The Oncology QCARD Initiative: Fostering efficient evaluation of initial real-world data proposals

Area of Science:

• Oncology
• Real-World Data (RWD) Analysis
• Health Informatics

Background:

• The Oncology Quality, Characterization, and Assessment of Real-World Data (QCARD) Initiative addresses the need for robust evaluation of real-world data (RWD) in oncology research.
• Ensuring the quality and suitability of RWD sources is critical for reliable clinical study concepts and decision-making.

Purpose of the Study:

• To develop minimum study design and data elements for evaluating the fitness of RWD sources.
• To facilitate early interaction between study sponsors and scientific reviewers regarding RWD study proposals.

Main Methods:

• A multidisciplinary executive committee guided the initiative.
• A landscape review of literature, guidances, and guidelines was conducted to identify data quality dimensions.
• Expert feedback informed the development of the Oncology QCARD Initial Protocol Characterization (IPC).

Main Results:

• Fit-for-use data (relevant and reliable) and fit-for-purpose design (ensuring validity and transparency) emerged as key themes.
• The QCARD-IPC outlines essential elements for describing RWD study concepts, covering data temporality, populations, exposures, comparators, covariates, endpoints, and quality assurance.

Conclusions:

• Evaluating RWD studies necessitates understanding data sources, design, and potential biases to determine fitness-for-use.
• The Oncology QCARD-IPC offers a structured, transparent approach for preliminary review and improved communication on RWD study proposals.