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

Lin, Li-An; Zhang, Yafei; Straus, Walter; Wang, William.

Affiliation

Lin LA; Clinical Safety Statistics, Merck & Co., Inc, Kenilworth, NJ, USA. leeang.ling@gmail.com.
Zhang Y; Clinical Safety Statistics, Merck & Co., Inc, Kenilworth, NJ, USA.
Straus W; Clinical Safety, Moderna, Cambridge, MA, USA.
Wang W; Clinical Safety Statistics, Merck & Co., Inc, Kenilworth, NJ, USA.

Ther Innov Regul Sci ; 56(3): 423-432, 2022 05.

Article in En | MEDLINE | ID: mdl-35138577

Subject(s)

Hypoglycemic Agents; Research Design; Humans; Marketing

Key words

Cardiovascular outcome trial; Causal inference; Observational study; Randomized clinical trial; Real-world data; Type 2 diabetes mellitus

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Research Design / Hypoglycemic Agents Type of study: Clinical_trials / Observational_studies / Prognostic_studies Limits: Humans Language: En Journal: Ther Innov Regul Sci Year: 2022 Type: Article Affiliation country: United States

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