Randomized study

A randomized design gives the strongest basis for comparing an investigational device with a control, which is why many pivotal studies use one. When randomization is not practical, the sponsor has to justify the alternative design and address the bias it brings.

A study in which participants are randomly (i.e., by chance) assigned to one of two or more interventions (or diagnostic tests) of a clinical study.

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