A Concise Guide To Clinical Trials

Author : Allan Hackshaw
Publisher : John Wiley & Sons
ISBN 13 : 1444356666
Total Pages : 184 pages
Book Rating : 4.63/5 ( download)

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Download or read book A Concise Guide to Clinical Trials written by Allan Hackshaw and published by John Wiley & Sons. This book was released on 2011-09-07 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Author : J. Rick Turner
Publisher :
ISBN 13 : 9780615507675
Total Pages : 114 pages
Book Rating : 4.70/5 ( download)

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Download or read book A Concise Guide to Clinical Trials written by J. Rick Turner and published by . This book was released on 2011-09-01 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 must go through an extremely rigorous process that investigates their safety and efficacy, the process of New Drug Development. The last stage of this long, complex, and expensive process involves conducting clinical trials, the topic of this book. Successfully conducting clinical trials requires the interdisciplinary collaboration of individuals from many clinical and scientific disciplines and areas of operational expertise. These include medicine, information technology, ethics and law, statistics, clinical trial operations, data collection and management, regulatory science, and medical writing, to name just a few. Central aspects of conducting clinical trials are discussed in the following chapters, with the goals of making specialists from each of these areas aware of the contributions of their colleagues, and helping readers to appreciate that everyone involved in clinical research is working side-by-side toward a common goal---improving the health, well-being, and longevity of millions of patients around the globe.

Author : JoAnn Pfeiffer
Publisher : CRC Press
ISBN 13 : 1315299771
Total Pages : 292 pages
Book Rating : 4.78/5 ( download)

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Download or read book A Practical Guide to Managing Clinical Trials written by JoAnn Pfeiffer and published by CRC Press. This book was released on 2017-05-18 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Chris Sauber
Publisher : Independently Published
ISBN 13 : 9781090349521
Total Pages : 218 pages
Book Rating : 4.21/5 ( download)

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Download or read book The Comprehensive Guide To Clinical Research written by Chris Sauber and published by Independently Published. This book was released on 2019-04-21 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: Condensing the most important topics in all of clinical research in an easy to understand presentation. The 20 percent of what you need to know in order to be 80 percent proficient!The authors who have operated various levels of businesses in the clinical research industry since 2005 believe that more practical information pertaining to clinical research needs to be accessible to individuals who are new to the industry or are curious about entering the rewarding world of clinical trials.This book reads in an easy to understand style and is based on proven methods the authors have developed to train their own employees and students of their various clinical research academies throughout the years. Picking this up and absorbing the information will allow anyone to gain much better insight into the complicated dynamics of clinical research. This practical roadmap is all you will need to get started on your clinical trial journey!In this book you will learn about:Regulations and the history as well as evolution of GCP.Clinical Research Site OperationsMonitoring Dynamics and Typical Monitoring VistsCRO ActivitiesSponsor Level DynamicsIndustry VendorsCommon Career Opportunities and Employment Roadmaps

Author : Margaret Liu
Publisher : John Wiley & Sons
ISBN 13 : 1444357883
Total Pages : 381 pages
Book Rating : 4.82/5 ( download)

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Download or read book A Clinical Trials Manual From The Duke Clinical Research Institute written by Margaret Liu and published by John Wiley & Sons. This book was released on 2011-08-24 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity." —Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical "nuts and bolts" approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.

Author : Duolao Wang
Publisher : Remedica
ISBN 13 : 1901346722
Total Pages : 497 pages
Book Rating : 4.25/5 ( download)

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Download or read book Clinical Trials written by Duolao Wang and published by Remedica. This book was released on 2006 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Gregory E. Gray
Publisher : American Psychiatric Pub
ISBN 13 : 1585626961
Total Pages : 268 pages
Book Rating : 4.60/5 ( download)

