The FDA has acknowledged the challenges sponsors face in standardizing study data taken from real-world data (RWD) sources and issued draft guidance to help sponsors make adjustments.

These hurdles include the variety of RWD sources and their inconsistent formats; the differences in source data obtained regionally and globally using different standards, exchange formats and terminologies to represent the same or similar data elements; the variety of methods and algorithms used to make datasets meant to aggregate data; and the many elements of healthcare data that can impact overall data quality.

Sponsors are required to use the data formats and standards outlined in the agency’s Study Data Guidance and Data Standards Catalog when submitting study data derived from RWD in investigational new drug (IND) applications.

Because of this, the agency advises sponsors to refer to the Study Data Technical Conformance Guide, which outlines how to submit standardized study data that meet agency expectations.

In addition, when conforming RWD to agency-supported data standards, sponsors should consider the data transformations, conversions or mappings that may be needed to produce adequate study datasets. To aid them in this, the guidance provides sponsors with considerations to make when mapping and transforming RWD.

Importantly, sponsors are encouraged to communicate with the FDA early on if they plan to include study data taken from RWD sources in an applicable submission. If so, they should describe the approaches they intend to use to convert the data to supported data standards in the protocol, data management plan and/or final study reports.

The FDA said it intends to release further guidance on the subject and/or update the catalog with standards for study data taken from RWD sources.

Read the full guidance here: https://bit.ly/3C3LXQF.