Leveraging real-world data in safety signal assessment: a survey of
biopharmaceutical companies
Abstract
Purpose TransCelerate BioPharma conducted a survey of
biopharmaceutical companies to evaluate current practice and identify
opportunities to complement safety signal assessment with rapid
real-world data (RWD) analysis. Methods A voluntary 30-question
survey regarding 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 participated in the
survey. 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-routinely or in a pilot setting, 2 (11%) are
considering using rapid RWD analysis, and 1 (6%) has no plans to use
rapid RWD analysis for their signal assessment. Most companies reported
that RWD adds context to and improves quality of signal assessments. To
conduct RWD analysis for signal assessment, 16 of 17 (94%) respondent
companies utilize or plan to utilize internally available data, 8 (47%)
utilize both internal and external data, and 3 (18%) utilize data
networks. Respondents identified key challenges to rapidly performing
RWD analyses, including data access/availability, time for analysis
execution, and uncertainties regarding acceptance of minimal or
non-protocolized approaches by health authorities. Conclusion
Biopharmaceutical companies reported that they see value in the use of
rapid RWD analyses for complementing signal assessments. Future work is
recommended to offer a framework and process for use of rapid use of RWD
analyses in signal assessment.