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Understanding Clinical Investigations
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Book Synopsis Understanding Clinical Investigations by : Susan Skinner
Download or read book Understanding Clinical Investigations written by Susan Skinner and published by Elsevier Health Sciences. This book was released on 2005-06-02 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: This indispensable handbook provides easily accessible explanations of the common investigations carried out on all body systems. It addresses the relationship between normal physiology and disease processes and the place of clinical investigation within these events. The rationale for investigation is made clear and some guidance for further care is offered. In this new edition each investigation has been updated in line in the light of recent guidelines and practice. New material has been added including chromosome studies and blood cholesterol values. Designed to give quickly referenced guidance on a broad spectrum of clinical investigation and monitoring, it will be helpful to all nursing staff and will assist in giving explaining tests to patients. Comprehensive range of common clinical investigations Combines normal physiology and clinical investigations and pathophysiology Appendix of normal values New design and format Each investigation has been updated in line in the light of recent guidelines and practice. New material has been added including chromosome studies and blood cholesterol values
Book Synopsis Understanding Clinical Research by : Renato D. Lopes
Download or read book Understanding Clinical Research written by Renato D. Lopes and published by McGraw Hill Professional. This book was released on 2013-05-22 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples--drawn from the authors' broad experience--that put chapter concepts into action and contribute to a working knowledge of integral research techniques. FEATURES: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials
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 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.
Author :Lawrence M. Friedman Publisher :Springer Science & Business Media ISBN 13 :9780387985862 Total Pages :384 pages Book Rating :4.9/5 (858 download)
Book Synopsis Fundamentals of Clinical Trials by : Lawrence M. Friedman
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.
Book Synopsis The Role of Purchasers and Payers in the Clinical Research Enterprise by : Institute of Medicine
Download or read book The Role of Purchasers and Payers in the Clinical Research Enterprise written by Institute of Medicine and published by National Academies Press. This book was released on 2002-06-14 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective.
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 Understanding Clinical Data Analysis by : Ton J. Cleophas
Download or read book Understanding Clinical Data Analysis written by Ton J. Cleophas and published by Springer. This book was released on 2016-08-23 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook consists of ten chapters, and is a must-read to all medical and health professionals, who already have basic knowledge of how to analyze their clinical data, but still, wonder, after having done so, why procedures were performed the way they were. The book is also a must-read to those who tend to submerge in the flood of novel statistical methodologies, as communicated in current clinical reports, and scientific meetings. In the past few years, the HOW-SO of current statistical tests has been made much more simple than it was in the past, thanks to the abundance of statistical software programs of an excellent quality. However, the WHY-SO may have been somewhat under-emphasized. For example, why do statistical tests constantly use unfamiliar terms, like probability distributions, hypothesis testing, randomness, normality, scientific rigor, and why are Gaussian curves so hard, and do they make non-mathematicians getting lost all the time? The book will cover the WHY-SOs.
Book Synopsis Understanding Clinical Papers by : David Bowers
Download or read book Understanding Clinical Papers written by David Bowers and published by John Wiley & Sons. This book was released on 2006-05-01 with total page 247 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now in its Second Edition, this book helps to unravel the processof evidence-based practice, which requires clinicians to evaluateand collate information from the journals they read.Understanding Clinical Papers, SecondEdition uses actual papers to illustrate how tounderstand and evaluate published research, but goes beyond this toprovide an explanation of a range of important research-relatedtopics. Understanding Clinical Papers, Second Edition: Covers everything necessary to understand a clinical researchpaper Examples are illustrated and based uniquely on tables,abstracts and exerts from published clinical research papers Amazingly clear, lively, accessible style The new edition has been markedly improved and extended,containing, for example, new material on measurement scales,systematic reviews, writing a paper, statistics software andcritical appraisal “What strikes the reader... straight away isclarity… promises to become a recommended text forundergraduate and postgraduate courses." JOURNAL OF TROPICALPEDIATRICS “The writing style is amazingly clear and does notrequire formal course work in biostatistics orepidemiology…We strongly recommend it for beginners and foreasy entry into a complex domain and to experts who we think willenjoy it and who will find it useful as they teach, advise and helpothers.” QUALITY IN HEALTH CARE “What makes this book unique is that each pointpresented is illustrated with excerpts from actual papers, oftenthree or four per chapter... this is a very effective teachingdevice." JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION “This book should be an essential addition to thepersonal libraries of all health care workers who need to usearticles in journals. In these days of evidence-based medicine,this should apply to all physicians, nurses and other healthprofessionals.” ONCOLOGY Understanding Clinical Papers, Second Edition isan invaluable resource for everyone involved directly or indirectlyin health care – an ultimate guide for those who readclinical literature.
Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Book Synopsis Clinical Trials by : Lorna Speid, Ph.D
Download or read book Clinical Trials written by Lorna Speid, Ph.D and published by Oxford University Press. This book was released on 2010-07-30 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: Every year, hundreds of thousands of healthy volunteers and patients worldwide undertake the journey through the maze that can be clinical trials. Research participants take part in clinical trials for a variety of reasons. The healthy volunteers may be seeking extra money to pay off college tuition, or they may know someone who is suffering and would potentially benefit from the results of the trial. The patient who is terminally ill might participate in a clinical trial simply as a last hope for a cure. Whatever the goals, though, most participants will experience the same sense of bewilderment as they encounter the jargon and medical terminology that they will hear and have to read about and understand during the course of the clinical trial. Clinical Trials: What Patients and Volunteers Need to Know demystifies the entire process, focusing on the process of drug development, and the clinical trial itself. Writing from a lifetime of experience, the author provides important questions to ask those running a clinical trial, key definitions and terms for a participant to know and understand, as well as anecdotes illustrating the clinical trial process. The author also grapples with the idea of "informed consent," providing mechanisms for patients and volunteers to feel fully informed before signing up for the trial. A vital resource for those who are considering enrolling in a clinical trial, or for the parents, friends, or relatives of those involved in a clinical trial, this book takes away the mystery and allows the participant to enter a clinical trial feeling both informed and confident.
