Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment

Autor: Frank W. Rockhold, Richard C. Zink, Yixin Fang, JC Chen, Pallavi Mishra-Kalyani, Weili He, Martin Ho, Douglas E. Faries, Kwan Lee, Benjamin A. Goldstein, Hong-Wei Wang, Mark Levenson
Rok vydání: 2021
Předmět:
Zdroj: Statistics in Biopharmaceutical Research. 15:3-13
ISSN: 1946-6315
Popis: Real-world evidence (RWE), derived from data from “real-world” clinical practice and medical product utilization, is an increasingly important source of evidence that holds great potential to incre...
Databáze: OpenAIRE