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Items: 22


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.

Clin Trials. 2019 Feb;16(1):90-97. doi: 10.1177/1740774518812776. Epub 2018 Nov 16.


Evaluation of the US Food and Drug Administration sentinel analysis tools in confirming previously observed drug-outcome associations: The case of clindamycin and Clostridium difficile infection.

Carnahan RM, Kuntz JL, Wang SV, Fuller C, Gagne JJ, Leonard CE, Hennessy S, Meyer T, Archdeacon P, Chen CY, Panozzo CA, Toh S, Katcoff H, Woodworth T, Iyer A, Axtman S, Chrischilles EA.

Pharmacoepidemiol Drug Saf. 2018 Jul;27(7):731-739. doi: 10.1002/pds.4420. Epub 2018 Mar 13.


Sentinel Modular Program for Propensity Score-Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia.

Zhou M, Wang SV, Leonard CE, Gagne JJ, Fuller C, Hampp C, Archdeacon P, Toh S, Iyer A, Woodworth TS, Cavagnaro E, Panozzo CA, Axtman S, Carnahan RM, Chrischilles EA, Hennessy S.

Epidemiology. 2017 Nov;28(6):838-846. doi: 10.1097/EDE.0000000000000709.


Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative.

Calis KA, Archdeacon P, Bain R, DeMets D, Donohue M, Elzarrad MK, Forrest A, McEachern J, Pencina MJ, Perlmutter J, Lewis RJ.

Clin Trials. 2017 Aug;14(4):342-348. doi: 10.1177/1740774517707743. Epub 2017 May 13.


Sponsors' and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials.

Perez R, Archdeacon P, Roach N, Goodwin R, Jarow J, Stuccio N, Forrest A.

Clin Trials. 2017 Jun;14(3):225-233. doi: 10.1177/1740774517700640. Epub 2017 Mar 26.


Understanding the functions and operations of data monitoring committees: Survey and focus group findings.

Calis KA, Archdeacon P, Bain RP, Forrest A, Perlmutter J, DeMets DL.

Clin Trials. 2017 Feb;14(1):59-66. doi: 10.1177/1740774516679665. Epub 2016 Nov 24.


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.

Clin Pharmacol Ther. 2016 Nov;100(5):558-564. doi: 10.1002/cpt.429. Epub 2016 Aug 22.


Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health Initiative.

Dember LM, Archdeacon P, Krishnan M, Lacson E Jr, Ling SM, Roy-Chaudhury P, Smith KA, Flessner MF.

J Am Soc Nephrol. 2016 Oct;27(10):2955-2963. Epub 2016 Jul 11. Review.


Overcoming Barriers in Kidney Health-Forging a Platform for Innovation.

Linde PG, Archdeacon P, Breyer MD, Ibrahim T, Inrig JK, Kewalramani R, Lee CC, Neuland CY, Roy-Chaudhury P, Sloand JA, Meyer R, Smith KA, Snook J, West M, Falk RJ.

J Am Soc Nephrol. 2016 Jul;27(7):1902-10. doi: 10.1681/ASN.2015090976. Epub 2016 Apr 28.


CKD as a Model for Improving Chronic Disease Care through Electronic Health Records.

Drawz PE, Archdeacon P, McDonald CJ, Powe NR, Smith KA, Norton J, Williams DE, Patel UD, Narva A.

Clin J Am Soc Nephrol. 2015 Aug 7;10(8):1488-99. doi: 10.2215/CJN.00940115. Epub 2015 Jun 25.


The Clinical Trials Transformation Initiative: innovation through collaboration.

Tenaerts P, Madre L, Archdeacon P, Califf RM.

Nat Rev Drug Discov. 2014 Nov;13(11):797-8. doi: 10.1038/nrd4442.


Pharmacokinetic assessment in patients receiving continuous RRT: perspectives from the Kidney Health Initiative.

Nolin TD, Aronoff GR, Fissell WH, Jain L, Madabushi R, Reynolds K, Zhang L, Huang SM, Mehrotra R, Flessner MF, Leypoldt JK, Witcher JW, Zineh I, Archdeacon P, Roy-Chaudhury P, Goldstein SL; Kidney Health Initiative.

Clin J Am Soc Nephrol. 2015 Jan 7;10(1):159-64. doi: 10.2215/CJN.05630614. Epub 2014 Sep 4.


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.

Pharmacoepidemiol Drug Saf. 2014 Jun;23(6):609-18. doi: 10.1002/pds.3580. Epub 2014 Feb 18.


Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application.

Archdeacon P, Grandinetti C, Vega JM, Balderson D, Kramer JM.

Ther Innov Regul Sci. 2014 Mar;48(2):200-207. doi: 10.1177/2168479013509382.


Fostering innovation, advancing patient safety: the kidney health initiative.

Archdeacon P, Shaffer RN, Winkelmayer WC, Falk RJ, Roy-Chaudhury P.

Clin J Am Soc Nephrol. 2013 Sep;8(9):1609-17. doi: 10.2215/CJN.01140113. Epub 2013 Jun 6.


Summary of FDA workshop on ischemia reperfusion injury in kidney transplantation.

Cavaillé-Coll M, Bala S, Velidedeoglu E, Hernandez A, Archdeacon P, Gonzalez G, Neuland C, Meyer J, Albrecht R.

Am J Transplant. 2013 May;13(5):1134-48. doi: 10.1111/ajt.12210. Epub 2013 Apr 8. Review.


FDA perspective: enrolment of elderly transplant recipients in clinical trials.

Meyer JM, Archdeacon P, Albrecht R.

Transplantation. 2013 Apr 15;95(7):916-8. doi: 10.1097/TP.0b013e31828279d9.


Summary of the US FDA approval of belatacept.

Archdeacon P, Dixon C, Belen O, Albrecht R, Meyer J.

Am J Transplant. 2012 Mar;12(3):554-62. doi: 10.1111/j.1600-6143.2011.03976.x. Epub 2012 Feb 15.


Summary of FDA antibody-mediated rejection workshop.

Archdeacon P, Chan M, Neuland C, Velidedeoglu E, Meyer J, Tracy L, Cavaille-Coll M, Bala S, Hernandez A, Albrecht R.

Am J Transplant. 2011 May;11(5):896-906. doi: 10.1111/j.1600-6143.2011.03525.x.


Bone morphogenetic protein 7 (BMP7): a critical role in kidney development and a putative modulator of kidney injury.

Archdeacon P, Detwiler RK.

Adv Chronic Kidney Dis. 2008 Jul;15(3):314-20. doi: 10.1053/j.ackd.2008.04.011. Review.


Identification of acetylcholine receptor channel-lining residues in the entire M2 segment of the alpha subunit.

Akabas MH, Kaufmann C, Archdeacon P, Karlin A.

Neuron. 1994 Oct;13(4):919-27.


Amino acid residues lining the chloride channel of the cystic fibrosis transmembrane conductance regulator.

Akabas MH, Kaufmann C, Cook TA, Archdeacon P.

J Biol Chem. 1994 May 27;269(21):14865-8.

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