USFDA: CDER Establishes New Center for Real-World Evidence Innovation (CCRI)

The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has unveiled an innovative initiative—the CDER Center for Real-World Evidence Innovation (CCRI). This new center is poised to enhance the use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making processes, marking a significant milestone in modern drug evaluation and development.

• Real-World Data (RWD): Refers to health-related data routinely collected from diverse sources, such as:

  • Electronic health records (EHRs)

  • Medical claims databases

  • Product and disease registries

  • Wearable technologies and other advanced tools

• Real-World Evidence (RWE): Evidence derived from the analysis of RWD, used to evaluate the safety, effectiveness, and broader impact of medical products in real-world settings.

The explosion of healthcare data—fueled by technological advancements, computing power, and statistical methods—has transformed drug development, manufacturing, and utilization. The CCRI was established to address this paradigm shift and to ensure the FDA stays at the forefront of innovation in drug evaluation.

Goals of the CCRI:

1. Promote Consistency: Ensure uniformity across CDER’s RWD/RWE-related initiatives.

2. Enhance Collaboration: Act as a hub for internal and external collaboration on RWD/RWE projects.

3. Advance Innovation: Leverage emerging technologies and advanced methods in data analytics to improve regulatory decision-making.

4. Increase Transparency: Foster public trust by promoting clarity on RWD and RWE applications in drug regulation.

The CCRI is expected to revolutionize the FDA’s regulatory processes by:

• Incorporating RWE into Decision-Making: Providing more robust, real-world insights into drug safety and efficacy.

• Streamlining Drug Development: Enabling faster, more cost-effective development processes by utilizing RWD in place of or alongside traditional trials.

• Supporting Personalized Medicine: Enhancing understanding how drugs perform across different patient populations.

The establishment of the CCRI marks a forward-looking approach to modern drug regulation, ensuring that CDER remains adaptive to technological advancements and evolving healthcare landscapes. More details about the CCRI’s framework and initiatives will be revealed in the coming months.

For updates, visit the CCRI webpage.