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.

BASIC INGREDIENTS

Getting Started: The Anatomy and Physiology of Clinical Research
Stephen B. Hulley, Thomas B. Newman, and Steven R. Cummings

Conceiving the Research Question
Steven R. Cummings, Warren S. Browner, and Stephen B. Hulley

Choosing the Study Subjects: Specification, Sampling, and Recruitment
Stephen B. Hulley, Thomas B. Newman, and Steven R. Cummings

Planning the Measurements: Precision and Accuracy
Stephen B. Hulley and Steven R. Cummings

Getting Ready to Estimate Sample Size: Hypotheses and Underlying Principles
Warren S. Browner, Thomas B. Newman, and Stephen B. Hulley

Estimating Sample Size and Power: Applications and Examples
Warren S. Browner, Thomas B. Newman, and Stephen B. Hulley

STUDY DESIGNS

Designing an Observational Study: Cohort Studies
Steven R. Cummings, Thomas B. Newman, and Stephen B. Hulley

Designing an Observational Study: Cross-sectional and Case-control Studies
Thomas B. Newman, Warren S. Browner, Steven R. Cummings, and Stephen B. Hulley

Enhancing Causal Inference in Observational Studies
Thomas B. Newman, Warren S. Browner, and Stephen B. Hulley

Designing a Randomized Blinded Trial
Steven R. Cummings, Deborah Grady, and Stephen B. Hulley

Alternative Trial Designs and Implementation Issues
Deborah Grady, Steven R. Cummings, and Stephen B. Hulley

Designing Studies of Medical Tests
Thomas B. Newman, Warren S. Browner, and Steven R. Cummings

Research Using Existing Databases: Secondary Data Analysis, Ancillary Studies, and Systematic Reviews
Deborah Grady and Norman Hearst

IMPLEMENTATION

Addressing Ethical Issues
Bernard Lo

Designing Questionnaires and Interviews
Steven R. Cummings and Stephen B. Hulley

Data Management
Michael A. Kohn

Implementing the Study: Pretesting, Quality Control, and Protocol Revisions
Stephen B. Hulley and Steven R. Cummings

Community and International Studies
Norman Hearst and Thomas Novotny

Writing and Funding a Research Proposal
Steven R. Cummings and Stephen B. Hulley

Chapter Exercises