Learning curve

A learning curve can make early results look worse than later ones. Study designs often plan for it, for example by analyzing the first cases at each site separately.

A graphical representation of the change in the rate of learning in the use of a medical device or, for a surgical implant, in the implantation procedure of the device. It can be measured in terms of the time taken to achieve desired outcomes or in the number of procedures until successful outcomes are assured.

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