Oncology Quality, Characterization, and Assessment of Real-World Data (QCARD) Initiative: An FDA and Reagan-Udall Foundation Collaboration

OBJECTIVES: The FDA is evaluating methods to advance appropriate uses of real-world data (RWD) to generate real-world evidence for regulatory decision-making. A sustained regulatory science research effort is necessary to advance knowledge given the increasing volume of RWD submissions for regulatory review, particularly in oncology medical product development. Early proposals for studies including RWD often lack fundamental elements of the study design and data characterization necessary to facilitate feedback. A collaboration with the Reagan-Udall Foundation was established to develop standard key data elements for characterization of a RWD study with the goal of increasing review efficiency and facilitating effective communication.

METHODS: The Oncology Quality, Characterization, and Assessment of Real-World Data (QCARD) Initiative has three aims: a) review published literature, guidelines, and guidances on RWD dimensions of quality measurement, b) engage scientific experts and obtain feedback on essential RWD study design elements and data characteristics, and c) generate a template of key study and data elements necessary to facilitate early review of studies incorporating RWD. The collaborative multidisciplinary (epidemiology, clinical oncology, biostatistics, and health services research) expert committee drafted an initial template and complementary conceptual model.

RESULTS: The Oncology QCARD includes minimum data and design elements that sponsors can include with their initial regulatory submissions to facilitate clear understanding and efficient evaluation of a proposed study. Domains included high-level characteristics of RWD source and study design parameters including temporality, population, medical product exposure, comparators, covariates, endpoints, statistical analysis, and data quality assurance plans.

CONCLUSIONS: Evaluation of studies including RWD requires understanding the data source, study design, and potential biases to preliminarily evaluate whether selected RWD are fit-for-use for the research question. The Oncology QCARD provides a structured, transparent approach to facilitate early review and enhanced communication between study sponsors and scientific reviewers of initial RWD study proposals.