Understanding Clinical Research


Book Description

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




Understanding Medical Research


Book Description

Medical students and junior and senior doctors are frequently called upon to give research presentations, write reports, and answer exam questions on specific areas of medical research. Understanding Medical Research: The Studies That Shaped Medicine is an exciting new title that offers a unique and valuable approach to understanding historically influential studies in important areas of medicine. Featuring chapters from Sir Liam Donaldson and Sir David Weatherall, amongst others, world leading researchers identify ten primary research papers that have shaped the direction of research in their given topic, examining why they were carried out, key findings, and how they changed the field. Each chapter also contains short sections on ‘Key Questions Remaining’ which outline outstanding areas where further research is needed, and a link to ‘Key Laboratories/Clinics’ which point the reader to major research groups of international standing. Covering the seminal research in core areas of medicine, Understanding Medical Research provides an authoritative framework on each topic for medical students and healthcare professionals.




Understanding Health Care Outcomes Research


Book Description

Health Sciences & Professions




Beyond the HIPAA Privacy Rule


Book Description

In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.




Understanding Medical Education


Book Description

Created in partnership with the Association for the Study of Medical Education (ASME), this completely revised and updated new edition of Understanding Medical Education synthesizes the latest knowledge, evidence and best practice across the continuum of medical education. Written and edited by an international team, this latest edition continues to cover a wide range of subject matter within five broad areas – Foundations, Teaching and Learning, Assessment and Selection, Research and Evaluation, and Faculty and Learners – as well as featuring a wealth of new material, including new chapters on the science of learning, knowledge synthesis, and learner support and well-being. The third edition of Understanding Medical Education: Provides a comprehensive and authoritative resource summarizing the theoretical and academic bases to modern medical education practice Meets the needs of all newcomers to medical education whether undergraduate or postgraduate, including those studying at certificate, diploma or masters level Offers a global perspective on medical education from leading experts from across the world Providing practical guidance and exploring medical education in all its diversity, Understanding Medical Education continues to be an essential resource for both established educators and all those new to the field.




Principles and Practice of Clinical Research


Book Description

The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government




Understanding Clinical Data Analysis


Book Description

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.




Using and Understanding Medical Statistics


Book Description

Abstract: A textbook is intended to serve as a study guide for medical students for becoming well-informed regarding medical statistics for subsequent use in medical research. The theme of the text is to describe the statistical methodology frequently found in published medical research, particularly in the area of chronic diseases. Included are: basic concepts; text of significance; various statistical tests and tables; the use and comparison of survival curves; normally distributed data and their analysis; linear regression models for medical data; other regression models; the quality of data; clinical trial designs; and considerations of sample size. Specific applications to epidemiological studies also are described. Numerous tables, illustrations, and examples are given throughout the text.




The Comprehensive Guide To Clinical Research


Book Description

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




Practical Statistics for Medical Research


Book Description

Practical Statistics for Medical Research is a problem-based text for medical researchers, medical students, and others in the medical arena who need to use statistics but have no specialized mathematics background. The author draws on twenty years of experience as a consulting medical statistician to provide clear explanations to key statistical concepts, with a firm emphasis on practical aspects of designing and analyzing medical research. Using real data and including dozens of interesting data sets, this bestselling text gives special attention to the presentation and interpretation of results and the many real problems that arise in medical research.