Real-world evidence can provide additional information about how medical products are used and how outcomes are observed outside traditional controlled clinical trial settings. Depending on the development program, real-world data may complement evidence generated through clinical research.
Why It Matters
Clinical development programs may require information from multiple sources to address research questions across different stages of development. Real-world evidence can provide additional context when appropriately designed and analyzed.
Key Points
- Identify the research question before selecting data sources.
- Evaluate the suitability and quality of available data.
- Define appropriate study populations and outcomes.
- Consider data management and analytical requirements.
- Establish appropriate methods for interpreting findings.
What Sponsors Should Consider
Sponsors should evaluate whether available real-world data are suitable for the intended research question. Factors such as data completeness, population characteristics, study design and analytical methodology may need to be considered.
How CEBIS Can Support
CEBIS can provide support for research activities involving clinical development, observational research, data management and related areas, depending on the specific requirements of the program.
Sources / References
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