Book Synopsis An Introduction to Clinical Research by : Piers Page
Download or read book An Introduction to Clinical Research written by Piers Page and published by OUP Oxford. This book was released on 2011-11-10 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical book is written specifically for junior doctors by a team of highly experienced authors, as an introductory guide to clinical research. It covers all areas that a junior doctor needs to consider, including funding, study design, ethics, data analysis, disseminating findings, and furthering one's research career. It presents a balance view of clinical research and is written by authors actively involved in clinical research both at the 'coal-face' and at a more supervisory level. Research can be a difficult process and it is essential to make sure that the project is set up in the correct way in order to get verifiable results. This easy-to-read guide is available to help junior doctors develop a good study design and present evidence of a sound academic practice, which will make obtaining funding more likely and be time-efficient. Getting started early in research and developing a solid, gradual understanding of clinical research through using this approachable book will be of huge benefit to junior doctors and their discipline.
Book Synopsis The Prevention and Treatment of Missing Data in Clinical Trials by : National Research Council
Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.
Book Synopsis Design and Analysis of Clinical Trials by : Shein-Chung Chow
Download or read book Design and Analysis of Clinical Trials written by Shein-Chung Chow and published by Wiley-Interscience. This book was released on 1998-06-23 with total page 680 pages. Available in PDF, EPUB and Kindle. Book excerpt: A unique, unifying treatment for statistics and science in clinical trials What sets this volume apart from the many books dealing with clinical trials is its integration of statistical and clinical disciplines. Stressing communication between biostatisticians and clinical scientists, this work clearly relates statistical interpretation to clinical issues arising in different stages of pharmaceutical research and development. Plus, the principles presented here are universal enough to be easily adapted in non-biopharmaceutical settings. Design and Analysis of Clinical Trials tackles concepts and methodologies. It not only covers statistical basics such as uncertainty and bias, design considerations such as patient selection, randomization, and the different types of clinical trials but also deals with various methods of data analysis, group sequential procedures for interim analysis, efficacy data evaluation, analysis of safety data, and more. Throughout, the book: * Surveys current and emerging clinical issues and newly developed statistical methods * Presents a critical review of statistical methodologies in various therapeutic areas * Features case studies from actual clinical trials * Minimizes the mathematics involved, making the material widely accessible * Offers each chapter as a self-contained entity * Includes illustrations to highlight the text This monumental reference on all facets of clinical trials is important reading for physicians, clinical and medical researchers, pharmaceutical scientists, clinical programmers, biostatisticians, and anyone involved in this burgeoning area of clinical research. It can also be used as a textbook in graduate-level courses in the field.
Book Synopsis Clinical Trials and Human Research by : Fay A. Rozovsky
Download or read book Clinical Trials and Human Research written by Fay A. Rozovsky and published by Jossey-Bass. This book was released on 2003-06-10 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This easy-to-read reference book provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a broad range of topics, such as consent, confidentiality, subject recruitment and selection, the role of the investigator and Institutional Review Board, it offers timely and useful strategies for achieving regulatory compliance while reducing liability. In addition, insurance, quality management, accreditation, and risk management are topics examined in the book. The practical insights found in this volume are not found in other books on the subject. Clinical Trials and Human Research is a practical tool to help anyone involved in clinical research.
Book Synopsis Understanding Clinical Research by : Kathryn Biddle
Download or read book Understanding Clinical Research written by Kathryn Biddle and published by Scion Publishing Ltd. This book was released on 2023-05-17 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is important for healthcare professionals to understand the basics of clinical research. This book offers a thorough explanation of the principles of clinical research, alongside a wide range of worked examples which show how these principles are applied in practice. Understanding Clinical Research takes readers from how to develop research questions, through the design of research studies, to disseminating research findings. Ethical considerations, research integrity, patient involvement, and study funding are all covered, along with an introduction to the key statistical methods needed for data analysis. Ideal for any healthcare professional: interested in understanding more about the development of evidence-based practice wanting to undertake research but not sure where to start considering or just starting a PhD / MD, or a PGCert in Research Studies
Book Synopsis Understanding Laboratory Investigations by : Chris Higgins
Download or read book Understanding Laboratory Investigations written by Chris Higgins and published by John Wiley & Sons. This book was released on 2012-12-14 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this book is to help nurses, midwives and health professionals to better understand how the work of clinical laboratories contributes to patient care. It answers the following questions: Why is this test being ordered on my patient? What sort of sample is required? How is that sample obtained? And most importantly: What is the significance of the test result for my patient? Retaining its accessible and user-friendly style, the aim of this book remains the same: to provide nurses with as much relevant information as possible about the most commonly requested laboratory rests. This is not a book about laboratory technique - its focus is on the clinical significance of test results, and therefore the patient. The third edition is more comprehensive in terms of the number of tests discussed, incorporates colour to aid the accessibility, and includes more paediatric content.
