ARPA-H SURPASS programme targets phaseless clinical trials

By Emily Letton | Published: 15-Oct-2026 Emily Letton
Regulatory Research & Development

The US agency’s SURPASS programme aims to replace sequential Phase I-III trials with continuous adaptive studies, raising questions for clinical supply and manufacturing readiness

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ARPA-H SURPASS programme targets phaseless clinical trials

The US Department of Health and Human Services (HHS) has launched SURPASS, an Advanced Research Projects Agency for Health (ARPA-H) programme that seeks to replace the traditional phased model of drug development with continuous, adaptive platform trials.

The Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) programme was announced at the end of September alongside three complementary projects.

ARPA-H says clinical development of drugs and biologics currently takes more than a decade, costs up to $2bn on average and fails more than 90% of the time.

It aims to shorten development to under four years. 

What is SURPASS?

SURPASS combines predictive computational models, shared trial infrastructure, common control groups and real-time analysis.

It has the following three technical areas:

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