Guide To Clinical Trials

Author : JoAnn Pfeiffer,Cris Wells
Publisher : CRC Press
Page : 292 pages
File Size : 51,7 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.

Author : Bert Spilker
Publisher : Unknown
Page : 1156 pages
File Size : 43,7 Mb
Release : 1991
Category : Clinical Trials
ISBN : OCLC:23144415

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Guide to Clinical Trials by Bert Spilker Pdf

Author : Chris Sauber,Dan Sfera
Publisher : Independently Published
Page : 218 pages
File Size : 47,7 Mb
Release : 2019-04-21
Category : Electronic
ISBN : 1090349521

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The Comprehensive Guide To Clinical Research by Chris Sauber,Dan Sfera Pdf

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 : Allan Hackshaw
Publisher : John Wiley & Sons
Page : 184 pages
File Size : 42,6 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

Author : Duolao Wang,Ameet Bakhai
Publisher : Remedica
Page : 497 pages
File Size : 42,8 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.

Author : A. Cohen,J. Posner
Publisher : Springer Science & Business Media
Page : 232 pages
File Size : 49,5 Mb
Release : 2000-04-30
Category : Medical
ISBN : 0792361717

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A Guide to Clinical Drug Research by A. Cohen,J. Posner Pdf

Following the success of the first edition, published in 1995, this fully rewritten A Guide to Clinical Drug Research - Second Edition has been adapted to the most recent guidelines and developments in the field. It continues to provide a wealth of practical advice, ranging from the conception of an idea, planning a study and writing a protocol, through to the conduct of a study, data collection and analysis, and publication. It tells investigators what information they should expect sponsoring companies to provide, particularly when there is only limited information available about a new drug. It also explains what the company can expect of investigators, including the requirements of `good clinical practice'. Unlike other currently available texts on clinical trials and pharmaceutical medicine, A Guide to Clinical Drug Research concentrates on the needs of the practising clinician and research team. It is not restricted to drug investigation, and is relevant to all those involved in clinical research in a variety of settings. Audience: Required reading for clinical researchers and others involved as investigators in a drug project, often sponsored by a pharmacuetical company, plus agents of the sponsoring companies themselves.

Author : Jane Nikles,Geoffrey Mitchell
Publisher : Springer
Page : 245 pages
File Size : 41,8 Mb
Release : 2015-10-05
Category : Medical
ISBN : 9789401772006

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The Essential Guide to N-of-1 Trials in Health by Jane Nikles,Geoffrey Mitchell Pdf

N-of-1 trials, a type of individualized randomized controlled trial, are relevant to almost every discipline in medicine and psychology. They can tell the clinician with precision whether a treatment works in that individual, which distinguishes from the information available from most other trial designs. They have the potential to revolutionize the way clinical medicine is practiced. Whether you are a busy clinician, a researcher or a student, this book provides everything you need to know about N-of-1 trials. Written and edited by some of the world’s leading experts on N-of-1 trials, the book presents state of the art knowledge about N-of-1 trials, with chapters on ethics, statistics, health economics, design, analysis and reporting, and more. Full of examples and well illustrated, it is a comprehensive compendium of issues surrounding the design, conduct, interpretation and implementation of N-of-1 trials in a health system.

Author : Curtis L Meinert
Publisher : Oxford University Press
Page : 294 pages
File Size : 49,7 Mb
Release : 2011-05-18
Category : Medical
ISBN : 9780199876655

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An Insider's Guide to Clinical Trials by Curtis L Meinert Pdf

This book serves as an invaluable guide on how clinical trials are designed and run, how to interpret the results, and what to make of them in general. The book includes shopping guides for trials, a list of common abbreviations used by trialists, and tools for patients for deciding if or when to enroll in a clinical trial.

Author : Cemal Cingi,Nuray Bayar Muluk
Publisher : Springer
Page : 237 pages
File Size : 47,9 Mb
Release : 2016-11-15
Category : Medical
ISBN : 9783319443447

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Quick Guide to Good Clinical Practice by Cemal Cingi,Nuray Bayar Muluk Pdf

This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard – Good Clinical Practice – provided by the International Conference on Harmonization (ICH). The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols. Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applications to the ethic committees, whose approval is required for new clinical studies.

Author : J. Rick Turner
Publisher : Unknown
Page : 114 pages
File Size : 49,5 Mb
Release : 2011-09-01
Category : Clinical trials
ISBN : 0615507670

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A Concise Guide to Clinical Trials by J. Rick Turner Pdf

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 : Gerhard Fortwengel
Publisher : Karger Medical and Scientific Publishers
Page : 113 pages
File Size : 53,7 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.

Author : Sanjay Gupta
Publisher : Dna Press
Page : 1 pages
File Size : 43,6 Mb
Release : 2010
Category : Health & Fitness
ISBN : 9788190827713

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All You Need to Know about Clinical Research by Sanjay Gupta Pdf

This book is intended to provide a comprehensive understanding of the essential clinical trial elements in a concise fashion. It is intended to serve as a quick reference guide to all the personnel involved in the conduct of clinical trials as well as to those who plan to enter this field. Spanning over 167 pages the book provides a thorough compilation on, 1. Fundamentals of Clinical Research 2. Glossary of Clinical Trials Terminology (1052 frequently used terminologies of clinical research) 3. Abbreviations (224 frequently used terminologies of clinical research) 4. Clinical Trial Stakeholders 5. Clinical Study Process 6. Location of Essential Documents Before, During and After Completion of a Clinical Trial 7. Critical Milestones of a Clinical Trial Project 8. Overview of Regulatory Environment in USA, Australia, Europe, UK and India Being the first and only book on this important topic it has fulfilled the unmet need and is of great benefit to all the personnel involved in clinical research.

Author : Bert Spilker
Publisher : Unknown
Page : 1156 pages
File Size : 54,5 Mb
Release : 1996
Category : Drugs
ISBN : OCLC:37578757

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Guide to Clinical Trials by Bert Spilker Pdf

Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Page : 1247 pages
File Size : 53,8 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.

Author : M. U. R. Naidu,P. Usha Rani
Publisher : CRC Press
Page : 350 pages
File Size : 55,9 Mb
Release : 2013-01-29
Category : Medical
ISBN : 146659117X

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A Practical Guide to Human Research and Clinical Trials by M. U. R. Naidu,P. Usha Rani Pdf

Regulatory bodies such as the European Medicine Agency have done tremendous work in collaboration with experts from the field to develop Good Clinical Practices that apply not only in Europe but also in emerging countries. Designed to be a teaching aid and reference guide, A Practical Guide to Human Research and Clinical focuses on ethics, regulations, and guidelines. Conducting a successful clinical trial requires not only a strong basic knowledge, but also hands-on practical training. The book explains the intricate details of the subject to readers by citing concrete cases, exercises, and templates along with the theoretical aspects. Prof. M.U.R Naidu and his co-authors address all aspects of clinical trials from clinical research, drug development, and quality to methodology, biostatistics, and pharmacovigilance.