Real-World Evidence
The FDA noted the increasing role of Real-World Data (RWD) and Real-World Evidence (RWE) in healthcare decisions, emphasizing that the 21st Century Cures Act focuses on utilizing these data types for regulatory decision-making.
Manufacturers and developers of biological products, drugs, and medical devices, as well as clinical operations and regulatory strategy functions.
The formalization of RWE in regulatory pathways suggests that sponsors may have more opportunities to support label expansions or fulfill post-marketing requirements using non-traditional data sources. This likely necessitates a more robust approach to data integrity and validation for real-world sources to ensure they meet the Agency's standards for substantial evidence.
Regulatory teams should evaluate how RWD/RWE might supplement traditional clinical trial data for ongoing or future submissions. Data management protocols should ensure that RWD collection aligns with the evidentiary standards required for regulatory decision-making.
Real-world data (RWD) and real-world evidence (RWE) played an increasing role in health care decisions. The 21st Century Cures Act, passed in 2016, placed additional focus on the use of these types of data to support regulatory decision making.
Open in openFDA / FDA.gov