ERG Examining Use of Patient Experience Data in Regulatory Decision Making

Types of data collectors, mechanisms, and topics covered

Including patient voice and using patient experience data (e.g., impacts of disease and treatments, preferences about therapeutic trade-offs) in developing and evaluating new medical products are hot button issues in public health. ERG has been awarded a high-profile project to examine the types of patient experience data that product sponsors provide to the Food and Drug Administration (FDA), and how FDA uses these and other sources of patient experience information in regulatory decision making. ERG's project team will interface directly with leaders in FDA's Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Device and Radiologic Health for this project.