FDA establishes new center to streamline new drug development using RWD/RWE

On 12 December, the US Food and Drug Administration (FDA) announced the creation of the Center for Drug Evaluation and Research (CDER) Center for Real-World Evidence Innovation (CCRI) to coordinate and promote the use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making.

The amount and complexity of data available to support drug development has significantly increased over the past few decades, according to FDA. This growth, along with improved computing power and advancements in epidemiological and statistical methods, is transforming the way drugs are developed, manufactured, and used.

The proportion of new drug and biologics approvals that included an RWE study increased from 75% (38 of 51 approvals) in 2019 to 90% (53 of 59 approvals) in 2021, and to 96% (25 of 26) in the first half of 2021, according to a study. published in Clinical Pharmacology and Therapeutics in November 2021.

FDA considers patient health data, such as that collected from patient registries and medical claims, as RWD, which facilitates the generation of RWE “that provides valuable insights into the safety and effectiveness of medical products,” according to the agency.

The new center “represents a major step forward in our efforts to unlock the full potential of RWD to inform clinical and regulatory decisions," CDER Director Patrizia Cavazzoni said in a statement. "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."

CCRI will focus on four activities: scientific review and policy, coordinated outreach and development, regulatory science initiatives, and knowledge management.

The scientific review and policy section will provide guidance, establish policies, and review RWD and RWE submissions. The coordinated outreach and engagement office will organize public meetings, while the regulatory science office will conduct research and share its findings. Additionally, the knowledge management branch will maintain a centralized repository of information related to RWD and RWE and conduct internal training sessions.

CDER is seeking a new leader for CCRI with the upcoming retirement of John Concato, who has “successfully led the development of CDER’s RWE program for the past four years,” according to the announcement.

Creation of CCRI aligns with other FDA efforts to boost the use and acceptance of RWD/RWE. In August 2023, the agency finalized a guidance on using RWD and RWE in supporting regulatory decisions for drugs and biologics, offering recommendations for data access and safety monitoring (RELATED: FDA finalizes guidance on real-world evidence in drug approvals, Regulatory Focus 31 August 2023).

FDA encourages sponsors who are considering the use of RWE to engage with the agency early. Sponsors should also contact their therapeutic review division and request that a representative from the RWE team participate in the discussion. Questions on using RWD can be sent to [email protected].

Announcement; Question-and-answer document

FDA establishes new center to streamline new drug development using RWD/RWE

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