Leveraging Real-World Data in Safety Signal Assessment.

ABSTRACT:

Purpose

TransCelerate BioPharma surveyed its member biopharmaceutical companies to understand current practices and identify opportunities to complement safety signal assessment with rapid real-world data (RWD) analysis.

Methods

A voluntary 30-question questionnaire regarding the use of RWD in safety signal assessment was disseminated to subject matter experts at all TransCelerate member companies in July 2022. Responses were blinded, aggregated, summarized, and presented.

Results

Eighteen of 20 member companies provided responses to the questionnaire. Sixteen (89%) companies reported actively leveraging RWD in their signal assessment processes. Of 18 respondent companies, 8 (44%) routinely use rapid approaches to RWD analysis, 7 (39%) utilize rapid RWD analysis non-r

SUBMITTER: Patadia V 

PROVIDER: S-EPMC11530550 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature