Controlled clinical study

A control makes the results easier to interpret and defend. Single-arm studies without a control rely on performance goals or historical data instead, which reviewers examine more closely.

A clinical study that evaluates the performance of the investigational device by comparison with results from a control group, a comparator device or a clinical reference standard.

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