Last Updated: 09/26/2026
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Found 18 publications
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.
Journal: Clinical trials (London, England)
Published: November 18, 2018
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.
Journal: Pharmacoepidemiology and drug safety
Published: September 18, 2017
Sentinel Modular Program for Propensity Score-Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia.
Journal: Epidemiology (Cambridge, Mass.)
Published: July 07, 2017
Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative.
Journal: Clinical trials (London, England)
Published: May 16, 2017
Sponsors' and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials.
Journal: Clinical trials (London, England)
Published: March 28, 2017
Understanding the functions and operations of data monitoring committees: Survey and focus group findings.
Journal: Clinical trials (London, England)
Published: November 26, 2016
Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health Initiative.
Journal: Journal of the American Society of Nephrology : JASN
Published: July 13, 2016
Overcoming Barriers in Kidney Health-Forging a Platform for Innovation.
Journal: Journal of the American Society of Nephrology : JASN
Published: April 30, 2016
Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association.
Journal: Clinical pharmacology and therapeutics
Published: February 18, 2016
CKD as a Model for Improving Chronic Disease Care through Electronic Health Records.
Journal: Clinical journal of the American Society of Nephrology : CJASN
Published: June 27, 2015
The Clinical Trials Transformation Initiative: innovation through collaboration.
Journal: Nature reviews. Drug discovery
Published: November 01, 2014
Pharmacokinetic assessment in patients receiving continuous RRT: perspectives from the Kidney Health Initiative.
Journal: Clinical journal of the American Society of Nephrology : CJASN
Published: September 06, 2014
Last Updated: 09/26/2026