D
Dilesh Doshi
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Sep 21, 2026
The Rise of Real-World Evidence in Regulatory Strategy, Part 1: RWE in Rare Disease Drug Development
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9:14Wayne PinesHOST
How do you define real world evidence? in the context of today's FDA, particularly as it relates to rare diseases.

Dilesh DoshiGUEST
I think I'm going to... dissect your questions in three parts, because I think it's important to provide perspective on the definition, as you said, asked for the real-world evidence.

Dilesh DoshiGUEST
You said today's FDA, so I want to come back to some of the comments Bethany made a minute ago in rare disease.

Dilesh DoshiGUEST
So, you know, if we keep it simple, FDA has definition that they have released around real-world evidence, real-world data, right? And So I think we can always refer to that.

Dilesh DoshiGUEST
From my perspective, it's really data that's the how and the where of the data, right? From a drug developer's perspective, our gold standards, our development programs are centered on clinical trial.

Dilesh DoshiGUEST
And that's our currency, essentially, right? Real-world evidence is everything else outside that.
9 MINS LATER