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

ECG/QT/Proarrhythmia/Arrhythmia

QT Proarrhythmia

• Considerations for assessing the potential effects of antidiabetes 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/QT/Proarrhythmia/Arrhythmia

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 Meeting & CSRC Think Tank: Detection, Assessment and Risk Mitigation of Cardiac Safety Signals in Oncology Drug Development
• CSRC Think Tank: Real World Data to Assess Cardiovascular Safety- Can We Improve Efficiencies in Phase 3 Development?