Sperimentazione clinica

Bridge the gap between research and practice with DePoy and Gitlin's Introduction to Research: Understanding and Applying Multiple Strategies, 4th Edition. This completely updated, user-friendly text helps you better understand not only the research process, but also research designs and their applications to the real world of clinical practice. Covering multiple research strategies (including both qualitative and quantitative research), it gives you a balanced approach to various research traditions, addressing the key issues that are emerging in today's health care environment.

Ideal for clinical students including medical, nursing, pharmacy, dental, physician assistant and more! Evidence-based information plays a critical role in clinical practice decisions. Secondary sources are often unreliable; it's up to the student, then, to critically assess peer-reviewed research literature. Using a highly structured yet accessible method, this best-selling text teaches students to critically analyze research from primary sources. Step-by-step approach- learn to recognize a meaningful study, clues to potential study flaws, and ways to apply solid evidence in clinical practice. Simple 6-point framework- learn to evaluate studies in terms of the author's trademark mnemonic device, M.A.A.R.I.E. (Methods, Assignment, Assessment, Results, Interpretation and Extrapolation). Unique Learning Aids - question checklists, real-world scenarious, flaw-catching exercises and more help to make complex concepts easy to grasp. New! New chapters cover safety, prediction and decision rules, and translating research into practice. "Learn More" boxes illustrate key concepts. Clinically oriented "Mini-Studies" demonstrate what can go wrong and how to get it right. Research topics include ethics, the role of Institutional Review Boards (IRBs), and advances in randomized controlled trials and observational studies. FREE Online Support! (with the purchase of the book) For Students: interactive Q&A for every chapter; M.A.A.R.I.E. framework and flaw-catching exercises; chapter objectives; and, flash Card interactive glossary. For Faculty: All of the student resources plus: instructor's guide with "tips on teaching" based on Dr. Riegelman's 30+ years of teaching from the text; syllabus suggestions for applying the text in semester-long courses, mini-courses, and as part of Journal Clubs; and, powerpoints designed to assist lectures Class-tested exam questions for each chapter.

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.

"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.

This popular reference facilitates diagnostic and therapeutic decision making for a wide range of common and often complex problems faced in outpatient and inpatient medicine. Comprehensive algorithmic decision trees guide you through more than 245 disorders organized by sign, symptom, problem, or laboratory abnormality. The brief text accompanying each algorithm explains the key steps of the decision making process, giving you the clear, clinical guidelines you need to successfully manage even your toughest cases.

Struggling to do a project or dissertation, evaluate published research or conduct your own research? Help is at hand with this 5th edition of "Research Methods for Clinical Therapists", which explains, in a clear and simple manner, how to evaluate existing research and how to conduct your own research. Aimed at undergraduate and postgraduate students, as well as the practising health care professional, the focus of the text is the design and analysis of experimental studies. These are vital to the effectiveness studies that are central to the work of the healthcare professional. Specific examples from different areas of healthcare are used to explain the core research concepts and relate them to clinical situations. Statistical theory and jargon are kept to a minimum.

Effective communication is the ultimate, but often daunting, purpose of any piece of medical research. Medical Writing: A Prescription for Clarity provides practical information enabling first drafts to be turned into clear, simple, unambiguous text, without loss of individuality. Written by a medical consultant and an experienced medical editor, it is sympathetic to the problems and needs of medical writers. Like the preceding two editions, this expanded third edition deals with the basic craft of writing for publication, from spelling and grammar to choosing the best word or phrase. Whether writing a simple clinical report or thesis, wanting to supervise others, or wanting just to develop greater skill in effective writing, this book is the ideal guide and reference. Clear, simple and precise, and illustrated with apt cartoons, this is an invaluable handbook.

This book is a friendly jargon buster, which aims to demystify clinical trials. It is divided into five sections: fundamentals of trial design, alternative trial designs, basics of statistical analysis, special trial issues in data analysis, and reporting of trials. Using simple language the book explains with illustrations of numerous trial examples, the conceptual and methodological issues that occur at all stages of clinical trial covering trial design, conduct, analysis and reporting. The book is an educational and approachable reference in a difficult area of medicine where clinicians often feel uncertain and this material helps them review, appraise and publish trials and clinical evidence. The audience for the book includes physicians, statisticians, pharmacists, medical students, clinical researchers, medical writers, data managers, study co-ordinators, pharmaceutical sales representatives, and financial (medical) analysts.

This volume is a comprehensive textbook for investigators entering the rapidly growing field of translational and experimental clinical research. The book offers detailed guidelines for designing and conducting a study and analyzing and reporting results and discusses key ethical and regulatory issues. Chapters address specific types of studies such as clinical experiments in small numbers of patients, pharmacokinetics and pharmacodynamics, and gene therapy and pharmacogenomic studies. A major section describes modern techniques of translational clinical research, including gene expression, identifying mutations and polymorphisms, cloning, transcriptional profiling, proteomics, cell and tissue imaging, tissue banking, evaluating substrate metabolism, and in vivo imaging.