Detalhe da pesquisa
1.
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.
Clin Trials
; 16(1): 90-97, 2019 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-30445835
2.
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.
Pharmacoepidemiol Drug Saf
; 27(7): 731-739, 2018 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-29532543
3.
Sentinel Modular Program for Propensity Score-Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia.
Epidemiology
; 28(6): 838-846, 2017 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-28682851
4.
Sponsors' and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials.
Clin Trials
; 14(3): 225-233, 2017 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-28345368
5.
Understanding the functions and operations of data monitoring committees: Survey and focus group findings.
Clin Trials
; 14(1): 59-66, 2017 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-27885056
6.
Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative.
Clin Trials
; 14(4): 342-348, 2017 Aug.
Artigo
em Inglês
| MEDLINE | ID: mdl-28503947
7.
Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health Initiative.
J Am Soc Nephrol
; 27(10): 2955-2963, 2016 Oct.
Artigo
em Inglês
| MEDLINE | ID: mdl-27401689
8.
Overcoming Barriers in Kidney Health-Forging a Platform for Innovation.
J Am Soc Nephrol
; 27(7): 1902-10, 2016 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-27127187
9.
Electronic clinical laboratory test results data tables: lessons from Mini-Sentinel.
Pharmacoepidemiol Drug Saf
; 23(6): 609-18, 2014 Jun.
Artigo
em Inglês
| MEDLINE | ID: mdl-24677577
10.
CKD as a Model for Improving Chronic Disease Care through Electronic Health Records.
Clin J Am Soc Nephrol
; 10(8): 1488-99, 2015 Aug 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-26111857
11.
Pharmacokinetic assessment in patients receiving continuous RRT: perspectives from the Kidney Health Initiative.
Clin J Am Soc Nephrol
; 10(1): 159-64, 2015 Jan 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-25189923
12.
The Clinical Trials Transformation Initiative: innovation through collaboration.
Nat Rev Drug Discov
; 13(11): 797-8, 2014 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-25359366
13.
Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application.
Ther Innov Regul Sci
; 48(2): 200-207, 2014 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-30227498
14.
FDA perspective: enrolment of elderly transplant recipients in clinical trials.
Transplantation
; 95(7): 916-8, 2013 Apr 15.
Artigo
em Inglês
| MEDLINE | ID: mdl-23380880
15.
Fostering innovation, advancing patient safety: the kidney health initiative.
Clin J Am Soc Nephrol
; 8(9): 1609-17, 2013 Sep.
Artigo
em Inglês
| MEDLINE | ID: mdl-23744001
16.
Bone morphogenetic protein 7 (BMP7): a critical role in kidney development and a putative modulator of kidney injury.
Adv Chronic Kidney Dis
; 15(3): 314-20, 2008 Jul.
Artigo
em Inglês
| MEDLINE | ID: mdl-18565482