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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: archdeacon p. Clin Trials. 2019 Feb;16(1):90-97. doi: 10.1177/1740774518812776. Epub 2018 Nov 16. Clin Trials. 2019. PMID: 30445835
Electronic clinical laboratory test results data tables: lessons from Mini-Sentinel.
Raebel MA, Haynes K, Woodworth TS, Saylor G, Cavagnaro E, Coughlin KO, Curtis LH, Weiner MG, Archdeacon P, Brown JS. Raebel MA, et al. Among authors: archdeacon p. Pharmacoepidemiol Drug Saf. 2014 Jun;23(6):609-18. doi: 10.1002/pds.3580. Epub 2014 Feb 18. Pharmacoepidemiol Drug Saf. 2014. PMID: 24677577
Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association.
Gagne JJ, Han X, Hennessy S, Leonard CE, Chrischilles EA, Carnahan RM, Wang SV, Fuller C, Iyer A, Katcoff H, Woodworth TS, Archdeacon P, Meyer TE, Schneeweiss S, Toh S. Gagne JJ, et al. Among authors: archdeacon p. Clin Pharmacol Ther. 2016 Nov;100(5):558-564. doi: 10.1002/cpt.429. Epub 2016 Aug 22. Clin Pharmacol Ther. 2016. PMID: 27416001 Free PMC article.
Summary of the US FDA approval of belatacept.
Archdeacon P, Dixon C, Belen O, Albrecht R, Meyer J. Archdeacon P, et al. Am J Transplant. 2012 Mar;12(3):554-62. doi: 10.1111/j.1600-6143.2011.03976.x. Epub 2012 Feb 15. Am J Transplant. 2012. PMID: 22335273 Free article.
24 results