Section I Basic Ingredients

1  Getting Started: The Anatomy and Physiology of Clinical Research

Stephen B. Hulley, Thomas B. Newman, and Steven R. Cummings

2  Conceiving the Research Question and Developing the Study Plan

Steven R. Cummings, Warren S. Browner, and Stephen B. Hulle

3  Choosing the Study Subjects: Specification, Sampling, and Recruitment

Sephen B. Hulley, Thomas B. Newman, and Steven R. Cummings

4  Planning the Measurements: Precision, Accuracy and Validity

Stephen B. Hulley, Thomas B. Newman and Steven R. Cummings

5  Getting Ready to Estimate Sample Size: Hypotheses and Underlying Principles

Warren S. Browner, Thomas B. Newman, and Stephen B. Hulley

6  Estimating Sample Size and Power: Applications and Examples

Warren S. Browner, Thomas B. Newman, and Stephen B. Hulley

Section II Study Designs

7  Designing Cross-Sectional and Cohort Studies

Stephen B. Hulley, Steven R. Cummings, and Thomas B. Newman

8  Designing Case–Control Studies

Thomas B.Newman, Warren S.Browner, Steven R.Cummings, and Stephen B.Hulley

9  Enhancing Causal Inference in Observational Studies

Thomas B. Newman, Warren S. Browner, and Stephen B. Hulley

10  Designing a Randomized Blinded Trial

Steven R. Cummings, Deborah Grady, and Stephen B. Hulley

11  Alternative Trial Designs and Implementation Issues

Deborah Grady, Steven R. Cummings, and Stephen B. Hulley

12  Designing Studies of Medical Tests

Thomas B.Newman, Warren S.Browner, Steven R.Cummings, and Stephen B. Hulley

13  Research Using Existing Data

Deborah Grady, Steven R. Cummings and Stephen B. Hulley

Section III Implementation

14  Addressing Ethical Issues

Bernard Lo and Deborah Grady

15  Designing Questionnaires, Interviews and Online Surveys

Steven R. Cummings, Michael A. Kohn, and Stephen B. Hulley

16   Data Management

Michael A. Kohn, Thomas B. Newman, and Stephen B. Hulley

17  Implementing the Study and Quality Control

Deborah Grady and Stephen B. Hulley

18  Community and International Studies

Norman Hearst and Thomas Novotny

19  Writing and Funding a Research Proposal

Steven R. Cummings and Stephen B. Hulley

Exercises

Answers to Exercises

Glossary