Understanding the Use of Negative Controls To Assess the Validity of Non-Interventional Studies of Treatment Using Real-World Evidence; Public Workshop; Request for Comments

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the following public workshop entitled "Understanding the Use of Negative Controls to Assess the Validity of Non-Interventional Studies of Treatment Using Real-World Evidence." Convened by the Duke-Margolis Center for Health Policy and supported by a cooperative agreement between FDA and Duke-Margolis, the purpose of this public workshop is to discuss existing negative control methodologies for studies based on real-world data and to outline advantages and disadvantages of the use of negative controls for evaluating the safety and effectiveness of regulated medical products. Additionally, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research will propose projects to develop negative control methods and implement new tools for use in the Sentinel System, Biologics Effectiveness and Safety (BEST) System, and with Federal Partners.