A Manager S Guide To The Design And Conduct Of Clinical Trials

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A Manager's Guide to the Design and Conduct of Clinical Trials

Phillip I. Good
A Manager s Guide to the Design and Conduct of Clinical Trials Book PDF

Author : Phillip I. Good
Publisher : John Wiley & Sons
Page : 272 pages
File Size : 40,6 Mb
Release : 2006-04-28
Category : Mathematics
ISBN : 9780471930877

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A Manager's Guide to the Design and Conduct of Clinical Trials by Phillip I. Good Pdf

This newly updated edition of the benchmark guide tocomputer-assisted clinical trials provides a comprehensive primerfor prospective managers. It covers every critical issue of thedesign and conduct of clinical trials, including study design,organization, regulatory agency liaison, data collection andanalysis, as well as recruitment, software, monitoring, andreporting. Keeping the same user-friendly format as the original, this SecondEdition features new examples and the latest developments inregulatory guidelines, such as e-submission procedures andcomputerized direct data acquisition. The new edition also reflectsthe increasing globalization of clinical trial activities, andincludes new information about international standards andprocedures, including the Common Technical Document and CDISCstandards. This step-by-step guide is supported by handy checklists andextracts from submitted protocols. Experienced author andconsultant Phillip Good incorporateshumorous yet instructiveanecdotes to illustrate common pitfalls. Based on the provenindustrial formula of planning, implementing, and finallyperforming essential checks, the book's three sections-"Plan,""Do," and "Check"-includethe following material: * Should the trials be conducted? * Put it in the computer and keep it there * Staffing for success * Designing trials and determining sample size * Budgeting * Recruiting and retaining patients and physicians * Data management * Monitoring the trials * Data analysis * After action review * Exception handling Executive and managerial professionals involved in the design andanalysis of clinical experiments, along with clinical researchassociates, biostatisticians, and students in public health willfind A Manager's Guide an indispensable resource. Praise for the First Edition: ". . . readable, informative and at times witty . . . never stopsbeing concise and well written . . . a book worth a read . .." -Statistics in Medicine "The book is very prescriptive and full of lists and tables withwhich to guide managers in making effective decisions in usingcomputer-assisted clinical trials in pharmaceutical studies."-Technometrics "This book is must-have reading for anyone in the business . .." -Clinical Chemistry

A Practical Guide to Managing Clinical Trials

JoAnn Pfeiffer,Cris Wells
A Practical Guide to Managing Clinical Trials Book PDF

Author : JoAnn Pfeiffer,Cris Wells
Publisher : CRC Press
Page : 292 pages
File Size : 52,6 Mb
Release : 2017-05-18
Category : Mathematics
ISBN : 9781315299778

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A Practical Guide to Managing Clinical Trials by JoAnn Pfeiffer,Cris Wells Pdf

A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.

Management of Data in Clinical Trials

Eleanor McFadden
Management of Data in Clinical Trials Book PDF

Author : Eleanor McFadden
Publisher : John Wiley & Sons
Page : 206 pages
File Size : 55,7 Mb
Release : 2007-12-14
Category : Mathematics
ISBN : 9780470181270

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Management of Data in Clinical Trials by Eleanor McFadden Pdf

A valuable new edition of the trusted, practical guide to managing data in clinical trials Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided. While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements. Newly featured topics include: The growing availability of "off-the-shelf" solutions for clinical trials Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry The increasing use of the Internet in the collection of data and management of trials Regulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) Guidelines Development of Standard Operating Procedures for the conduct of clinical trials Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels.

ClinicalTrials

Curtis L. Meinert
ClinicalTrials Book PDF

Author : Curtis L. Meinert
Publisher : OUP USA
Page : 702 pages
File Size : 40,8 Mb
Release : 2012-03-27
Category : Medical
ISBN : 9780195387889

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ClinicalTrials by Curtis L. Meinert Pdf

The classic, definitive guide to the design, conduct, and analysis of randomized clinical trials.

Clinical Trials Handbook

Shayne Cox Gad
Clinical Trials Handbook Book PDF

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 1247 pages
File Size : 53,5 Mb
Release : 2009-06-17
Category : Science
ISBN : 9780470466353

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Clinical Trials Handbook by Shayne Cox Gad Pdf

Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.

