P125: Interactive Data Driven Platform for Detecting, Extracting, and Adjudicating Secondary Primary Malignancies in Safety Database

Poster Presenter

Sahith Doppalapudi

Sr. Manager, PV Analytics Center of Excellence
Bristol-Myers Squibb Company
United States

Objectives

Health authorities require review and submission of Secondary Primary Malignancy (SPM) cases, which historically was done manually and required significant resources. The platform aims to reduce the overall review time and provide submission-ready cases that can be shared internally and externally

Method

The process involved configuring approved indication terms in the persistent layer, creating an algorithm in the persistent layer to identify SPM cases, developing an interface for users to extract cases based on parameters, and comparing the interface output with manual review.

Results

Based on the parameters selected by the users, the interface was able to identify and extract the SPM cases for the product of interest, which were then adjudicated by physicians. The cases from the interface matched with the ones identified through manual review. The interface was interactive, that is, users had the ability to filter cases based on various entities such as case type, country, date range, indication, and trade name. Also, the output can be exported to widely acceptable formats (e.g., as a PDF or to a Microsoft Excel file).

Conclusion

The interface was able to successfully identify and extract SPM cases based on the selection criteria provided. The framework is scalable, as evidenced by the fact that the interface successfully extracted SPM cases for several medications. This interface has reduced the timeline of providing the SPM output from 3 months to 45 minutes. This tool has also strengthened our clinical and safety practices through process optimization