Data from U.S. Food and Drug Administration (FDA) Provide New Insights into Clinical Trial Research (The Oncology Qcard Initiative: Fostering Efficient Evaluation of Initial Real-world Data Proposals).

The article discusses the Oncology QCARD Initiative, which aims to establish minimum study design and data elements for evaluating real-world data sources in clinical trial research. The initiative focuses on ensuring data fitness for use and purpose, transparency in study design, and early communication between study sponsors and scientific reviewers. Financial support for this research came from the U.S. Food and Drug Administration. The research provides a structured approach to enhance the evaluation of initial study proposals involving real-world data. [Extracted from the article]