FDA Guidance on RWD and Externally Controlled Trials Leaves Stakeholders Confused

A recent draft guidance by the US Food and Drug Administration (FDA) on the use of real-world data (RWD) and externally controlled trials has many stakeholders asking for further clarification on several key points. In particular, many left public comments asking for specific examples of how handle issues when using real-world evidence (RWE).

According to Jeff Craven, “Commenters also identified several potential issues with the draft guidance, such as not completely addressing the issue of using external controls, not describing the use of hybrid control data, unclear proposals for documentation surrounding RWD and RWE, issues involving study design, and concerns about utilization for pediatric and rare diseases.”

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(Source: RAPS, May 3^rd, 2023)