US FDA Introduces the Oncology QCARD Initiative

Although real-world data (RWD) is increasingly being used in oncology for clinical development, safety evaluation, and regulatory decision-making, the widely varying data sources make quality evaluation difficult. To address this issue, the US Food and Drug Administration (FDA) has announced the Oncology QCARD Initiative.

According to the Donna R. Rivera and Paul G. Kluetz, “The Oncology QCARD Initiative was designed to facilitate effective communication between study sponsors and protocol reviewers by evaluating the potential minimum elements for sponsors to consider when assembling submissions for review of a proposed study and RWD source(s). The Oncology QCARD Initiative was informed by input from an external group of epidemiology, biostatistics, clinical, and health services research experts.”

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(Source: FDA, June 27^th, 2023)