AI in Clinical Trials: Game Changer or Just Another Buzzword?

By Jenna Levenson, PhD, RN, MS

We’ve all seen the headlines:
“AI is revolutionizing drug development.”
“Machine learning will accelerate clinical trials.”
But here’s the real question biotech teams should be asking:
Are we building with AI—or just marketing with it?

As someone who’s spent years in the trenches of trial design, grant funding, and regulatory prep work, I’ve seen how slow, siloed systems completely choke innovation. AI has the potential to break those silos—but only if we use it strategically.

What AI Actually Brings to Clinical Research

Hype aside when applied smartly, AI isn’t replacing scientists—it’s amplifying them. Here’s where it's already making an impact:

• Predictive enrollment modeling: Say goodbye to months of under-recruitment. AI pinpoints patient pools before your trial stalls.

• Protocol optimization: Algorithms can flag feasibility red flags before your IRB does.

• Real-time monitoring & risk detection: Site performance, AE patterns, compliance gaps—surfaced faster than humans ever could.

• Natural language processing (NLP): AI can extract insights from unstructured data—think clinician notes, patient feedback, and even adverse event narratives.

And this is just the beginning.

But There Must Be A Catch…Right?

AI doesn’t work in a vacuum.

Your success still depends on the strategy behind the tool.
If your endpoints are fuzzy, your data pipelines broken, or your patient input missing—AI just accelerates the mess.

That’s why forward-thinking sponsors aren’t asking "Which AI do we buy?"
They’re asking:
"How do we redesign our trials to make AI worth using?"

AI Is a Mirror. What Will It Reflect in Your Trials?

You cannot automate your way out of a broken trial design. Let me say that again, you cannot automate your way out of a broken design.

But you can use AI to:

• Design smarter from day one

• Cut timelines without cutting corners

• Improve protocol diversity, efficiency, and regulatory readiness

• Amplify the patient voice at scale

Do Not Think of AI As the Future. It Is The Filter.

In the next 3–5 years, we won’t be asking if AI belongs in clinical trials.
We’ll be asking:
Did your trial pass through the AI filter—or get left behind?

If you’re navigating how to integrate AI into clinical operations—or unsure where to begin— Let’s Talk.