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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