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Welcome to the March issue of RF Quarterly, which takes a look at patient-focused regulatory practice and includes articles on patient-reported outcomes in regulatory decision making; real-world evidence and postmarket surveillance data; generating evidence for racial and ethnic minorities in oncologic drug development; structured, patient-focused benefit-risk assessment; and the role of the high-performance integrated virtual in research using patient-generated data.
1 Introduction Flora Sandra Siami, MPH • Stephen C. Weber, MD HTML 4 The evolution and use of patient-reported outcomes in regulatory decision making Stephen C. Weber, MD HTML 11 Real-world evidence and postmarket surveillance data: Are they the same thing? Kasey Sands, PhD, MSN, RN • Joy Frestedt, PhD, CPI, RAC, FRAPS, FACRP HTML 23 Generating evidence for racial and ethnic minorities during development of oncologic therapeutics Lola Fashoyin-Aje, MD, MPH • Lea Ann Browning-McNee, MS • Jessica Boehmer, MBA • Richard Pazdur, MD • Susan C. Winckler, RPh, Esq HTML 31 Industry implementation of structured, patient-focused benefit-risk assessment Charles Garrigan, MS, MBA • Bennett Levitan, MD, PhD HTML 43 Enhancing collaboration, access, and research using patient-generated data Laura E. Gressler, MS, PhD • Art Sedrakyan, MD, PhD HTML
To contribute, email Renee Matthews, Senior Editor, at rmatthews@raps.org.
For more information, see: Guidelines for Authors • 2023 Editorial Calendar
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