When can real-world data generate real-world evidence?

Affiliations

• ¹ Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
• ² Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
• ³ Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
• ⁴ Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
• ⁵ Office of Regulatory Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
• ⁶ Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland, USA.
• ⁷ Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland, USA.
• ⁸ Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
• ⁹ Department of Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.