New guidance from the U.S. Food and Drug Administration (FDA) addresses considerations for the use of data standards currently supported by the agency in applicable drug submissions containing study data derived from real-world data (RWD) sources. For the purposes of the guidance, FDA defines RWD as data relating to individual patient health status or the delivery of healthcare routinely collected from a variety of sources.
Examples of RWD include data from electronic health records (EHRs); medical claims data; data from product and disease registries; patient-generated data (including data from in-home-use settings); and data gathered from other sources that can inform on health status, such as mobile devices.
“FDA recognizes the challenges involved in standardizing study data derived from RWD sources for inclusion in applicable drug submissions,” the agency writes in the guidance. These challenges include but are not limited to:
- The variety of RWD sources and their inconsistent formats (e.g., EHRs, registries);
- The differences in source data captured regionally and globally using different standards, terminologies, and exchange formats for the representation of the same or similar data elements;
- A wide range of methods and algorithms used to create datasets intended to aggregate data; and
- The many aspects of healthcare data that can affect the overall quality of the data, including business processes and database structure, inconsistent vocabularies and coding systems, and de-identification methodologies used to protect patient data when shared.
Edited by Michael Causey