Patient and Stakeholder Engagement

Premier Insight 253: Is it Safe or Not? Ask a Panel of Independent Experts

When it comes to study data, not everything can be easily measured and reflected by numbers. In a recent trial of a new occluder device for transcatheter closure of secundum atrial septal defects, the primary efficacy endpoint of defect closure was easy to measure in millimeters of possible residual shunt. However, assessment of the safety of the device in terms of postoperative complications and device- or procedure-related adverse events was more complex.