FDA Creates CDER Center for Real-World Evidence Innovation

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FDA announced on Dec. 12, 2024 that the Center for Drug Evaluation and Research (CDER) has created a Center for Real-World Evidence Innovation (CCRI). The CCRI will coordinate, advance, and promote the use of real-world data (RWD) and real-world evidence (RWE) when making regulatory decisions at CDER (1).

Patient health data from sources such as electronic health records, medical claims, and product and disease registries are considered RWD. Real-world evidence can be generated from this RWD to provide insight into the effectiveness of drugs. According to FDA, patient data has increased in volume and complexity during the past few decades, this data has transformed the way drugs are developed, manufactured, and used. The CCRI will advocate, coordinate, and promote these data within CDER including initiatives related to emerging technologies.

"CDER’s new Center for Real-World Evidence Innovation represents a major step forward in our efforts to unlock the full potential of RWD to inform clinical and regulatory decisions," said CDER Director Patrizia Cavazzoni, MD (2). "We are creating a focal point within CDER to identify ways in which we can utilize RWE to streamline the development of effective and safe medicines for conditions with unmet need."

In 2023, FDA published its guidance on RWD,Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products,on how to design a registry or use an existing registry to support regulatory decision-making about the safety and effectiveness of a drug (3). The guidance includes information about a registry’s fitness-for-use, linking a registry to other data sources for supplemental information, and supporting FDA review of submissions.

The guidance defines a registry “as an organized system that collects clinical and other data in a standardized format for a population defined by a particular disease, condition, or drug exposure.” Real-word data are defined in the guidance document as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.” RWE is defined by FDA as “the clinical evidence about the usage and the potential benefits or risks of a medical product derived from analysis of RWD” (3).

FDA isn’t the only regulatory body utilizing RWD in decision making. In Europe, the European Medicines Agency (EMA) promotes using RWD as part of its Regulatory Science Strategy of 2025 (4). The agency plans on creating a framework to delivery and analyze RWD during a product’s lifecycle. It will then implement processes to use these data in regulatory assessments. EMA also published RWD catalogues in March 2024 to help regulators, pharma companies, and researchers to use RWD for determining the safety and effectiveness of drugs. And in April 2024, EMA released guidance on the types of studies that can be used to perform RWE generation (4).

References

1. FDA. CDER Center for Real-World Evidence Innovation (CCRI). FDA.gov (accessed Dec. 13, 2024).https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-center-real-world-evidence-innovation-ccri
2. FDA. CDER Establishes New Center for Real-World Evidence Innovation. FDA.gov (accessed Dec. 13, 2024). https://www.fda.gov/drugs/drug-safety-and-availability/cder-establishes-new-center-real-world-evidence-innovation
3. FDA. Guidance for Industry, Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products (CDER, CBER, December 2023).
4. Barton, C. Using RWD in Non-Interventional Studies. Pharmaceutical Technology Europe. 2024, 36 (6).