Essentials of Clinical Research
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.
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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
Implementation Research Beyond the Traditional Randomized Controlled Trial
Research Methodology for Studies of Diagnostic Tests
Statistical Power and Sample Size Some Fundamentals for Clinician Researchers
Association Cause and Correlation
Bias Confounding and Effect Modification Interaction
Its All About Uncertainty
Grant and Manuscript Writing
The Media and Clinical Research
Data Safety and Monitoring Boards DSMBs
Metaanalysis EvidenceBased Medicine and Clinical Guidelines
Research Methods for Genetic Studies
Research Methods for Pharmacoepidemiology Studies