HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Submit a response Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Hartung, D. M. Articles by Touchette, D. Search for Related Content PubMed PubMed Citation Articles by Hartung, D. M. Articles by Touchette, D.

DANIEL M. HARTUNG, M.P.H., PHARM.D., is Assistant Professor, Pharmacy Practice, College of Pharmacy, Oregon State University, Portland. DANIEL TOUCHETTE, M.A., PHARM.D., is Assistant Professor, Pharmacy Practice, and Core faculty, Center for Pharmacoeconomic Research, College of Pharmacy, University of Illinois at Chicago, Chicago.

Address correspondence to Dr. Hartung at the College of Pharmacy, Oregon State University, 3303 Southwest Bond Avenue, CH12C, Portland, OR 97239 (hartungd{at}ohsu.edu).

Purpose. Basic concepts and terminology of clinical research design are presented for new clinical investigators. Summary. Clinical research, research involving human subjects, can be described as either observational or experimental. The findings of all clinical research can be threatened by issues of bias and confounding. Biases are systematic errors in how study subjects are selected or measured, which result in false inferences. Confounding is a distortion in findings that is attributable to mixing variable effects. Uncontrolled observation research is generally more prone to bias and confounding than experimental research. Observational research includes designs such as the cohort study, case–control study, and cross-sectional study, while experimental research typically involves a randomized controlled trial (RCT). The cohort study, which includes the RCT, defines subject allocation on the basis of exposure interest (e.g., drug, disease-management program) and follows the patients to assess the outcomes. The case–control study uses the primary outcome of interest (e.g., adverse event) to define subject allocation, and different exposures are assessed in a retrospective manner. Cross-sectional research evaluates both exposure and outcome concurrently. Each of these design methods possesses different strengths and weaknesses in answering research questions, as well as underlying many study subtypes. Conclusion. While experimental research is the strongest method for establishing causality, it can be difficult to accomplish under many scenarios. Observational clinical research offers many design alternatives that may be appropriate if planned and executed carefully. Index terms: Clinical studies; Methodology; Nomenclature