An Introduction To Clinical Research

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.

Here is an ideal introduction to research methods for clinicians, fellows, residents, and medical students. Written in a clear, easy-to-understand style, it outlines the steps that should be followed in order to organize and implement a typical investigation. Emphasizing the anticipation of future difficulties and the benefits of early planning, the authors discuss the types of questions that should be asked, how to design a study, and methods of data acquisition and analysis. Many examples are presented to illustrate the textual material, and extensive bibliography sections at the end of each chapter direct readers to published articles and texts that will provide further information.

Concise, fast-paced, intensive introduction to clinical research design for students and clinical research professionals Readers will gain sufficient knowledge to pass the United States Medical Licensing Examination part I section in Epidemiology

In its extensively revised and updated Second Edition, this book provides a solid foundation for readers interested in clinical research. Discussion encompasses genetic, pharmacoepidemiologic and implementation research. All chapters have been updated with new information and many new tables have been added to elucidate key points. The book now offers discussion on how to handle missing data when analyzing results, and coverage of Adaptive Designs and Effectiveness Designs and new sections on Comparative Effectiveness Research and Pragmatic Trials. Chapter 6 includes new material on Phase 0 Trials, expanded coverage of Futility Trials, a discussion of Medical Device approval, Off Label Drug use and the role of the FDA in regulating advertising. Additional new information includes the role of pill color and shape in association with the placebo effect and an examination of issues surrounding minority recruitment. The final chapter offers a new section on manuscript preparation along with a discussion of various guidelines being adopted by journals: CONSORT, STROBE, PRISMA, MOOSE and others; and coverage of Conflicts of Interest, Authorship, Coercive Citation, and Disclosures in Industry-Related Associations. Building on the strengths of its predecessor in its comprehensive approach and authoritative advice, the new edition offers more of what has made this book a popular, trusted resource for students and working researchers alike.

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

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.

This concise book is addressed to researchers, clinical investigators, as well as practicing physicians and surgeons who are interested in the fields of clinical research and trials. It covers some important topics related to clinical trials including an introduction to clinical trials, some aspects concerning clinical trials in pediatric age group, and the unique aspects of the design of clinical trials on stem cell therapy.