Clinical Trials

Duolao Wang,Ameet Bakhai
Clinical Trials Book PDF

Author : Duolao Wang,Ameet Bakhai
Publisher : Remedica
Page : 497 pages
File Size : 40,8 Mb
Release : 2006
Category : Medical
ISBN : 9781901346725

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Clinical Trials by Duolao Wang,Ameet Bakhai Pdf

This book explains statistics specifically for a medically literate audience. Readers gain not only an understanding of the basics of medical statistics, but also a critical insight into how to review and evaluate clinical trial evidence.

Global Clinical Trials

Richard Chin,Menghis Bairu
Global Clinical Trials Book PDF

Author : Richard Chin,Menghis Bairu
Publisher : Academic Press
Page : 522 pages
File Size : 54,7 Mb
Release : 2011-05-06
Category : Science
ISBN : 012381538X

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Global Clinical Trials by Richard Chin,Menghis Bairu Pdf

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 navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting Case studies outline successes, failures, lessons learned and prospects for future collaboration Includes country-specific guidelines for the most utilized countries Foreword by David Feigel, former Head of CDRH at FDA

The Fundamentals of Clinical Research

P. Michael Dubinsky,Karen A. Henry
The Fundamentals of Clinical Research Book PDF

Author : P. Michael Dubinsky,Karen A. Henry
Publisher : John Wiley & Sons
Page : 554 pages
File Size : 50,5 Mb
Release : 2022-01-26
Category : Medical
ISBN : 9781118949597

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The Fundamentals of Clinical Research by P. Michael Dubinsky,Karen A. Henry Pdf

This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources

A Comprehensive and Practical Guide to Clinical Trials

Delva Shamley,Brenda Wright
A Comprehensive and Practical Guide to Clinical Trials Book PDF

Author : Delva Shamley,Brenda Wright
Publisher : Academic Press
Page : 210 pages
File Size : 47,5 Mb
Release : 2017-06-07
Category : Medical
ISBN : 9780128047309

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A Comprehensive and Practical Guide to Clinical Trials by Delva Shamley,Brenda Wright Pdf

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 the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end. Describes the entire clinical trial management process from start to finish in a step-by-step guide Provides best practice elements, including case studies, practical examples, activities, and checklists Accompanied by a website with PowerPoint slides and an image bank

Randomized Clinical Trials

David Machin,Peter M. Fayers
Randomized Clinical Trials Book PDF

Author : David Machin,Peter M. Fayers
Publisher : John Wiley & Sons
Page : 375 pages
File Size : 46,6 Mb
Release : 2010-05-20
Category : Medical
ISBN : 9780470319222

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Randomized Clinical Trials by David Machin,Peter M. Fayers Pdf

Using examples and case studies from industry, academia and research literature, Randomized Clinical Trials provides a detailed overview of the key issues involved in designing, conducting, analysing and reporting randomized clinical trials. It examines the methodology for conducting Phase III clinical trials, developing the protocols, the practice for capturing, measuring, and analysing the resulting clinical data and their subsequent reporting. Randomized clinical trials are the principal method for determining the relative efficacy and safety of alternative treatments, interventions or medical devices. They are conducted by groups comprising one or more of pharmaceutical and allied health-care organisations, academic institutions, and charity supported research groups. In many cases such trials provide the key evidence necessary for the regulatory approval of a new product for future patient use. Randomized Clinical Trials provides comprehensive coverage of such trials, ranging from elementary to advanced level. Written by authors with considerable experience of clinical trials, Randomized Clinical Trials is an authoritative guide for clinicians, nurses, data managers and medical statisticians involved in clinical trials research and for health care professionals directly involved in patient care in a clinical trial context.

