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Adopting a Framework for Rapid Real-World Data Analyses in Safety Signal Assessment.

Lu Wang¹, Negar Golchin², Stephanie von Klot³

¹Janssen Research and Development LLC, The Pharmaceutical Companies of Johnson & Johnson, 200 Tournament Drive, Horsham, PA, 19044, USA.

Therapeutic Innovation & Regulatory Science

|September 6, 2024

Summary

Real-world data (RWD) offers valuable safety insights but requires efficient analysis. A new framework helps safety teams rapidly deliver RWD evidence within regulatory timelines.

Keywords:

Minimal protocol Pharmacovigilance Rapid data analysis Real-world data (RWD)Safety signal assessment Transcelerate

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Area of Science:

Pharmacovigilance and Drug Safety
Real-World Data Analytics
Regulatory Science

Background:

Real-world data (RWD) is increasingly utilized for postmarketing safety surveillance and signal management.
Challenges exist in the timely preparation, execution, and communication of RWD analyses for safety assessments.
Regulatory timelines necessitate rapid, well-designed RWD analysis results.

Purpose of the Study:

To present a framework developed by TransCelerate BioPharma to expedite RWD analyses for safety signal assessment.
To illustrate the practical application of this framework using a prior safety assessment.

Main Methods:

A TransCelerate BioPharma working group developed a framework for RWD analysis in safety signal assessment.
A retrospective evaluation of a previous safety assessment was conducted using the developed framework.

Main Results:

The framework aims to streamline the process of analyzing RWD for safety signal assessment.
The evaluation demonstrated the framework's potential to facilitate rapid delivery of safety evidence.

Conclusions:

The developed framework can assist safety teams in overcoming challenges associated with rapid RWD analysis.
Adoption of the framework can support timely and reliable evidence generation for regulatory submissions.