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FDA-Catalyst-Using FDA's Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial.
Cocoros NM, Pokorney SD, Haynes K, Garcia C, Al-Khalidi HR, Al-Khatib SM, Archdeacon P, Goldsack JC, Harkins T, Lin ND, Martin D, McCall D, Nair V, Parlett L, Temple R, McMahill-Walraven C, Granger CB, Platt R. Cocoros NM, et al. Among authors: nair v. Clin Trials. 2019 Feb;16(1):90-97. doi: 10.1177/1740774518812776. Epub 2018 Nov 16. Clin Trials. 2019. PMID: 30445835
Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System.
Chrischilles EA, Gagne JJ, Fireman B, Nelson J, Toh S, Shoaibi A, Reichman ME, Wang S, Nguyen M, Zhang R, Izem R, Goulding MR, Southworth MR, Graham DJ, Fuller C, Katcoff H, Woodworth T, Rogers C, Saliga R, Lin ND, McMahill-Walraven CN, Nair VP, Haynes K, Carnahan RM. Chrischilles EA, et al. Pharmacoepidemiol Drug Saf. 2018 Mar;27(3):263-271. doi: 10.1002/pds.4375. Epub 2018 Jan 10. Pharmacoepidemiol Drug Saf. 2018. PMID: 29318683
Practical challenges in the conduct of pragmatic trials embedded in health plans: Lessons of IMPACT-AFib, an FDA-Catalyst trial.
Garcia CJ, Haynes K, Pokorney SD, Lin ND, McMahill-Walraven C, Nair V, Parlett L, Martin D, Al-Khalidi HR, McCall D, Granger CB, Platt R, Cocoros NM. Garcia CJ, et al. Among authors: nair v. Clin Trials. 2020 Aug;17(4):360-367. doi: 10.1177/1740774520928426. Epub 2020 Jun 26. Clin Trials. 2020. PMID: 32589056 Free PMC article.
1,732 results