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  6. CDER Center for Real-World Evidence Innovation (CCRI) Frequently Asked Questions
  1. CDER Center for Real-World Evidence Innovation (CCRI)

CDER Center for Real-World Evidence Innovation (CCRI) Frequently Asked Questions

What is CCRI?

CCRI stands for CDER Center for Real-World Evidence Innovation. We expect CCRI to serve as a focal point for innovation and to ensure that CDER is speaking with a unified and consistent voice on topics related to real-world data (RWD) and real-world evidence (RWE).

What is the scope of CCRI activities?

The scope of CCRI will be aligned with the 21st Century Cures Act of 2016 to evaluate the use of RWE for supporting a new indication for an already approved drug or biological product or satisfying post-approval study requirements; relevant technology-based innovations to further those goals (such as artificial intelligence and digital health tools) will also be addressed. Serving in a problem-solving capacity where needed, CCRI will work specifically to address any regulatory and scientific barriers that could limit the appropriate use of RWE in CDER decision-making regarding effectiveness. CCRI will be integrated with ongoing RWE-based activities but will not replace them.

Why establish the CCRI now?

The volume and complexity of regulatory and policy issues related to real-world data (RWD) available to support drug development have increased substantially in recent years. This growth, combined with enhanced computing power and emerging technologies, are transforming how drugs are developed, manufactured, and utilized. FDA’s RWE Program for CDER involves multiple components: guidance development to assist developers interested in using RWD to develop RWE and support Agency decisions; internal processes to promote consistent evaluation of RWE and to promote shared learning ; demonstration (research) projects with a focus on evaluating/improving data quality and use of RWD, advancing study design, and developing rigorous evaluation tools; and external engagement including “listening sessions,” presentations, and publications.

FDA has also published guidance documents and/or discussion papers on digital health technologies and the use of artificial intelligence (AI). In addition, the seventh iteration of the Prescription Drug User Fees Act included new RWE-related provisions, such as requiring new RWE public reporting and establishing the Advancing RWE Program that enables “early” discussions with sponsors regarding RWE-based study proposals. Given the increasing use of RWD, a centralized structure in CDER can inform operations and strategic planning, outreach and engagement, research initiatives, and knowledge management.

Who are the participants and key interested parties of the CCRI?

CDER will continue to collaborate across existing offices and engage staff (e.g., clinicians, statisticians, epidemiologists, regulatory specialists) who conduct reviews, manage submissions, or develop guidance for RWD/RWE. The Office of Medical Policy will retain a central role in coordinating CDER RWE activities, while sharing responsibilities with other offices. Also, CCRI will coordinate engagements with other Centers and external parties on behalf of CDER. External parties continue to play an important role in understanding the full potential for RWD/E and leveraging the use of emerging technologies in drug development.

What activities will be some of the CCRI focus areas?

Initial focus activities for CCRI includes 1) scientific review and policy to include guidance and policy development; 2) coordinated outreach and engagement (e.g., workshops, meetings with external interested parties); 3) support of regulatory science; and 4) knowledge management (e.g., centralized repository, internal training). 

How does this new CCRI differ from the existing FDA RWE Program?

CDER leadership envisions CCRI as allowing for more efficient and consistent communication across CDER offices and with CDER leadership. CCRI can also increase coordination of RWE-related activities among offices involved with CCRI.

How will CDER staff be affected?

There is no expectation of increased workload other than for CCRI staff. CCRI will, however, offer new opportunities for collaboration on RWE-related projects and enhance understanding of CDER’s approach to RWD/RWE through training and communication.

How will CCRI impact regulatory review?

As a central core for RWE, CCRI will a) advance appropriate use of RWE within CDER to inform the effectiveness and safety of medical products, and b) promote inter-office collaboration and consistent approaches to RWD/RWE.

How will CCRI benefit public health?

CCRI is committed to supporting engagements with CDER and interested parties and will coordinate relevant activities and policies involving RWD and RWE. An early charge for CCRI will be to develop and implement a strategic plan for the RWE Program going forward, now that a first-generation series of guidance documents have been published and meeting PDUFA commitments is on track. Supporting the appropriate use of RWE will also lead to improvements in public health outcomes.

How does CCRI fit in with other CDER initiatives like C3TI?

The CDER Center for Clinical Trial Innovation (C3TI) supports innovative approaches for conducting clinical trials that are designed to improve the efficiency of drug development. CCRI serves a parallel purpose in aiming to support existing CDER programs for other types of study design and spur RWE-related innovative activities through enhanced communication and collaboration.

How can sponsors and interested external parties engage with CCRI?

Existing structures and processes will be linked to CCRI. Aligned with current recommendations, CDER encourages interested parties who are considering the use of RWE to engage the agency early.

  • Sponsors of applications should contact their therapeutic review division and request that a representative from the RWE team participate in the discussion.  
  • Sponsors or other interested parties who are considering the use of RWE not associated with a specific drug application (e.g., would like to discuss general feasibility of the RWD or have general questions for the RWE Program) can send an email inquiry to cder-rwe@fda.hhs.gov.
  • Sponsors interested in learning more about the PDUFA VII Advancing RWE Program should visit the website for more information.
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