Publications by authors named "Jonathan Seltzer"

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Cardiovascular Sciences Research Consortium Think Tank: Remote Monitoring for Cardiac Safety in Clinical Trials.
Krishna Pundi, Sanjeev Bhavnani, Rosalyn Adigun, Jose Vicente, Rajesh Ghosh, Jonathan Seltzer

JACC Adv· September 2025

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Cardiovascular Safety in Oncology Clinical Trials: JACC: CardioOncology Primer.
Marc P Bonaca, Ninian N Lang, Alice Chen, Laleh Amiri-Kordestani, Leslie Lipka, Jonathan Seltzer

JACC CardioOncol· February 2025

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Independence of clinical events committees: A consensus statement from clinical research organizations.
Ernest Spitzer, Alexander C Fanaroff, C Michael Gibson, Jonathan Seltzer, Eugene McFadden

Am Heart J· June 2022

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Clinical events classification (CEC) in clinical trials: Report on the current landscape and future directions - proceedings from the CEC Summit 2018.
Abhinav Sharma, Kenneth W Mahaffey, Charles Michael Gibson, Karen A Hicks, Karen P Alexander, Jonathan Seltzer

Am Heart J· April 2022

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Correction: Retrospective analysis of arterial occlusive events in the PACE trial by an independent adjudication committee.
James L Januzzi, Joseph M Garasic, Scott E Kasner, Vickie McDonald, Mark C Petrie, Jonathan Seltzer

J Hematol Oncol· March 2022

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The COVID-19 pandemic and cardiovascular issues in clinical trials: Practical and regulatory issues in remote monitoring of cardiac safety.
Jonathan Seltzer, Fortunato Senatore, Ken Faulkner, Kenneth Martin Stein, Lt Stephen Browning

Am Heart J· January 2022

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Retrospective analysis of arterial occlusive events in the PACE trial by an independent adjudication committee.
James L Januzzi, Joseph M Garasic, Scott E Kasner, Vickie McDonald, Mark C Petrie, Jonathan Seltzer

J Hematol Oncol· January 2022

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Gaining Efficiency in Clinical Trials With Cardiac Biomarkers: JACC Review Topic of the Week.
James L Januzzi, John M Canty, Saumya Das, Christopher R DeFilippi, Gary A Gintant, Jonathan H Seltzer

J Am Coll Cardiol· April 2021

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Cardiac safety research consortium "shock II" think tank report: Advancing practical approaches to generating evidence for the treatment of cardiogenic shock.
Marc D Samsky, Mitchell W Krucoff, David A Morrow, William T Abraham, Fernando Aguel, Jonathan H Seltzer

Am Heart J· December 2020

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Defining the path ahead for NOAC use in the pediatric population: A Cardiac Safety Research Consortium Think Tank.
Jonathan H Seltzer, Ann Farrell, Neil Goldenberg, Christoph Hornik, Daniel Keene

Am Heart J· June 2020

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Commentary: In the Rising Era of Big Data, Small Steps are Key.
Nina Heller, Jonathan H Seltzer

Ethn Dis· March 2020

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Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions.
Greg Ball, Raffael Kurek, Barbara A Hendrickson, James Buchanan, William W Wang, Jonathan H Seltzer

Ther Innov Regul Sci· March 2020

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Corrigendum to "Assessing cardiac safety in oncology drug development" [Am Heart J 214 (2019) 125-133].
Jonathan H Seltzer, Gary Gintant, Laleh Amiri-Kordestani, Jack Singer, Luana Pesco Koplowitz

Am Heart J· December 2019

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The changing landscape of data monitoring committees-Perspectives from regulators, members, and sponsors.
Amit Bhattacharyya, Paul Gallo, Adam Crisp, Lisa LaVange, Geert Molenberghs, Jonathan Seltzer

Biom J· September 2019

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Assessing cardiac safety in oncology drug development.
Jonathan H Seltzer, Gary Gintant, Laleh Amiri-Kordestani, Jack Singer, Luana Pesco Koplowitz

Am Heart J· August 2019

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Critical Appraisal of Contemporary Clinical Endpoint Definitions in Coronary Intervention Trials: A Guidance Document.
Ernest Spitzer, Eugene McFadden, Pascal Vranckx, Hector M Garcia-Garcia, Jonathan H Seltzer

JACC Cardiovasc Interv· May 2019

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Cardiovascular outcome trials in patients with chronic kidney disease: challenges associated with selection of patients and endpoints.
Patrick Rossignol, Rajiv Agarwal, Bernard Canaud, Alan Charney, Gilles Chatellier, Jonathan Seltzer

Eur Heart J· March 2019

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Interdisciplinary Safety Evaluation and Quantitative Safety Monitoring: Introduction to a Series of Papers.
Jonathan H Seltzer, Judy Li, William Wang

Ther Innov Regul Sci· March 2019

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A Path Forward for Regenerative Medicine.
Alexander C Fanaroff, Valarie Morrow, Mitchell W Krucoff, Jonathan H Seltzer, Emerson C Perin

Circ Res· August 2018

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Safety Reporting: It Can Enter the 21st Century-If We Let It.
Jonathan Seltzer, Amit Bhattacharyya

Ther Innov Regul Sci· May 2018

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Is there a role for pharmacokinetic/pharmacodynamic-guided dosing for novel oral anticoagulants?
Noel Chan, Philip T Sager, Jack Lawrence, Thomas's Ortel, Paul Reilly, Jonathan H Seltzer

Am Heart J· May 2018

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Prevalent and Incident Heart Failure in Cardiovascular Outcome Trials of Patients With Type 2 Diabetes.
Stephen J Greene, Muthiah Vaduganathan, Muhammad Shahzeb Khan, George L Bakris, Matthew R Weir, Jonathan H Seltzer

J Am Coll Cardiol· March 2018

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Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium.
Jonathan H Seltzer, Ted Heise, Peter Carson, Daniel Canos, Jo Carol Hiatt

Am Heart J· August 2017

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Responsibilities of Data Monitoring Committees: Consensus Recommendations.
Barbara E Bierer, Rebecca Li, Jonathan Seltzer, Lynn A Sleeper, Elizabeth Frank

Ther Innov Regul Sci· September 2016

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Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency.
Jaime Arango, Tina Chuck, Susan S Ellenberg, Bridget Foltz, Colleen Gorman, Jonathan Seltzer

Ther Innov Regul Sci· July 2016

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