The role of hemovigilance and postmarketing studies when introducing innovation into transfusion medicine practice: the amotosalen-ultraviolet A pathogen reduction treatment model

摘要

BACKGROUNDInnovations in transfusion medicine require randomized controlled clinical trials (RCTs) to demonstrate safety and efficacy before approval; however, these studies are costly and limited in scope and may be underpowered to detect rare adverse events (AEs). Regulatory agencies, such as the Food and Drug Administration, require postmarketing surveillance, hemovigilance (HV), and controlled Phase IV studies to monitor performance and confirm safety.