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Research • Statistic & Theory
Designing Clinical Research, Fourth Edition
Stephen B. Hulley, MD, MPH
978-1-60831-804-9 • July 2013 • Softbound • 7” x 10”pp • 59Table
Designing Clinical Research
has been extensively revised and
continues to set the standard as a practical guide for doctors, nurses,
pharmacists, and other health professionals involved in all forms of
clinical, translational, and public health research. It presents advanced
epidemiologic concepts in a reader-friendly way, and suggests common
sense approaches to the challenging judgments involved in designing,
funding, and implementing.
Features
•
NEW!
Approaches to sample size estimation, keeping it simple
while covering more design options.
• Examples and ideas on what’s new in clinical research.
• Exercises that highlight major clinical research issues.
• Treatment of clinical trial design and implementation.
• Expanded and updated content in every chapter, with new material
on: non-inferiority trials for comparative effectiveness research
incidence-density case-control studies confounding and effect
modification; diagnostic test studies to inform prediction rules;
ethical aspects of whole genome sequencing; automated data
management approaches; new NIH grant-writing requirements.
• Color format, and Electronic access, powered by Inkling
™
as a
free companion to the text; viewable through your browser or
as a download to tablet or smartphone ; the complete text with
optimized navigation; note-sharing, highlighting and bookmarking
capability; cross-linking of references and content; rapid search
options linked to the new glossary.
Table of Contents
Section I:
Basic Ingredients
Ch. 1: Getting Started: The Anatomy and
Physiology of Clinical Research
Ch. 2: Conceiving the Research Question
and Developing the Study Plan
Ch. 3: Choosing the Study Subjects:
Specification, Sampling, and Recruitment
Ch. 4: Planning the Measurements: Precision,
Accuracy and Validity
Ch. 5: Getting Ready to Estimate Sample
Size: Hypotheses and Underlying Principles
Ch. 6: Estimating Sample Size and Power:
Applications and Examples
Section II:
Study Designs
Ch. 7: Designing Cross-Sectional and Cohort
Studies
Ch. 8: Designing Case-Control Studies
Ch. 9: Enhancing Causal Inference in
Observational Studies
Ch. 10: Designing a Randomized Blinded
Trial
Ch. 11: Alternative Trial Designs and
Implementation Issues
Ch. 12: Designing Studies of Medical Tests
Ch. 13: Research Using Existing Data
Section III:
Implementation
Ch. 14: Addressing Ethical Issues
Ch. 15: Designing Questionnaires, Interviews
and Online Surveys
Ch. 16; Data Management
Ch. 17: Implementing the Study and Quality
Control
Ch. 18: Community and International
Studies
Ch. 19: Writing and Funding a Research
Proposal