Publications

CSRC: New Paradigms

Assessing Cardiac Safety in Oncology Drug Development

Comparison of Automated Interval Measurements by Widely Used Algorithms in Digital Electrocardiographs

Long-term Electrocardiographic Safety Monitoring in Clinical Drug Development: A Report from the Cardiac Safety Research Consortium

The Cardiac Safety Research Consortium Enters its Second Decade

Comparison of Quality-of-Life Measures After Radial Versus Femoral Artery Access for Cardiac Catheterization in Women: Results of the SAFE-PCI for Women Quality-of-Life Substudy

Pediatric Cardiovascular Safety: Challenges in Drug and Device Development and Clinical Application

New Precompetitive Paradigms: Focus on Cardiac Safety

Current Challenges in the Evaluation of Cardiac Safety During Drug Development: Translational Medicine Meets the Critical Path Initiative

QT Proarrhythmia

Considerations for Assessing the Potential Effects of Anti-diabetes Drugs on Cardiac Ventricular Repolarization: A Report from the Cardiac Safety Research Consortium

Cardiac Safety Research Consortium: Can the Thorough QT/Qtc Study Be Replaced By Early QT Assessment In Routine Clinical Pharmacology Studies? Scientific Update and a Research Proposal for a Path Forward

Detection of QT Prolongation Using a Novel Electrocardiographic Analysis Algorithm Applying Intelligent Automation: Prospective Blinded Evaluation Using The Cardiac Safety Research Consortium Electrocardiographic Database

Methodologies to Characterize the QT/Corrected QT Interval in the Presence of Drug-Induced Heart Rate Changes or Other Autonomic Effects

Assessing Proarrhythmic Potential of Drugs When Optimal Studies Are Infeasible

ECG/Arrhythmias

The Evaluation and Management of Drug Effects On Cardiac Conduction (PR And QRS Intervals) In Clinical Development

Evaluation of Ventricular Arrhythmias In Early Clinical Pharmacology Trials And Potential Consequences For Later Development

Electrocardiographic Assessment for Therapeutic Proteins—Scientific Discussion

Drug-Device Safety Interactions

Evolution of Strategies to Improve Preclinical Cardiac Safety Testing

Registries, Cardiovascular Outcomes, Adjudication, Adverse Event Reports

Restricted Mean Survival Time for The Analysis Of Cardiovascular Outcome Trials Assessing Non-Inferiority: Case Studies From Antihyperglycemic Drug Development

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

Clinical Event Adjudication in Cardiovascular Device Trials: A Food and Drug Administration Perspective

Centralized Adjudication of Cardiovascular End Points In Cardiovascular And Noncardiovascular Pharmacologic Trials: A Report From The Cardiac Safety Research Consortium

Cardiovascular Safety Outcome Trials: A Meeting Report from The Cardiac Safety Research Consortium

Developing the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a Collaborative Pan-Stakeholder Critical Path Registry Model: A Cardiac Safety Research Consortium “Incubator” Think Tank

Cardiac Dysfunction

Prevention of Sudden Cardiac Death in the Young: Developing a Rational, Reliable, and Sustainable National Health Care Resource

Troponin Measurements During Drug Development – Considerations for Monitoring and Management of Potential Cardiotoxicity: An Educational Collaboration Among The Cardiac Safety Research Consortium, Duke Clinical Research Institute, and the US Food and Drug Administration

Cardiovascular Risk: Hypertension, Diabetes

Assessment of Drug-Induced Increases In Blood Pressure During Drug Development: Report from the Cardiac Safety Research Consortium

NOACs

Is There a Role for Pharmacokinetic/Pharmacodynamics Guided Dosing for Novel Anticoagulants?

NOAC Monitoring, Reversal Agents, and Post-Approval Safety and Effectiveness Evaluation: A Cardiac Safety Research Consortium Think Tank

Novel Oral Anticoagulants and Reversal Agents: Considerations for Clinical Development

Papers in Process

CSRC Think Tank: Shock II: Practical Approaches to Generating Clinical Evidence for the Treatment of Cardiogenic Shock

CSRC Think Tank: Shock III: Clinical and regulatory landscape for cardiogenic shock: A report from the Cardiac Safety Research Consortium ThinkTank on cardiogenic shock