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A Concise Guide To Clinical Trials
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Book Synopsis A Concise Guide to Clinical Trials by : Allan Hackshaw
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
Book Synopsis A Concise Guide to Clinical Trials by : J. Rick Turner
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.
Book Synopsis A Practical Guide to Managing Clinical Trials by : JoAnn Pfeiffer
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.
Book Synopsis The Comprehensive Guide To Clinical Research by : Chris Sauber
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
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.
Book Synopsis Designing Clinical Research by : Stephen B. Hulley
Download or read book Designing Clinical Research written by Stephen B. Hulley and published by Lippincott Williams & Wilkins. This book was released on 2011-11-30 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.
Book Synopsis A Clinical Trials Manual From The Duke Clinical Research Institute by : Margaret Liu
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.
Download or read book Clinical Trials written by Tom Brody and published by Academic Press. This book was released on 2016-02-19 with total page 897 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers
Book Synopsis Presenting Your Case by : Clifford D. Packer
Download or read book Presenting Your Case written by Clifford D. Packer and published by Springer. This book was released on 2019-04-29 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical students often struggle when presenting new patients to the attending physicians on the ward. Case presentation is either poorly taught or not taught at all in the first two years of medical school. As a result, students are thrust into the spotlight with only sketchy ideas about how to present, prioritize, edit, and focus their case presentations. They also struggle with producing a broad differential diagnosis and defending their leading diagnosis. This text provides a comprehensive guide to give well-prepared, focused and concise presentations. It also allows students to discuss differential diagnosis, incorporate high-value care, educate their colleagues, and participate actively in the care of their patients. Linking in-depth discussion of the oral presentation with differential diagnosis and high value care, Presenting Your Case is a valuable resource for medical students, clerkship directors and others who educate students on the wards and in the clinic.
Book Synopsis Cancer Clinical Trials by : Tomasz M. Beer
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.
Book Synopsis Concise Guide to Hematology by : Hillard M. Lazarus
Download or read book Concise Guide to Hematology written by Hillard M. Lazarus and published by Springer. This book was released on 2018-11-15 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt: This text provides a comprehensive overview of the essential concepts and malignancies of hematology. Now in its second edition, the book reviews every major hematologic disorder and disease entity in thorough detail, from incidence and prevalence to patient and treatment-related issues. Formatted in an organized and easy-to-read outline style to facilitate rapid learning and information processing, the book allows readers to easily locate topics of immediate interest without wading through entire sections to obtain the desired data. Written by a diverse range of experts in the field, Concise Guide to Hematology, Second Edition is a valuable resource for clinicians, residents, trainees, and entry-level fellows who work in or are just entering the field of hematology.
Book Synopsis Clinical Research for Surgeons by : Mohit Bhandari
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.
Book Synopsis A Concise Guide to Endodontic Procedures by : Peter Murray
Download or read book A Concise Guide to Endodontic Procedures written by Peter Murray and published by Springer. This book was released on 2014-10-07 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt: This clinical guide is a concise up-to-date resource that covers a wide range of endodontic procedures, including non-surgical root canal therapy, surgical root canal therapy, trauma care and the management of fractured teeth, apexification, apexogenesis, revascularization, regeneration, Cvek partial pulpotomy, root canal retreatment, and periapical surgery. The provision of numerous flowcharts, checklists, and advice on error avoidance for each procedure will assist in decision-making in daily practice. Scientific and clinical evidence regarding the use and efficacy of the different forms of treatment is summarized, and helpful information is also presented on instrumentation. The inclusion of exam questions will assist those preparing for endodontic examinations. A Primer on Endodontic Treatment will be of value for dental students, residents in training to become endodontists, endodontists, pediatric dentists, and established dentists.
Book Synopsis The CRA's Guide to Monitoring Clinical Research by : Karen E. Woodin
Download or read book The CRA's Guide to Monitoring Clinical Research written by Karen E. Woodin and published by CenterWatch. This book was released on 2003-01-01 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Clinical Trials in Ophthalmology by : Peter J. Kertes
Download or read book Clinical Trials in Ophthalmology written by Peter J. Kertes and published by Lippincott Williams & Wilkins. This book was released on 1998 with total page 470 pages. Available in PDF, EPUB and Kindle. Book excerpt: Each chapter in this unique resource summarizes the important findings and recommendations of a major clinical trial. Readers will find the rationale for the study and a description of its primary and secondary outcomes. The patient population is described along with the different arms of treatment undertaken. Treatments are discussed, with tables that summarize how patients meeting various criteria should be treated.
Book Synopsis Business Administration for Clinical Trials by : Ruth Jennifer Cavalieri
Download or read book Business Administration for Clinical Trials written by Ruth Jennifer Cavalieri and published by . This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical research administration is much like an orange-remove the peel, and what appears to be simple is actually many interconnected, but separate, sections. Investigators conducting clinical research trials must manage the myriad administrative aspects of the research enterprise. New investigators often underestimate the time commitment and resources that research management requires. Clinical research professionals must manage this complicated process while fostering productive environments and relationships and also navigating regulation, compliance, and the institutional review board. Filled with tools, techniques, and templates, Business Administration for Clinical Trials provides research professionals a road map and deeper understanding of strategic planning, financial management, and regulatory implementation to successfully conduct clinical research trials. Cavalieri and Rupp share their highly practical and easily adaptable tactics for developing an effective administrative infrastructure and designing a study down to the granular level. This book will help you: - Develop business plans - Negotiate study contracts - Navigate regulatory approval processes - Secure resources, testing services, and support - Foster professional relationships - Manage revenue cycles - Put regulations into practice - Implement effective quality-control processes
Book Synopsis A Concise Guide to Observational Studies in Healthcare by : Allan Hackshaw
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.
