Bias

Bias cannot be fixed by enrolling more subjects, because it is not random. Study design choices such as randomization, blinding and a suitable control are the main ways to limit it.

The introduction of systematic errors from the truth. In a clinical investigation, bias can lead to incorrect conclusions about what the study shows.

FDA guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013), Section 11, Glossary