Integrative Analysis of Randomized Clinical Trial and Observational Study Data to Inform Post-marketing Safety Decision-Making - Lin, Li-An; Zhang, Yafei; Straus, Walter; Wang, William (Therapeutic innovation & regulatory science, 2022)
Keywords: Analytical Report; Antidiabetics; Cardiovascular diseases; Clinical trials; Data integration; Decision making; Diabetes mellitus; Drug development; Drug Safety and Pharmacovigilance; Feasibility studies; Health risks; Life cycles; Marketing; Medicine; Observational studies; Pharmacotherapy; Pharmacy; Population studies; Product safety; Safety; Sensitivity analysis; Statistical analysis; Causal inference; Observational study; Randomized clinical trial; Type 2 diabetes mellitus; Cardiovascular outcome trial; Real-world data