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Leveraging Real-World Data in Safety Signal Assessment
Vaishali Patadia1, Katrin Manlik2, Geoffrey Gipson3
1Amgen, One Amgen Center Drive, Thousand Oaks, CA, 91320, USA. vpatadia@amgen.com.
Biopharmaceutical companies increasingly use real-world data (RWD) for safety signal assessment. While valuable, challenges in data access and regulatory acceptance need addressing for broader adoption of rapid RWD analysis.
Area of Science:
- Pharmacovigilance and Drug Safety
- Real-World Data Analytics
- Biopharmaceutical Industry Practices
Background:
- Safety signal assessment is critical in drug development.
- Real-world data (RWD) offers a valuable complement to traditional methods.
Purpose of the Study:
- To survey biopharmaceutical companies on their use of RWD for safety signal assessment.
- To identify opportunities for integrating rapid RWD analysis into safety workflows.
Main Methods:
- A voluntary 30-question survey was distributed to TransCelerate member companies.
- Responses from subject matter experts were collected, blinded, and aggregated.
Main Results:
- 16 out of 18 (89%) companies actively use RWD for signal assessment.
- 44% routinely use rapid RWD analysis; key challenges include data access and regulatory acceptance.
- RWD is perceived to enhance the context and quality of safety signal assessments.
Conclusions:
- Biopharmaceutical companies recognize the value of rapid RWD analysis in safety signal assessment.
- Further development of frameworks and processes is recommended to support the use of rapid RWD analysis.
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