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.

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.

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.

This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources

"The Lancet Handbook of Essential Concepts in Clinical Research speaks to two audiences: those who read and those who conduct research. Clinicians are medical detectives by training. For each patient, they assemble clinical clues to establish causes (e.g. diagnoses) of signs and symptoms. The task involves both clinical acumen and knowledge of medical research. This book helps guide clinicians through this detective work, by enabling them to make sense of research and to review medical literature critically. It will also be invaluable to researchers who conduct clinical research, particularly randomized controlled trials. Building on previously published, peer-reviewed articles from The Lancet, this handbook is essential for busy clinicians and active researchers interested in research methods."--BOOK JACKET.

This practical guide speaks to two audiences: those who read and those who conduct research. Clinicians are medical detectives by training. For each patient, they assemble clinical clues to establish causes of signs and symptoms. The task involves both clinical acumen and knowledge of medical research. This book helps guide clinicians through this detective work, by enabling them to make sense of research and to review medical literature critically. It will also be invaluable to researchers who conduct clinical research, particularly randomized controlled trials. Building on previously published, peer-reviewed articles from The Lancet, this handbook is essential for busy clinicians and active researchers interested in research methods. - Written by leaders in the field of clinical research who have published extensively with authorship of hundreds of articles in medical journals. - The authorship includes one of the three authors of the CONSORT guidelines for the reporting of randomized controlled trials. - The book presents the essential concepts to a wide array of topics including randomized control trials, descriptive studies, cohort studies, case-control studies, bias, and screening tests. - The book utilises a readable and humorous prose style, lightening what can be a difficult area for clinical readers. - Derived from decades of teaching clinical research in seminar settings the book will empower clinicians to make sense of, and critically appraise, current medical research and will enable researchers to enrich the quality of their work. For this Second Edition, the authors have revised and updated the original 16 chapters and added six new chapters. For busy clinicians and active researchers interested in research methods, this book provides helpful tools to derive satisfaction - indeed, fun - from clinical science.

LEARN THE EFFICIENT, EASY WAY TO CONDUCT MEDICAL RESEARCH PERFECT FOR ANYONE CONSIDERING A MEDICAL RESEARCH PROJECT! This concise handbook tells you everything you need to know about medical research. You will learn how to read, understand, and ultimately perform it. Medical Research Essentials walks you step by step through the entire research process, from how to read and critique an article, to presenting your own data. Filled with flowcharts, algorithms, diagrams, and tables, Medical Research Essentials is like having an experienced mentor at your side! THIS ULTIMATE HANDBOOK FOR INTERPRETING AND CONDUCTING MEDICAL RESEARCH OFFERS CONCISE COVERAGE OF: How to critically read and interpret medical literature The best methods of organizing and analyzing data Potential research projects that can be performed in a limited time frame How to design your own study and acquire funding Understanding and using medical statistics

N-of-1 trials, a type of individualized randomized controlled trial, are relevant to almost every discipline in medicine and psychology. They can tell the clinician with precision whether a treatment works in that individual, which distinguishes from the information available from most other trial designs. They have the potential to revolutionize the way clinical medicine is practiced. Whether you are a busy clinician, a researcher or a student, this book provides everything you need to know about N-of-1 trials. Written and edited by some of the world’s leading experts on N-of-1 trials, the book presents state of the art knowledge about N-of-1 trials, with chapters on ethics, statistics, health economics, design, analysis and reporting, and more. Full of examples and well illustrated, it is a comprehensive compendium of issues surrounding the design, conduct, interpretation and implementation of N-of-1 trials in a health system.

Now in its Fifth Edition, Clinical Epidemiology: The Essentials is a comprehensive, concise, and clinically oriented introduction to the subject of epidemiology. Written by expert educators, this text introduces students to the principles of evidence-based medicine that will help them develop and apply methods of clinical observation in order to form accurate conclusions. The Fifth Edition includes more complete coverage of systematic reviews and knowledge management, as well as other key topics such as abnormality, diagnosis, frequency and risk, prognosis, treatment, prevention, chance, studying cases and cause.

This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience.