文档介绍：Special Feature
A Primer on the Design, Conduct, and Interpretation of
Clinical Trials
Lawrence J. Appel
Departments of Medicine, Epidemiology, and International Health (Human Nutrition), Johns Hopkins University,
Baltimore, Maryland
Clinical trials are an especially powerful study design that often guides health care policy and clinical practice. Indeed,
well-designed and rigorously conducted trials can establish the etiologic relevance of modifiable risk factors and the benefits
(and risks) of candidate therapies. Contemporary schema that classify evidence place results from randomized trials at the
pinnacle of evidence. The primary objective of this article is to provide an overview of the design, conduct, and interpretation
of trials with an emphasis on aspects that are relevant to nephrology.
Clin J Am Soc Nephrol 1: 1360–1367, 2006. doi:
linical trials are experiments that are conducted in Core Design
humans and are designed to test the effects of a treat- The mon type of design is a parallel-arm trial with
C ment or prevention strategy on prespecified out- two or more groups: parison group and at least one new
comes. As an experiment, a trial attempts to establish and (or active) therapy group (Figure 2). In such a design, partici-
maintain a contrast in therapies between randomly assigned pants remain assigned to their randomiz