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Can AI Design Better Clinical Trials Than Humans?

What if AI becomes better at designing clinical trials than anyone else?

While Pharma has been navigating the digital transformation for years, 2025 felt different. It was a turning point, an awakening of sorts, when the entire life sciences sector seemed to jump on the AI bandwagon in record time.

AI became the new buzzword, almost replacing the digital transformation narrative. The new paradigm shift. The answer to slow processes, complex legacy systems, fragmented data, and regulatory hurdles. At the same time, a common opinion and answer to AI in clinical trials is, “AI, Absolutely! But a human is always in the loop”. And we fully agree that human in the loop is the gold standard.

But there is one rather uncomfortable question, the elephant in the room: What if AI becomes better at designing clinical trials than the clinical research industry itself?

Can AI actually become better at designing trials than the industry itself?

In juxtaposition to this question is the fact that, at this point, only a handful of AI-discovered or AI-designed drugs may have reached human trials, and none have yet made it to clinical approval. To be fair, considering that it takes, on average, up to 11 years to develop a new drug (DiMasi et al., 2016), we are still at the very beginning. Not enough time has passed quite yet to draw meaningful conclusions here. But check out this recent example led by Stanford professor James Zou: a “virtual biotech” comprising up to 37,000 AI agents, coordinated by an AI “chief scientist”, identified a promising lung-cancer treatment strategy and demonstrated how AI can rapidly generate evidence.

We are truly at a pivotal point. Exciting times that open the door to much bigger conversation, debate and new regulatory frameworks.

AI in clinical trials is our bread and butter. Undoubtedly. This is what we develop. We are an impact-driven organization, and our mission is to dramatically reduce the time and cost of clinical trials. We applaud any progress in that direction. But we also carefully evaluate and validate it. On a broader societal scale, we are observing these developments with curiosity while building the first end-to-end solution for clinical trial development that leverages AI and technology to simulate trial design, with the goal of reducing failure and cost.

As most companies are still pre-AI, rather than answering the closed question proposed earlier, it is worth encouraging deeper contemplation of three questions that all of us implementing AI in clinical trials should be prepared to answer:

  • How do we properly transfer knowledge to clinical teams so that AI can be used appropriately and responsibly?

  • Should “we’ve always done it this way” ever be an ethical justification in medicine when AI offers credible alternatives?

  • Could using AI eventually become an ethical obligation rather than an optional?

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@2026 Biorce | All Rights Reserved

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Get the inside track on clinical trial innovation Insights that pharma leaders actually read. No fluff.

Submit

@2026 Biorce | All Rights Reserved

Partners with

Get the inside track on clinical trial innovation Insights that pharma leaders actually read. No fluff.

Submit

Partners with

@2026 Biorce | All Rights Reserved