FDA defines real-world data (RWD) as data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources and real-world evidence (RWE) as the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD.¹ [Framework]

In alignment with the 21st Century Cures Act, the goal of the Oncology Center of Excellence Real World Evidence Program is to engage in evidence development modernization through scientific collaboration and policy development to advance the appropriate fit-for-purpose application of RWD to generate RWE for regulatory purposes. Using a systematic approach to regulatory science, the OCE RWE program focuses on evolving scientific knowledge and rigorous methodological use of RWD to advance the development of oncology products in the pre- and post-approval settings.  

RWE Mission Statement

Collaboratively advance the appropriate use of real-world evidence in oncology product development to facilitate patient-centered regulatory decision-making. 

OCE RWE Strategic Priorities 

• Optimize knowledge building through a centralized oncology RWD research portfolio that ensures study efficiency, transparency, and diversity.
• Advance the scientific development of resources, regulatory policy, and guidance on appropriate use of RWD informed by methodological research and collaboration.
• Collaborate through strategic partnerships that foster pragmatic, appropriate use of RWD across FDA, federal agencies and through public private partnerships.
• Accelerate the field of Oncology RWE through leadership and training in rigorous evaluation, methods development, and regulatory science.

Focus Areas

• Regulatory Review
• Regulatory Science & Collaboration
• Regulatory Policy
• Education & Engagement

Meet Team FoRWD

To advance the regulatory use of RWE, we have assembled TEAM FoRWD (Translational Evaluation and Assessment of Methods to Facilitate use of Oncology RWD). 

TEAM FoRWD comprises FDA scientists with expertise in pharmacoepidemiology, hematology and oncology, epidemiology, biostatistics, and regulatory science to evaluate opportunities for RWD in regulatory contexts that can complement our understanding of medication risks and benefits for patients.

Team FoRWD Leaders

Donna R. Rivera, PharmD., MSc., is the Associate Director of Pharmacoepidemiology in the Oncology Center of Excellence at the US Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the use of Real World Data (RWD) and RWE for regulatory purposes as well as management of the RWD research portfolio strategy and development of related regulatory policy to support the OCE mission. As a pharmacist and pharmacoepidemiologist, Dr. Rivera has interests in the use of RWD to increase knowledge of unrepresented populations and advance health equity, observational study designs and RWD methodological approaches, and appropriate uses of RWD for drug development to increase access of effective therapies to patients.

Paul G. Kluetz, MD, is a medical oncologist and the Deputy Director of the Oncology Center of Excellence at the U.S. FDA.  In addition to assisting in the strategic and operational oversight of the OCE, he has a broad interest in trial design and endpoint selection to expedite drug development and define clinical benefit in oncology trials. Some of his initiatives include creation of the OCE’s patient-focused drug development program and expansion and support of OCE’s efforts to advance real-world evidence, decentralized trial designs and digital health technology. 

Select External Research Collaborations

• Friends of Cancer Research Patient Reported Outcomes Collaborative (in collaboration with OCE PFDD Team)
• FDA and Project Datasphere PPP to Accelerate Oncology Clinical Research
• LUNGevity: Understanding the lung cancer Patient Experience in the Real-world setting and comparing it to the regulatory setting
• Apple: Design and validation of development tools using Digital Symptom  Reporting (in collaboration with OCE PFDD Team)
• COTA: A Master Protocol for Understanding the Applications of Real-World Evidence in Oncology
• Flatiron: Real World Clinical Characteristics and Treatment of Patients with Cancer
• Syapse: Real-world clinical characteristics to inform regulatory considerations in oncology
• National Cancer Institute: Collaboration with Apple to Advance the Use of Digital Health Technologies for Patient Reported Outcome Measures

Contact: [email protected]
Twitter: #OCERWE  #OCETeamFoRWD

Further Information

• FDA Office of Medical Policy (OMP) 
• FDA Center for Devices and Radiological Health
• OCE Scientific Collaborative Priorities