Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.
Real-World Evidence (RWE) is the clinical evidence regarding the usage, and potential benefits and risks, of a medical project derived from analysis of RWD.
The focus of this meeting and project is to explore the appropriate use of electronic health records and payment claims (RWD) in randomized clinical trials (RCTs) to generate RWE to support regulatory decision-making.
Present findings from evidence gathering activities.
Identify barriers and potential solutions to generating RWE for regulatory submissions from these RWD sources.
Describe what recommendations and resources CTTI should develop to equip change agents to increase appropriate use of RWD in RCTs, including to support regulatory submissions.