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  1. Oncology Center of Excellence

Oncology Real World Evidence Program

Fostering Regulatory Science and Collaboration to Translate Real World Data into Real World Evidence

RWE 2022 Graphic Element


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 Research & Collaboration
  • Regulatory Policy
  • Education & Engagement

Oncology RWE Program Leaders


Donna R. Rivera, PharmD, MSc, is Associate Director of Pharmacoepidemiology in the OCE and leads the Oncology RWE Program. 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 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 creating OCE’s patient-focused drug development program, and expanding OCE’s efforts to advance RWE, decentralized trial designs, and digital health technology. 


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 Members 2022-2024

Donna Rivera, PharmD, MSc
Peter Bross, MD
Patrick DeMoss, MD
Jaleh Fallah, MD
Chaohong Fan, MD, PhD
Shabnam Ford, PhD
Michael Fusco, PharmD
Bernardo Goulart, MD
Vab Kumar, MD
Jennifer Lee, PharmD, RAC
Catherine Lerro, PhD
Gautam Mehta, MD
Pallavi Mishra-Kalyani, PhD
Abhilasha Nair, MD
Reena Philip, PhD
Elizabeth (Dianne) Pulte, MD
Fatima Rizvi, PharmD
Melanie Royce, MD, PhD
Deepti Telaraja, MD
Jonathon Vallejo, PhD
Joe Wynne, MD, PhD
Jay Zhao, PhD

Contact Information

Contact: OCERWE@fda.hhs.gov
Twitter: #OCERWE  #OCETeamFoRWD

Further Information


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