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Leveraging real-world data in safety signal assessment: a survey of biopharmaceutical companies
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  • Vaishali Patadia,
  • Katrin Manlik,
  • Geoff Gipson,
  • Jenna C. Willis,
  • Ruth Namuyinga,
  • Rachel McDermott,
  • Anita Shaw,
  • Mary K. Miller,
  • Julius Asubonteng,
  • Negar Golchin,
  • Stephanie von Klot
Vaishali Patadia
Amgen Inc

Corresponding Author:[email protected]

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Katrin Manlik
Bayer AG
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Geoff Gipson
Janssen Research and Development Horsham
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Jenna C. Willis
Roche UK Ltd
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Ruth Namuyinga
Janssen Research and Development Horsham
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Rachel McDermott
Shionogi Inc
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Anita Shaw
Merck & Co Inc - Rahway
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Mary K. Miller
Genentech Inc
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Julius Asubonteng
Regeneron Pharmaceuticals Inc
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Negar Golchin
Bristol Myers Squibb Co
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Stephanie von Klot
Boehringer Ingelheim International GmbH
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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.
12 May 2023Submitted to Pharmacoepidemiology and Drug Safety
12 May 2023Assigned to Editor
12 May 2023Submission Checks Completed
12 May 2023Review(s) Completed, Editorial Evaluation Pending
03 Jun 2023Reviewer(s) Assigned
12 Aug 2023Editorial Decision: Revise Major
31 Oct 20231st Revision Received
31 Oct 2023Assigned to Editor
31 Oct 2023Submission Checks Completed
31 Oct 2023Review(s) Completed, Editorial Evaluation Pending