Understanding Clinical Investigations

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

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

Clinical Investigations at a Glance The market-leading at a Glance series is popular among healthcare students and newly qualified practitioners, for its concise and simple approach and excellent illustrations. Each bite-sized chapter is covered in a double-page spread with clear, easy-to-follow diagrams, supported by succinct explanatory text. Covering a wide range of topics, books in the at a Glance series are ideal as introductory texts for teaching, learning and revision, and are useful throughout university and beyond. Everything you need to know about Clinical Investigations... at a Glance! Clinical Investigations at a Glance provides an up-to-date, evidence-based overview of diagnostic investigations, looking at their choice, importance and interpretation for commonly presenting symptoms and conditions. Designed to help develop the evidence-based use of investigations and interpret results properly, the book provides a unique perspective on many critical issues in medical testing, with the aim of improving diagnostic accuracy and reducing unnecessary tests or harm. Clinical Investigations at a Glance is structured in three parts: an overview of tests; common presentations (such as chest pain, nausea and vomiting, weight loss and anaemia); and conditions organized by body system, such as cardiovascular disease, respiratory disease and nephrology. Key features include: How to interpret investigations, using high quality illustrations to compare ‘normal’ and ‘diseased’ results Evidence-based, including references How to select the most appropriate investigation, the accuracy of tests and how to manage incidental findings For more information on the complete range of Wiley medical student and junior doctor publishing, please visit: www.wileymedicaleducation.com To receive automatic updates on Wiley books and journals, join our email list. Sign up today at www.wiley.com/email All content reviewed by students for students Wiley Medical Education books are designed exactly for their intended audience. All of our books are developed in collaboration with students. This means that our books are always published with you, the student, in mind. If you would like to be one of our student reviewers, go to www.reviewmedicalbooks.com to find out more. This title is also available as an e-book. For more details, please see www.wiIey.com/buy/9781118759325

A hands-on quick reference guide to a wide range of clinical investigations. Uniquely combines normal physiology with clinical examinations and pathophysiology. Also features a useful appendix of normal values.

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.

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.

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.

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.

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