FDA's new Center for Real-World Evidence Innovation to unlock potential of RWD and RWE

The US Food and Drug Administration (FDA)’s CDER has launched the CDER Center for Real-World Evidence Innovation (CCRI) to enhance regulatory use of real-world data (RWD) and evidence (RWE).

The FDAs Center for Drug Evaluation and Research (CDER) has announced the creation of the CCRI to advance the use of RWD and RWE in regulatory decision-making. The move reflects the growing interest in RWE worldwide and CDER’s commitment to leveraging innovative data sources and methodologies to improve drug development processes.

Speaking at yesterday’s workshop ‘Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products—Looking Forward’ coordinated by the Duke-Margolis Institute for Health Policy, Jacqueline Corrigan-Curay (FDA) shared further details about the initiative. She noted that the CCRI’s vision is to “optimize the use of real-world data to inform the effectiveness and safety of drugs and biological products.” This includes developing a strategic plan that builds on the FDA’s 2018 framework to define new priorities for research, policy, and guidance.

CCRI’s scope aligns with the goals of the 21st Century Cures Act of 2016 and also complements other FDA RWE activities. The new CCRI will differ from the existing FDA RWE Program by enabling more streamlined communication across CDER offices and with CDER leadership, as well as enhancing coordination of RWE-related activities among the participating offices.

The center will focus on four main areas:

1. Scientific review and policy, including guidance and policy development
2. Coordinated outreach and engagement through workshops and meetings with external interested parties
3. Regulatory science initiatives, including a research portfolio to support evidence generation and innovation, as well as dissemination of findings to inform regulatory practices and external stakeholders
4. Knowledge management via a centralized repository and internal training

The CCRI’s establishment comes as the volume and complexity of available data for drug development have grown significantly. Advances in computing power, statistical methods, and emerging technologies have transformed how treatments are developed, manufactured, and evaluated. To capitalize on these developments, CCRI will coordinate RWD and RWE-related initiatives across CDER, promoting consistency in their application and transparency in regulatory 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,” the announcement noted. The center will also explore ways to incorporate emerging technologies to further advance the field.

The center's initial priority will be to develop and implement a strategic plan for the RWE Program, building on the publication of the first-generation guidance documents and the progress made in meeting PDUFA commitments.

The announcement follows the upcoming retirement of Dr. John Concato, who has led CDER’s RWE program for the past four years. Under his leadership, significant progress has been made in integrating RWE into regulatory processes. A national search is underway to appoint a new leader for CCRI, who will work alongside experts from existing RWE-related programs within CDER.