management of Medical Device Clinical Trials

Author: Salah M. Abdel-aleem

Publisher: John Wiley & Sons

ISBN: 9781118164624

Category: Medical

Page: 268

View: 847

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Clinical trials tasks and activities are widely diverse and require certain skill sets to both plan and execute. This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It discusses key obstacles such as challenges to patient recruitment, investigator and study site selection, and dealing with compliance issues. Through practical examples, professionals working with medical device clinical trials will discover the appropriate steps to take.

Handbook for Health Care Research

Handbook for Health Care Research

Author: Robert Chatburn

Publisher: Jones & Bartlett Learning

ISBN: 9780763778057

Category: Medical

Page: 394

View: 310

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"Handbook for Health Care Research, Second Edition, provides step-by-step guidelines for conducting and analyzing research, teaching students and practitioners how to implement research protocols and evaluate the results even if they lack experience or formal training in the research process. Features include easy reference of basic research procedures and definitions as well as information on how to determine the proper test to use and how to format information for computer entry. Statistical procedures and published findings are illustrated with real-world examples from health care practice in this user-friendly resource. Readers will also learn the research basics necessary to understand scientific articles in medical journals and discover how to write abstracts that will pass peer review. Handbook for Health Care Research, Second Edition, is an excellent tool to help students and practitioners become "educated consumers" of research and apply the principles of scientific analysis to provide a sound basis for patient care." --Book Jacket.