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

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.

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.

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 Tom Brody and published by Academic Press. This book was released on 2011-10-25 with total page 673 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design. - Provides extensive coverage of the "study schema" and related features of study design - Offers a "hands-on" reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design - Features examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study design - Integrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trials - Includes chapters on core material and important ancillary topics, such as package inserts, consent forms, and safety reporting forms used in the United States, England and Europe - For complimentary access to our sample chapter (chapter 24), please copy and paste this link into your browser: http://tinyurl.com/awwutvn

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.

Download or read book Fundamentals of Clinical Trials written by Lawrence M. Friedman and published by Springer Science & Business Media. This book was released on 1998 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.

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 540 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.

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

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 2024-07-01 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: Design and execute life-saving trials with this accessible resource Clinical trials have revolutionized the treatment of disease and the development of life-saving pharmaceuticals. They contribute decisively to diagnosis, the avoidance of early death, medical intervention and are central to the modern work of pharmaceutical producers. The design and execution of clinical trials is one of the fastest-growing and most important areas of medical and pharmaceutical research. A Concise Guide to Clinical Trials provides an accessible and comprehensive survey of clinical trials, their design, and their applications. Beginning with a taxonomy of trial types, the book overviews stages of analysis, ethical and legal requirements, and more. Now fully updated to reflect the latest research and clinical practice, it continues to be an indispensable resource for researchers and clinicians. Readers of the second edition of A Concise Guide to Clinical Trials will also find: New material on pharmaceutical trials, adaptive designs, and the use of “big data” The easy-to-use organization facilitates both first-time learning and reference Detailed treatment of concepts such as health technology assessments (HTA), patient and public involvement and engagement (PPIE), and more A Concise Guide to Clinical Trials is ideal for clinicians and healthcare professionals looking for a working knowledge of clinical trials, as well as for pharmaceutical workers and regulators looking to understand this vital aspect of the industry.

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.

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.

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 201 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.

Download or read book A Concise Guide to Nuclear Medicine written by Abdelhamid H. Elgazzar and published by Springer Science & Business Media. This book was released on 2011-05-10 with total page 167 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nuclear medicine is an important component of modern medicine. This easy-to-use book is designed to acquaint readers with the basic principles of nuclear medicine, the instrumentation used, the gamut of procedures available, and the basis for selecting specific diagnostic or therapeutic procedures and interpreting results. After an introductory chapter on the history, technical basis, and scope of nuclear medicine, a series of chapters are devoted to the application of nuclear medicine techniques in the different body systems. In addition, the use of nuclear medicine methods within oncology is carefully examined, covering diagnosis, staging, assessment of treatment response, radiotherapy planning, and the sentinel node technique. The book concludes with a chapter devoted to nuclear medicine therapy. This practical and up-to-date guide to nuclear medicine is ideal for beginners and will also help professionals who need to retrieve useful information rapidly.

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.

Download or read book A Guide to the Scientific Career written by Mohammadali M. Shoja and published by John Wiley & Sons. This book was released on 2020-01-09 with total page 786 pages. Available in PDF, EPUB and Kindle. Book excerpt: A concise, easy-to-read source of essential tips and skills for writing research papers and career management In order to be truly successful in the biomedical professions, one must have excellent communication skills and networking abilities. Of equal importance is the possession of sufficient clinical knowledge, as well as a proficiency in conducting research and writing scientific papers. This unique and important book provides medical students and residents with the most commonly encountered topics in the academic and professional lifestyle, teaching them all of the practical nuances that are often only learned through experience. Written by a team of experienced professionals to help guide younger researchers, A Guide to the Scientific Career: Virtues, Communication, Research and Academic Writing features ten sections composed of seventy-four chapters that cover: qualities of research scientists; career satisfaction and its determinants; publishing in academic medicine; assessing a researcher’s scientific productivity and scholarly impact; manners in academics; communication skills; essence of collaborative research; dealing with manipulative people; writing and scientific misconduct: ethical and legal aspects; plagiarism; research regulations, proposals, grants, and practice; publication and resources; tips on writing every type of paper and report; and much more. An easy-to-read source of essential tips and skills for scientific research Emphasizes good communication skills, sound clinical judgment, knowledge of research methodology, and good writing skills Offers comprehensive guidelines that address every aspect of the medical student/resident academic and professional lifestyle Combines elements of a career-management guide and publication guide in one comprehensive reference source Includes selected personal stories by great researchers, fascinating writers, inspiring mentors, and extraordinary clinicians/scientists A Guide to the Scientific Career: Virtues, Communication, Research and Academic Writing is an excellent interdisciplinary text that will appeal to all medical students and scientists who seek to improve their writing and communication skills in order to make the most of their chosen career.

Download or read book Textbook of Clinical Trials written by David Machin and published by John Wiley & Sons. This book was released on 2007-01-11 with total page 784 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now published in its Second Edition, the Textbook of Clinical Trials offers detailed coverage of trial methodology in diverse areas of medicine in a single comprehensive volume. Praise for the First Edition: "... very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas." BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2, February 2005 The book’s main concept is to describe the impact of clinical trials on the practice of medicine. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. The sections provide a background to the disease area and general clinical trial methodology before concentrating on particular problems experienced in that area. Specific examples are used throughout to address these issues. The Textbook of Clinical Trials, Second Edition: Highlights the various ways clinical trials have influenced the practice of medicine in many therapeutic areas Describes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fields Additional therapeutic areas are included in this Second Edition to fill gaps in the First Edition as the number and complexity of trials increases in this rapidly developing area Newly covered or updated in the Second Edition: general surgery, plastic surgery, aesthetic surgery, palliative care, primary care, anaesthesia and pain, transfusion, wound healing, maternal and perinatal health, early termination, organ transplants, ophthalmology, epilepsy, infectious disease, neuro-oncology, adrenal, thyroid and urological cancers, as well as a chapter on the Cochrane network An invaluable resource for pharmaceutical companies, the Textbook of Clinical Trials, Second Edition appeals to those working in contract research organizations, medical departments and in the area of public health and health science alike.