Sentinel Modular Program for Propensity Score–Matched Cohort Analyses

Autor: Ryan M. Carnahan, Joshua J. Gagne, Meijia Zhou, Christian Hampp, Candace C. Fuller, Sophia Axtman, Catherine A. Panozzo, Patrick Archdeacon, Charles E. Leonard, Sengwee Toh, Shirley V. Wang, Elizabeth Cavagnaro, Tiffany S. Woodworth, Elizabeth A. Chrischilles, Sean Hennessy, Aarthi Iyer

Publikováno v: Epidemiology. 28:838-846

Sentinel is a program sponsored by the US Food and Drug Administration to monitor the safety of medical products. We conducted a cohort assessment to evaluate the ability of the Sentinel Propensity Score Matching Tool to reproduce in an expedited fas

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ce0356b681d76ba85fddf33775cf9020
https://doi.org/10.1097/ede.0000000000000709

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

Autor: Nina Stuccio, Nancy Roach, Raymond P. Perez, Annemarie Forrest, Robert Goodwin, Patrick Archdeacon, Jonathan P. Jarow

Publikováno v: Clinical Trials (London, England)
Clin Trials

Background/aims: The Food and Drug Administration’s final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occur

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5fbfa9a009ec865ebf9da126adb13c0b
https://doi.org/10.1177/1740774517700640

Overcoming Barriers in Kidney Health—Forging a Platform for Innovation

Autor: Melissa West, Jennifer Snook, Prabir Roy-Chaudhury, Matthew D. Breyer, Jula K. Inrig, James A. Sloand, Ronald J. Falk, Carolyn Y. Neuland, Patrick Archdeacon, Reshma Kewalramani, Kimberly A. Smith, Tod Ibrahim, Rachel Meyer, Peter Linde, Celeste Castillo Lee

Publikováno v: Journal of the American Society of Nephrology. 27:1902-1910

Innovation in kidney diseases is not commensurate with the effect of these diseases on human health and mortality or innovation in other key therapeutic areas. A primary cause of the dearth in innovation is that kidney diseases disproportionately aff

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e039d8c4fd71eef2267d01a1499a899c
https://doi.org/10.1681/asn.2015090976

Challenges in conducting clinical trials in nephrology: Conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference

Autor: Marc A. Pfeffer, Wolfgang C. Winkelmayer, Kirsten L. Johansen, Fiona Loud, Katherine R. Tuttle, Faiez Zannad, Angela Yee-Moon Wang, Ikechi G. Okpechi, Richard K. Haynes, Dugan W. Maddux, Fergus Caskey, John J.V. McMurray, Garabed Eknoyan, Ali K. Abu-Alfa, Masaomi Nangaku, Adeera Levin, Patrick Rossignol, S. Mariz, Geoffrey A. Block, Barbara S. Gillespie, Allison Tong, Vlado Perkovic, Tom Greene, Colin Baigent, John S. Gill, Romaldas Maciulaitis, David C. Wheeler, Alfred K. Cheung, Peter Rossing, Franz Schaefer, Laura M. Dember, Joseph V. Nally, Michael V. Rocco, William G. Herrington, Charmaine E. Lok, Meg Jardine, Robert D. Toto, Hiddo J.L. Heerspink, Martin Lefkowitz, Marcello Tonelli, Michael Mauer, Francesca Tentori, Martin J Landray, Josef Coresh, Michael Walsh, Christoph Wanner, Thomas F. Hiemstra, Brian J.G. Pereira, Jonathan C. Craig, Aliza Thompson, Magdalena Madero, Patrick S. Parfrey, Franklin W. Maddux, Brenda R. Hemmelgarn, Lesley A. Inker, Vivekanand Jha, Thorsten Vetter, Reshma Kewalramani, Lixin Jiang, Roberto Pecoits-Filho, Charles A. Herzog, Patrick Archdeacon, Bruce A. Cooper, David Harris, Ron T. Gansevoort

Publikováno v: Baigent, C, Herrington, W G, Coresh, J, Landray, M J, Levin, A, Perkovic, V, Pfeffer, M A, Rossing, P, Walsh, M, Wanner, C, Wheeler, D C, Winkelmayer, W C, McMurray, J J V, KDIGO Controversies Conference on Challenges in the Conduct of Clinical Trials in Nephrology Conference Participants, Abu-Alfa, A, Archdeacon, P, Block, G A, Caskey, F J, Cheung, A K, Cooper, B, Craig, J C, Dember, L M, Eknoyan, G, Gansevoort, R T, Gill, J S, Gillespie, B, Greene, T, Harris, D C, Haynes, R, Hemmelgarn, B R, Herzog, C A, Hiemstra, T F, Inker, L A, Jardine, M J, Jha, V, Jiang, L, Johansen, K L, Kewalramani, R, Lambers Heerspink, H J, Lefkowitz, M, Lok, C E, Loud, F, Mačiulaitis, R, Maddux, D W, Maddux, F W, Madero, M, Mariz, S, Mauer, M, Nally, J V, Nangaku, M & Okpechi, I G 2017, ' Challenges in conducting clinical trials in nephrology : conclusions from a Kidney Disease—Improving Global Outcomes (KDIGO) Controversies Conference ', Kidney International, vol. 92, no. 2, pp. 297-305 . https://doi.org/10.1016/j.kint.2017.04.019

Despite the high costs of treatment of people with kidney disease and associated comorbid conditions, the amount of reliable information available to guide the care of such patients is very limited. Some treatments have been assessed in randomized tr

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::25e54ca6e445ad1afec4281a260441a8
http://ora.ox.ac.uk/objects/uuid:

Electronic clinical laboratory test results data tables: lessons from Mini-Sentinel

Autor: Patrick Archdeacon, Mark G. Weiner, Kevin Haynes, Kara O. Coughlin, Lesley H. Curtis, Jeffrey S. Brown, Gwyn Saylor, Tiffany S. Woodworth, Elizabeth Cavagnaro, Marsha A. Raebel

Publikováno v: Pharmacoepidemiology and Drug Safety. 23:609-618

Purpose Developing electronic clinical data into a common data model posed substantial challenges unique from those encountered with administrative data. We present here the design, implementation, and use of the Mini-Sentinel Distributed Database la

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::5c3525edd49e7b18b47841617dd8afb9
https://doi.org/10.1002/pds.3580