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CDER establishes new Center for Real-World Evidence Innovation

[12/12/2024] Today, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) announced the new CDER Center for Real-World Evidence Innovation (CCRI) which aims to coordinate, advance, and promote the use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making across CDER.

RWD relates to a patient’s health status and/or the delivery of health care routinely collected from a variety of sources (e.g., electronic health records, medical claims, product and disease registries, and cutting-edge technologies).  By using data from routine clinical practice, we can generate evidence (referred to as RWE) that provides valuable insights into the safety and effectiveness of medical products.

"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, M.D. "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."

The volume and complexity of data available to support drug development have increased substantially over the past several decades. This increase—combined with enhanced computing power, emerging technologies, and advances in epidemiological and statistical methods—are transforming how drugs are developed, manufactured, and utilized.  

The goal of CCRI will be to advance, coordinate, and promote consistency across RWD/RWE-related initiatives in CDER, including related uses of emerging technologies in both internal and external FDA activities. We envision CCRI as a collaborative core for innovation and a focal point to ensure CDER promotes consistency and transparency on topics related to RWD and RWE.

With the upcoming retirement of Dr. John Concato, who has successfully led the development of CDER’s RWE program for the past four years, we have launched a national search for a new leader of CCRI, who will be supported by a team of leaders and experts from offices already conducting activities under the CDER RWE Program. More information about CCRI will be forthcoming in the next few months.  

For more information as it becomes available, visit the CCRI webpage. 

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