Clinical Trials Handbook

Curtis L. Meinert
Clinical Trials Handbook Book PDF

Author : Curtis L. Meinert
Publisher : John Wiley & Sons
Page : 469 pages
File Size : 45,9 Mb
Release : 2012-10-10
Category : Reference
ISBN : 9781118422793

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Clinical Trials Handbook by Curtis L. Meinert Pdf

A systematic approach to all aspects of designing and conducting clinical trials The success or failure of clinical trials hinges on hundreds of details that need to be developed, often under less than ideal conditions. Written by one of the world's leading trialists, Clinical Trials Handbook: Design and Conduct provides clinicians with a complete guide to designing, conducting, and evaluating clinical trials—teaching them how to simplify the process and avoid costly mistakes. The author draws on his extensive clinical trials experience to outline all steps employed in setting up and running clinical trials, from budgeting and fundraising to publishing the results. Along the way, practical advice is offered while also addressing a mix of logistical, ethical, psychological, behavioral, and administrative issues inherent to clinical trials. Topics of coverage include: Protocols for drug masking, controls, and treatment randomization Consent, enrollment, eligibility, and follow-up procedures Different types of sample size design and data collection and processing Working with study centers, research staff, and various committees Monitoring treatment effects and performance, and ensuring quality control Data analysis and access policies for study data and documents Clinical Trials Handbook is invaluable for practicing clinicians and trialists who would like to learn more about or improve their understanding of the design and execution of clinical trials. The book is also an excellent supplement for courses on clinical trials at the graduate level.

Clinical Trials

Stuart J. Pocock
Clinical Trials Book PDF

Author : Stuart J. Pocock
Publisher : John Wiley & Sons
Page : 288 pages
File Size : 54,6 Mb
Release : 2013-07-17
Category : Medical
ISBN : 9781118793923

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Clinical Trials by Stuart J. Pocock Pdf

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. Features examples derived from the author's personal experience.

A Concise Guide to Clinical Trials

Allan Hackshaw
A Concise Guide to Clinical Trials Book PDF

Author : Allan Hackshaw
Publisher : John Wiley & Sons
Page : 184 pages
File Size : 47,9 Mb
Release : 2011-09-07
Category : Medical
ISBN : 9781444356663

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A Concise Guide to Clinical Trials by Allan Hackshaw Pdf

Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgical techniques, and changes in behaviour and lifestyle. A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews, health-related quality of life and health economic evaluation. The book also covers the ethical and legal requirements in setting up a clinical trial due to an increase in governance responsibilities and regulations. This practical guidebook is ideal for busy clinicians and other health professionals who do not have enough time to attend courses or search through extensive textbooks. It will help anyone involved in undertaking clinical research, or those reading about trials. The book is aimed at: Those wishing to learn about clinical trials for the first time, or as a quick reference guide, for example as part of a taught course on clinical trials Health professionals who wish to conduct their own trials, or participate in other people’s studies People who work in pharmaceutical companies, grant funding organisations, or regulatory agencies

Randomised Clinical Trials

David Machin,Peter M. Fayers,Bee Choo Tai
Randomised Clinical Trials Book PDF

Author : David Machin,Peter M. Fayers,Bee Choo Tai
Publisher : John Wiley & Sons
Page : 86 pages
File Size : 47,8 Mb
Release : 2021-07-26
Category : Medical
ISBN : 9781119524649

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Randomised Clinical Trials by David Machin,Peter M. Fayers,Bee Choo Tai Pdf

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.

Guide for Clinical Trial Staff

Gerhard Fortwengel
Guide for Clinical Trial Staff Book PDF

Author : Gerhard Fortwengel
Publisher : Karger Medical and Scientific Publishers
Page : 113 pages
File Size : 42,7 Mb
Release : 2004
Category : Medical
ISBN : 9783805576550

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Guide for Clinical Trial Staff by Gerhard Fortwengel Pdf

The standard to which clinical trials must conform is called 'Good Clinical Practice' (GCP). GCP is defined as a standard that ensures adequate protection of subjects participating in clinical trials; furthermore, it ensures that all trial activities and data are meticulously documented and reported. The latest GCP guideline was developed by the International Conference on Harmonization (ICH) and was first published in May 1996. This guideline is based on ethical principles that have their origin in the Declaration of Helsinki (1964, last modified in October 2000). Besides GCP, clinical trials must also comply with the local law of the country where the study is being conducted. This book will be an indispensable companion for those conducting clinical trials and should have a fixed place in the library of every investigator and his staff.