Patrick Archdeacon
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View article: 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
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 Open
Background: The US Food and Drug Administration’s Sentinel Initiative is well positioned to support pragmatic clinical trials. FDA-Catalyst combines direct contact with health plan members and/or providers with data in the Sentinel infrast…
View article: Challenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease—Improving Global Outcomes (KDIGO) Controversies Conference
Challenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease—Improving Global Outcomes (KDIGO) Controversies Conference Open
View article: Sentinel Modular Program for Propensity Score–Matched Cohort Analyses
Sentinel Modular Program for Propensity Score–Matched Cohort Analyses Open
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 ex…
View article: Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative
Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative Open
Background/aims Use of data monitoring committees to oversee clinical trials was first proposed nearly 50 years ago. Since then, data monitoring committee use in clinical trials has increased and evolved. Nonetheless, there are no well-def…
View article: Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials
Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials Open
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 reacti…
View article: Understanding the functions and operations of data monitoring committees: Survey and focus group findings
Understanding the functions and operations of data monitoring committees: Survey and focus group findings Open
Background: The use of data monitoring committees in the conduct of clinical trials has increased and evolved, but there is a lack of published information on when data monitoring committees are needed and utilized, the acceptable range of…
View article: Issue Information – TOC
Issue Information – TOC Open
Drug transporters are of critical importance as they regulate pharmacokinetic properties of drugs (absorption, distribution, and elimination) and can cause the development of cellular drug resistance through decreased uptake or increased e…
View article: Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug‐Adverse Event Association
Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug‐Adverse Event Association Open
The US Food and Drug Administration's Sentinel system has developed the capability to conduct active safety surveillance of marketed medical products in a large network of electronic healthcare databases. We assessed the extent to which th…
View article: Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health Initiative
Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health Initiative Open
Pragmatic clinical trials are conducted under the real-world conditions of clinical care delivery. As a result, these trials yield findings that are highly generalizable to the nonresearch setting, identify interventions that are readily t…
View article: Overcoming Barriers in Kidney Health—Forging a Platform for Innovation
Overcoming Barriers in Kidney Health—Forging a Platform for Innovation Open
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 disproporti…