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Download or read book Concise Guide to Evidence-Based Psychiatry written by Gregory E. Gray and published by American Psychiatric Pub. This book was released on 2008-05-20 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Concise Guide to Evidence-Based Psychiatry (EBP) is a must-have resource for informed decision-making in psychiatric practice today. This single, easy-to-use reference will enable practitioners to find answers to clinical questions, critically appraise articles, and apply the results of their findings to patients. This practical handbook provides quick access to EBP theories, tools, and methods. Concise Guide to Evidence-Based Psychiatry is a one-stop reference for using the literature to improve patient outcomes. Features include: Practical -- Filled with how-to information, Concise Guide to Evidence-Based Psychiatry outlines the latest techniques for accessing, assessing, and interpreting the literature. Easy to use -- Includes many tables of essential websites for finding reliable information on the Internet, best-practice strategies for searching the medical literature. Concise Guide to Evidence-Based Psychiatry fills an important role as the first EBP text for teaching residents, who are now required to develop such skills to meet the ACGME "practice-based learning and improvement" core competency. Special features for pedagogical use include suggestions for teaching EBP in residency programs, profuse examples from the psychiatric literature, and worksheets for the critical appraisal of clinical trials, diagnostic tests, epidemiologic studies, studies of prognosis, and more. Whether for self-study or use in residency programs, Concise Guide to Evidence-Based Psychiatry is the best resource available to help practitioners apply current research findings to their work with patients.

Author : Mohit Bhandari
Publisher : Thieme
ISBN 13 : 3131494514
Total Pages : 334 pages
Book Rating : 4.11/5 ( download)

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Download or read book Clinical Research for Surgeons written by Mohit Bhandari and published by Thieme. This book was released on 2011-01-01 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for this book:Readable, relevant, and interesting...this book cuts through jargon, recapitulates key concepts, and clarifies with current examples from the literature...recommend[ed].--Doody's ReviewClinical Research for Surgeons is a practical guide for understanding, planning, conducting, and evaluating surgical research. It covers the principles of evidence-based surgery and applies these principles to the design of suitable research studies. The reader will come to fully understand important concepts such as case-control study, prospective cohort study, randomized trial, and reliability study. The book provides valuable discussions of the critical appraisal of published clinical studies, allowing the reader to learn how to evaluate the quality of such studies with respect to measuring outcomes and to make effective use of all types of evidence in patient care.Highlights: Insights from experienced surgeons and veteran researchers Easy-to-reference text boxes with Key Concepts, Jargon Simplified, and Examples from the Literature Coverage of both open and minimally-invasive surgical procedures 50 illustrations demonstrating key points This book is a valuable reference for clinicians and residents in a range of disciplines, including general surgery, orthopedic surgery, plastic and reconstructive surgery, urology, neurosurgery, otolaryngology-head and neck surgery, interventional radiology, cardiac surgery.

Author : Allan Hackshaw
Publisher : John Wiley & Sons
ISBN 13 : 0470658673
Total Pages : 250 pages
Book Rating : 4.73/5 ( download)

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Download or read book A Concise Guide to Observational Studies in Healthcare written by Allan Hackshaw and published by John Wiley & Sons. This book was released on 2015-03-02 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Concise Guide to Observational Studies in Healthcare provides busy healthcare professionals with an easy-to-read introduction and overview to conducting, analysing and assessing observational studies. It is a suitable introduction for anyone without prior knowledge of study design, analysis or conduct as the important concepts are presented throughout the text. It provides an overview to the features of design, analyses and conduct of observational studies, without using mathematical formulae, or complex statistics or terminology and is a useful guide for researchers conducting their own studies, those who participate in studies co-ordinated by others, or who read or review a published report of an observational study. Examples are based on clinical features of people, biomarkers, lifestyle habits and environmental exposures, and evaluating quality of care.

Author : Tomasz M. Beer
Publisher : Diamedica
ISBN 13 : 9780982321973
Total Pages : 0 pages
Book Rating : 4.7X/5 ( download)

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Download or read book Cancer Clinical Trials written by Tomasz M. Beer and published by Diamedica. This book was released on 2012 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: A readable guide for anyone who is considering therapeutic options in addition to standard cancer therapy. The book seeks to share knowledge about cancer clinical trials with people living with cancer, their families and loved ones.