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Value of Data Sharing to Advance Drug Development: A Regulatory Perspective
Aliza Thompson1, Ameeta Parekh2
1Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, MD, USA.
Therapeutic Innovation & Regulatory Science
|April 20, 2021
Summary
Developing new tools for medical product evaluation requires collaboration and data sharing. Patient-level data is key to advancing drug development innovation and improving safety predictions.
Area of Science:
- Regulatory Science
- Drug Development
- Biostatistics
Background:
- Effective tools are needed to evaluate and predict medical product efficacy and safety.
- Current drug development processes require enhanced collaboration and data sharing.
- Patient-level data holds significant potential for improving regulatory science.
Purpose of the Study:
- To discuss experiences using patient-level data in drug development.
- To highlight the importance of data sharing for innovation.
- To offer perspectives and suggestions for future efforts in regulatory science.
Main Methods:
- Review of experiences from the Critical Path Institute (C-Path).
- Analysis of patient-level data utilization.
- Perspective sharing on data sharing challenges and opportunities.
Main Results:
- Patient-level data facilitates innovation in drug development.
- Collaboration and data sharing are crucial for developing new evaluation tools.
- C-Path's experiences offer valuable insights.
Conclusions:
- Effective use of patient-level data can accelerate medical product development.
- Continued collaboration and data sharing are essential for regulatory science advancement.
- Future efforts should focus on optimizing data sharing practices.
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