Essentials of Clinical Research

This book provides a solid foundation in clinical research. This new edition offers discussion on how to handle missing data, coverage of adaptive designs and effectiveness designs, and new sections on comparative effectiveness research and pragmatic trials.

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 preparationalong 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.

Thoroughly updated and expanded for the Second Edition Includes new material on the net reclassification index; the p value and Bayesian approaches and more Offers new discussion of clinical practice guidelines and the different ways of grading evidence Includes supplementary material: sn.pub/extras

Inhalt

Preface.- The Beginning, Historical Aspects of Clinical Research, Clinical Research: Definitions, Anatomy and Physiology, and the Quest for Universal Truth.- Introduction to Clinical Research Concepts, Essential Characteristics of Clinical Research, Overview of Clinical Research Study Designs.- A Focus on Clinical Trials.- Alternative Interventional Study Designs.- Phase 4 (Postmarketing) Research.- The Role of the USA Food and Drug Administration in Clinical Research.- The Placebo and Nocebo Effect.- Recruitment and Retention in Clinical Research.- Data Safety and Monitoring Boards (DSMBs).- Meta-analysis, Evidence Based Medicine, and Clinical Guidelines.- Research Methods for Genetic Studies.- Research Methods for Pharmacoepidemiology Studies.- Implementation Research: Beyond the Traditional Randomized Controlled Trial.- Research Methodology for Studies of Diagnostic Tests.- Statistical Power & Sample Size: Some Fundamentals For Clinician Researchers.- Association,Cause, and Correlation.- Bias, Confounding, and Effect Modification (Interaction).- It's All About Uncertainty.- Grant and Manuscript Writing.- The Media and Clinical Research.- Mentoring and the Mentee.- Presentation Skills: How to Present Research Results.