A Note on Good Practice of Objective Propensity Score Design for Premarket Nonrandomized Medical Device Studies with an Example

ABSTRACT

In this short note, we highlight some key elements of the process of submitting an investigational device exemption of a nonrandomized clinical study that involves the use of propensity score methodology. Focus is given to the assessment of balance for propensity score stratification.

Keywords:

• Balance assessment
• Regulatory submission
• Stratification