Statistical Considerations in Cervical Screening Cytology Device Evaluation

• Activity Number: 38 - Study Design: Historical Controls, Endpoint Timing, and Regulatory Considerations
• Type: Contributed
• Date/Time: Sunday, July 29, 2018 : 2:00 PM to 3:50 PM
• Sponsor: Section on Medical Devices and Diagnostics
• Author(s): Xiaoqin Xiong*
• Companies: Food and Drug Administration
• Keywords: Screening; Cytology; cervical cancer; Pap Test; study design

Abstract

Cervical cytology by Papanicolaou (Pap) smears is an effective means of screening for cervical premalignant and malignant conditions.

Cervical intra-epithelial neoplasia (CIN) and cervical cancer remain important health problems for women worldwide. The Cervical

cytologic diagnosis categories are ordinal data based on the Bethesday System. How to appropriately evaluate the device analytical and clinical performance face many layers of statistical challenges. In this talk, we will discuss some statistical challenges and issues in study design, data analysis, and sample size calculation.