A Note on Good Practice of Objective Propensity Score Design for Premarket Nonrandomized Medical Device Studies with an Example. (2nd July 2016)

• Record Type: Journal Article
• Authors: Li, Heng; Mukhi, Vandana; Lu, Nelson; Xu, Yun-Ling; Yue, Lilly Q.
• Is Part Of: Statistics in biopharmaceutical research. Volume 8:Number 3(2016)
• Page Start: 282
• Page End: 286
• Publication Date: 2016-07-02
• Subjects: Balance assessment -- Regulatory submission -- Stratification; Pharmacy -- Statistical methods -- Periodicals; Pharmaceutical biotechnology -- Statistical methods -- Periodicals; Biopharmaceutics -- Periodicals; Biometry -- Periodicals; Pharmacy -- Statistical methods; Periodicals; 615.190727
• DOI: 10.1080/19466315.2016.1148071
• Languages: English
• ISSNs: 1946-6315

Abstract

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.