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Leveraging the Capabilities of the FDA's Sentinel System To Improve Kidney Care.
Adimadhyam S, Barreto EF, Cocoros NM, Toh S, Brown JS, Maro JC, Corrigan-Curay J, Dal Pan GJ, Ball R, Martin D, Nguyen M, Platt R, Li X. Adimadhyam S, et al. Among authors: cocoros nm. J Am Soc Nephrol. 2020 Nov;31(11):2506-2516. doi: 10.1681/ASN.2020040526. Epub 2020 Oct 19. J Am Soc Nephrol. 2020. PMID: 33077615 Free PMC article. Review.
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. Clin Trials. 2019 Feb;16(1):90-97. doi: 10.1177/1740774518812776. Epub 2018 Nov 16. Clin Trials. 2019. PMID: 30445835
A new analytic tool developed to assess safe use recommendations.
Cocoros NM, Wagner A, Haynes K, Petrone AB, Fazio-Eynullayeva E, Ding Y, Izem R, Lee JY, Major JM, Nguyen M, Ju J. Cocoros NM, et al. Pharmacoepidemiol Drug Saf. 2019 May;28(5):649-656. doi: 10.1002/pds.4724. Epub 2019 Feb 12. Pharmacoepidemiol Drug Saf. 2019. PMID: 30747473
Evaluation of the US Food and Drug Administration Sentinel Analysis Tools Using a Comparator with a Different Indication: Comparing the Rates of Gastrointestinal Bleeding in Warfarin and Statin Users.
Carnahan RM, Gagne JJ, Hampp C, Leonard CE, Toh S, Fuller CC, Hennessy S, Hou L, Cocoros NM, Panucci G, Woodworth T, Cosgrove A, Iyer A, Chrischilles EA. Carnahan RM, et al. Among authors: cocoros nm. Pharmaceut Med. 2019 Feb;33(1):29-43. doi: 10.1007/s40290-018-00265-w. Pharmaceut Med. 2019. PMID: 31933271
Using electronic health records to identify candidates for human immunodeficiency virus pre-exposure prophylaxis: An application of super learning to risk prediction when the outcome is rare.
Gruber S, Krakower D, Menchaca JT, Hsu K, Hawrusik R, Maro JC, Cocoros NM, Kruskal BA, Wilson IB, Mayer KH, Klompas M. Gruber S, et al. Among authors: cocoros nm. Stat Med. 2020 Oct 15;39(23):3059-3073. doi: 10.1002/sim.8591. Epub 2020 Jun 24. Stat Med. 2020. PMID: 32578905 Free PMC article.
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: cocoros nm. Clin Trials. 2020 Aug;17(4):360-367. doi: 10.1177/1740774520928426. Epub 2020 Jun 26. Clin Trials. 2020. PMID: 32589056 Free PMC article.
78 results