Open AccessRegulatory-grade clinical trial design using real-world data
Author(s) -
Mark Levenson
Publication year - 2020
Publication title -
clinical trials
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.559
H-Index - 63
eISSN - 1740-7753
pISSN - 1740-7745
DOI - 10.1177/1740774520905576
Subject(s) - real world data , risk analysis (engineering) , transparency (behavior) , food and drug administration , regulatory science , real world evidence , computer science , data quality , clinical trial , robustness (evolution) , clinical study design , data science , medicine , business , computer security , marketing , metric (unit) , biochemistry , chemistry , pathology , gene
Real-world data and evidence provide the potential to address the effectiveness and safety of drugs. The U.S. Food & Drug Administration has initiated a program to evaluate the potential use of real-world evidence for regulatory uses. Whether a study is designed for regulatory purposes or for other purposes, existing regulation and guidance provide a reference for high-quality studies. Clarifying the study objectives and the role of real-world data in the study are important considerations. Robustness and transparency of the analysis allow for greater understanding and acceptance of the study results.