Bias in clinical research

Abstract

The quality of a clinical study depends on internal and external factors. Studies have internal validity when, random error apart, reported differences between exposed and unexposed individuals can be attributed only to the exposure under investigation. Internal validity may be affected by bias, that is, by any systematic error that occurs in the design or in the conduction of a clinical research. Here we focus on two major categories of bias: selection bias and information bias. We describe three types of selection biases (incidence-prevalence bias, loss-to-follow-up bias, and publication bias) and a series of information biases (i.e. misclassification bias--recall bias, interviewer bias, observer bias, and regression dilution bias--and lead-time bias).