Zobrazeno 1 - 10
of 57
pro vyhledávání: '"Nicolle M. Gatto"'
Autor:
Michael J. Eckrote, Carrie M. Nielson, Mike Lu, Tyler Alexander, Rikisha Shah Gupta, Kim Wah Low, Zhiwei Zhang, Austin Eliazar, Reyna Klesh, Andrew Kress, Matt Bryant, Alex Asiimwe, Nicolle M. Gatto, Nancy A. Dreyer
Publikováno v:
Contemporary Clinical Trials Communications, Vol 41, Iss , Pp 101354- (2024)
In drug development, the use of real-world data (RWD) has augmented our understanding of patients’ health care experiences and the effects of treatments beyond clinical trials. Although electronic health record (EHR) data integration at clinical tr
Externí odkaz:
https://doaj.org/article/a59ff5c32e22499a909e1901e20a6b10
Treatment effectiveness in a rare oncology indication: Lessons from an external control cohort study
Autor:
Dina Oksen, Patricia Prince, Emmanuelle Boutmy, Elizabeth M. Garry, Barbara Ellers‐Lenz, Adina Estrin, Andreas Johne, Patrice Verpillat, Nicolle M. Gatto
Publikováno v:
Clinical and Translational Science, Vol 15, Iss 8, Pp 1990-1998 (2022)
Abstract Real‐world data (RWD) reflecting patient treatment in routine clinical practice can be used to develop external control groups for single‐arm trials. External controls can provide valuable benchmark results on potential comparator drug e
Externí odkaz:
https://doaj.org/article/2ca7f2e918c842a88cefcea8b7b2b902
Autor:
Sarah E. Vititoe, Imaani J. Easthausen, Tamar Lasky, Aloka Chakravarty, Marie C. Bradley, Laura M. Roe, Nicolle M. Gatto, Andrew R. Weckstein, Elizabeth M. Garry
Publikováno v:
PLoS ONE, Vol 17, Iss 9 (2022)
Objective To describe differences by race and ethnicity in treatment patterns among hospitalized COVID-19 patients in the US from March-August 2020. Methods Among patients in de-identified Optum electronic health record data hospitalized with COVID-1
Externí odkaz:
https://doaj.org/article/68193dbe7e794c238c70ee568ad8b89c
Autor:
Nicolle M. Gatto, Michael B. Bracken, Francesca Kolitsopoulos, William T. Duggan, Gary G. Koch, Robert A. Wise, Neville C. Jackson
Publikováno v:
Contemporary Clinical Trials Communications, Vol 18, Iss , Pp 100427- (2020)
Objective: VOLUME is a randomized, open-label, post-approval pragmatic trial aiming to evaluate long-term pulmonary and cardiovascular safety of Exubera® (EXU; insulin human [rDNA origin] Inhalation Powder) in routine clinical practice. The primary
Externí odkaz:
https://doaj.org/article/e4aa5d4f7218450fa8223f858d591933
Autor:
Francesca M. Kolitsopoulos, Nicolle M. Gatto, Kevin Sweetland, Michael B. Bracken, Neville Jackson
Publikováno v:
Contemporary Clinical Trials Communications, Vol 16, Iss , Pp - (2019)
Introduction: Many clinical trials terminate early due to safety and efficacy concerns, and less often due to unexpected “positive” findings. However, early termination of post-approval (Phase IV) pragmatic randomized trials for commercial reason
Externí odkaz:
https://doaj.org/article/fb77d9ed4ce345c8b6b604959bed5146
Publikováno v:
Clinical Pharmacology & Therapeutics. 113:1235-1239
Autor:
Katherine E, Mues, Brenna, Kirk, Deesha A, Patel, Alice, Gelman, L Scott, Chavers, Carla A, Talarico, Daina B, Esposito, David, Martin, James, Mansi, Xing, Chen, Nicolle M, Gatto, Nicolas, Van de Velde
Publikováno v:
Vaccine. 40:6730-6739
Head-to-head studies comparing COVID-19 mRNA vaccine effectiveness in immunocompromised individuals, who are vulnerable to severe disease are lacking, as large sample sizes are required to make meaningful inferences.This observational comparative eff
Autor:
Elizabeth M. Garry, Andrew R. Weckstein, Kenneth Quinto, Marie C. Bradley, Tamar Lasky, Aloka Chakravarty, Sandy Leonard, Sarah E. Vititoe, Imaani J. Easthausen, Jeremy A. Rassen, Nicolle M. Gatto
Publikováno v:
Pharmacoepidemiology and Drug Safety. 31:721-728
Algorithms for classification of inpatient COVID-19 severity are necessary for confounding control in studies using real-world data.Using Healthverity chargemaster and claims data, we selected patients hospitalized with COVID-19 between April 2020 an
Autor:
Joshua J. Gagne, Jerry Avorn, Nicolle M. Gatto, Jingping Mo, Gerald J. Dal Pan, June Raine, Shinobu Uzu, Aaron S. Kesselheim, Kerstin N. Vokinger
Publikováno v:
Textbook of Pharmacoepidemiology. :73-111
Autor:
Nicolle M. Gatto, Shirley V. Wang, William Murk, Pattra Mattox, M. Alan Brookhart, Andrew Bate, Sebastian Schneeweiss, Jeremy A. Rassen
Publikováno v:
Pharmacoepidemiology and drug safetyREFERENCES. 31(11)
Transparency is increasingly promoted to instill trust in nonrandomized studies using real-world data. Graphics and data visualizations support transparency by aiding communication and understanding, and can inform study design and analysis decisions