A Framework to Support the Standardized Management of Real-World Data

Area of Science:

• Biomedical Informatics
• Clinical Research Informatics
• Data Science in Oncology

Background:

• Clinical and biological data from hematological malignancies present challenges for research.
• Existing data management systems require enhancement for multi-center studies.
• Real-world data (RWD) is crucial but often unstructured for evidence generation.

Purpose of the Study:

• To design a framework for standardized collection and transformation of RWD.
• To convert clinically relevant RWD into actionable evidence.
• To facilitate basic and clinical research in hematological malignancies.

Main Methods:

• Leveraging experience in data registration and management systems.
• Developing strategies for data collection and analysis in multi-center studies.
• Implementing a framework for standardized RWD transformation.

Main Results:

• A novel framework for RWD processing has been established.
• Standardized data collection protocols were defined.
• The framework facilitates the transformation of RWD into research-ready evidence.

Conclusions:

• The designed framework addresses challenges in RWD acquisition.
• Standardized RWD transformation promotes basic and clinical research.
• This approach enhances the utility of data from daily clinical practice.