Designing Clinical Research

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.