Clinical outcome study

This is the usual design for therapeutic devices, as opposed to diagnostic studies that compare test results with a reference. The choice of outcome measures and follow-up times shapes what the study can claim.

A study in which subjects are assigned to an intervention and then studied at planned intervals using validated assessment tools to assess clinical outcome parameters or their validated surrogates to determine the safety and effectiveness of the intervention.

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