CSRC: New Paradigms |ECG/QT/Proarrhythmia/Arrhythmia - QT Proarrhythmia | ECG/QT/Proarrhythmia/Arrhythmia - ECG Arrhythmias| Drug-Device Safety Interactions |Registries, Cardiovascular Outcomes, Adjudication, Adverse Event Reports | Cardiac Dysfunction | Cardiovascular Risk: Hypertension, Diabetes | NOACs | Papers in Process
CSRC: New Paradigms
- 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
Registries, Cardiovascular Outcomes, Adjudication, Adverse Event Reports
- 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
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