Everyone Talks About This… But They’re Missing the FDA’s Real Signal
By Jenna Levenson, PhD, RN, MS
Everyone talks about endpoints.
Primary. Secondary. Exploratory.
Yes—they matter. But they’re not what moves the FDA anymore.
You know what does?
The patient voice.
The real-world narrative behind the numbers.
The story of how your treatment changes lives—not just biomarkers.
I’ve sat on both sides of the table: as a clinical researcher at Johns Hopkins, and as a consultant helping biotech companies get their science funded, reviewed, and approved. I’ve reviewed protocols that were airtight statistically… and still got stuck in limbo.
Why?
Because they ignored the one thing that’s becoming non-negotiable in 2025:
Incorporating patient voice into clinical trial strategy.
Why Does This Matter?
Regulatory agencies are no longer impressed by data alone. They want to know:
How does your intervention feel to the patient?
What symptoms are actually meaningful to their daily lives?
Is your trial designed with burden, equity, and access in mind?
In other words: does your protocol reflect the real world?
Here’s what most trial teams miss.. Patient-reported outcomes, lived experience insights, and qualitative input can:
Accelerate FDA alignment
De-risk submissions
Strengthen funding applications
Improve recruitment and retention
And yet... few teams have a built-in strategy to collect, synthesize, and leverage this kind of data.
What I Do Differently
This is where I step in.
I help biotech teams:
Integrate the patient voice at the protocol level
Build FDA- and investor-ready narratives grounded in lived experience
Design studies that are fundable, feasible, and patient-centered
Because science without strategy… gets expensive fast.
Final Word
Endpoints are 100% essential. But they’re not enough.
Start asking:
Have we defined success the way patients would?
Are we capturing impact that regulators want to see?
Are our outcomes aligned with what people actually care about?
If not, let’s talk.