CCTST Contributes to National Workshop on Real-World Data and Real-World Evidence

Stanford School of Medicine, National Center for Advancing Translational Sciences (NCATS), and the CTSA Coordination, Communication, and Operations Support (CCOS), recently hosted a collaborative workshop on real-world data (RWD) and real-world evidence (RWE) in Washington, DC.

The multidisciplinary workshop brought together researchers, patients, industry, and government leaders to advance the future of RWD/RWE research. Discussions emphasized transparency, adaptability, and reproducibility in data-driven research; the importance of governance, interoperability, metadata standards, and data quality; meaningful patient and community engagement throughout the research lifecycle; and workforce development, team science, mentorship, and sustainable collaborative research models.

The CCTST was represented by Monica Banks, a member of the CCTST Cincinnati Children’s Research Participant Advisory Council (RPAC); Takunda Matose, PhD, CCTST Ethics, Regulatory Knowledge, and Support program; and Nick Ollberding, PhD, co-lead for CCTST Resources and Services.

Both Monica and Dr. Matose served on the panel discussion titled “Governance Models for Sustainable and Trustworthy RWD”.

Dr. Matose highlighted the need for researchers, institutions, and real-world data platforms to engage in ways that earn and maintain public trust. Dr. Matose and panelists also discussed the notion of creating real-world data platforms that function as public utilities and thinking about what that might mean in terms of accessibility, benefit, and protection.

Monica Banks, CCHMC RPAC Member

Monica Banks shared her perspective as a parent advocate. Her advocacy journey began when her daughter, Isabel, was diagnosed with lupus at age nine. During Isabel’s treatment, she was supported by a dedicated team of physicians who were deeply involved in research. Throughout the process, Isabel accepted her diagnosis and decided that she wanted to be part of a long-lasting solution, which included research. Over the years, she has participated in numerous research studies, including clinical drug trials. As a pediatric patient, Monica was along for the journey. Today, Isabel is entering her sophomore year at the University of Cincinnati and is pursuing a path toward becoming a pediatric rheumatologist. She remains involved in research and is currently participating in the Cincinnati Children's SURF program!

Monica emphasized the importance of incorporating the patient perspective throughout the entire research process - from study conception and design to communicating findings back to the patients who contributed their data. Some of the key points she made:

• Families are often the continuity layer in a fragmented healthcare system. We carry timelines, symptoms, treatment responses, records, and outcomes across institutions and over years.

• Families are willing to share incredibly personal data when they believe the system is stewarding it responsibly, transparently, and ethically.

• Good governance is not just about protecting data. It’s about honoring the people behind it.

• In pediatrics, governance is uniquely complex because children eventually become adults. We need systems that respect both parental stewardship and the future autonomy of the patient.

• Families stay engaged when they feel respected, informed, included, and connected to outcomes over time.

• Reproducibility improves when participation burden is reduced. Otherwise, research will continue to overrepresent families with the time, resources, and stability to participate.

• The future of trustworthy real-world evidence depends not only on better technology, but on stronger partnerships with the families living these experiences every day.