Fundamentals of Clinical Trials

Written By Lawrence M. Friedman
Fundamentals of Clinical Trials
  • Publsiher : Unknown
  • Release : 30 August 2015
  • ISBN : 9783319307732
  • Pages : 550 pages
  • Rating : 4/5 from 21 reviews
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Read or download book entitled Fundamentals of Clinical Trials written by Lawrence M. Friedman which was release on 30 August 2015, this book published by Unknown. Available in PDF, EPUB and Kindle Format. Book excerpt: This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.Most chapters have been revised considerably from the fourth edition.A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added.There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and reporting the trial results according to the pre-specified objectives. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful.This book has been successfully used for teaching courses in clinical trial methodology. "

Fundamentals of Clinical Trials

Fundamentals of Clinical Trials
  • Author : Lawrence M. Friedman,Curt D. Furberg,David Demets,David M. Reboussin,Christopher B. Granger
  • Publisher : Unknown
  • Release Date : 2015-08-30
  • Total pages : 550
  • ISBN : 9783319307732
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Summary : This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.Most chapters ...

Clinical Trials

Clinical Trials
  • Author : Tom Brody
  • Publisher : Academic Press
  • Release Date : 2011-10-25
  • Total pages : 638
  • ISBN : 9783319307732
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Summary : Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive ...

Clinical Trials

Clinical Trials
  • Author : Stuart J. Pocock
  • Publisher : John Wiley & Sons
  • Release Date : 2013-07-17
  • Total pages : 288
  • ISBN : 9783319307732
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Summary : This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of clinical trials in a non-technical manner and provides a general perspective on their historical development, current status, and future strategy. ...

Design Execution and Management of Medical Device Clinical Trials

Design  Execution  and Management of Medical Device Clinical Trials
  • Author : Salah M. Abdel-aleem
  • Publisher : John Wiley & Sons
  • Release Date : 2009-09-08
  • Total pages : 296
  • ISBN : 9783319307732
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Summary : An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written ...

Global Clinical Trials

Global Clinical Trials
  • Author : Richard Chin,Menghis Bairu
  • Publisher : Academic Press
  • Release Date : 2011-05-06
  • Total pages : 522
  • ISBN : 9783319307732
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Summary : This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to ...

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
  • Release Date : 2011-09-09
  • Total pages : 268
  • ISBN : 9783319307732
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Summary : 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 ...

Clinical Trials Dictionary

Clinical Trials Dictionary
  • Author : Curtis L. Meinert
  • Publisher : John Wiley & Sons
  • Release Date : 2012-08-15
  • Total pages : 448
  • ISBN : 9783319307732
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Summary : A thoroughly updated new edition of the essential reference on the design, practice, and analysis of clinical trials Clinical Trials Dictionary: Terminology and Usage Recommendations, Second Edition presents clear, precise, meticulously detailed entries on all aspects of modern-day clinical trials. Written and compiled by one of the world’s leading ...

Business Administration for Clinical Trials Managing Research Strategy Finance Regulation and Quality

Business Administration for Clinical Trials  Managing Research  Strategy  Finance  Regulation  and Quality
  • Author : R. Jennifer Cavalieri,Mark E. Rupp
  • Publisher : Sigma Theta Tau
  • Release Date : 2014-11-19
  • Total pages : 370
  • ISBN : 9783319307732
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Summary : This guidebook provides research professionals with a deeper understanding of strategic planning, financial management, and regulatory implementation. This book demonstrates a strategy for managing your portfolio of clinical trials, provides tactics and real-world examples, and helps the reader adapt them to their own research site....

Clinical Trials with Missing Data

Clinical Trials with Missing Data
  • Author : Michael O'Kelly,Bohdana Ratitch
  • Publisher : John Wiley & Sons
  • Release Date : 2014-04-07
  • Total pages : 472
  • ISBN : 9783319307732
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Summary : This book provides practical guidance for statisticians, clinicians, and researchers involved in clinical trials in the biopharmaceutical industry, medical and public health organisations. Academics and students needing an introduction to handling missing data will also find this book invaluable. The authors describe how missing data can affect the outcome and ...

Clinical Trials

Clinical Trials
  • Author : Steven Piantadosi
  • Publisher : John Wiley & Sons
  • Release Date : 2017-08-28
  • Total pages : 920
  • ISBN : 9783319307732
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Summary : Presents elements of clinical trial methods that are essential in planning, designing, conducting, analyzing, and interpreting clinical trials with the goal of improving the evidence derived from these important studies This Third Edition builds on the text’s reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for ...

Design and Analysis of Clinical Trials

Design and Analysis of Clinical Trials
  • Author : Shein-Chung Chow,Jen-Pei Liu
  • Publisher : Wiley-Interscience
  • Release Date : 1998-06-23
  • Total pages : 649
  • ISBN : 9783319307732
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Summary : A unique, unifying treatment for statistics and science in clinical trials What sets this volume apart from the many books dealing with clinical trials is its integration of statistical and clinical disciplines. Stressing communication between biostatisticians and clinical scientists, this work clearly relates statistical interpretation to clinical issues arising in ...

Economic Evaluation in Clinical Trials

Economic Evaluation in Clinical Trials
  • Author : Henry A. Glick,Jalpa A. Doshi,Seema S. Sonnad
  • Publisher : Handbooks in Health Economic E
  • Release Date : 2014-10-02
  • Total pages : 272
  • ISBN : 9783319307732
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Summary : A a practical guide to the techniques and issues involved in conducting economic evaluation in ongoing clinical trials, supported with detailed advice on the design and analysis of studies including analysis of cost effectiveness and methodological integrity....

A Comprehensive and Practical Guide to Clinical Trials

A Comprehensive and Practical Guide to Clinical Trials
  • Author : Delva Shamley,Brenda Wright
  • Publisher : Academic Press
  • Release Date : 2017-06-07
  • Total pages : 210
  • ISBN : 9783319307732
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Summary : A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of ...

A Concise Guide to Clinical Trials

A Concise Guide to Clinical Trials
  • Author : J. Rick Turner
  • Publisher : Unknown
  • Release Date : 2011-09-01
  • Total pages : 114
  • ISBN : 9783319307732
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Summary : Biopharmaceutical drugs improve the health and well-being of people across the globe on a scale that is unrivaled by any other medical intervention. Before these drugs can be prescribed for patients by their doctors, they have to be approved for marketing by a regulatory agency. To gain marketing approval, drugs ...

Oncology Clinical Trials

Oncology Clinical Trials
  • Author : Susan Halabi, PhD,Wm. Kevin Kelly, DO
  • Publisher : Demos Medical Publishing
  • Release Date : 2009-12-22
  • Total pages : 168
  • ISBN : 9783319307732
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Summary : Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the ...