ARPA-H targets a four-year path from human trials to market

ARPA-H aims to cut the path from first human testing to market to four years

That path currently takes more than a decade on average. ARPA-H, the U.S. agency for high-risk biomedical research within the Department of Health and Human Services, announced the five-year SURPASS competition on September 30. Four years remains its target.

SURPASS is intended to build shared clinical trial infrastructure. Today, infrastructure and control groups are rebuilt for sequential Phase 1, 2 and 3 trials. The proposed platform would automate data collection and cleaning when new treatment groups are added. Digital twins, computer models of trials, would simulate studies in advance and determine how many participants are needed. Continuous analysis of incoming data would help researchers adjust a trial as it proceeds.

ARPA-H already has a related program, PROSPR. It seeks aging biomarkers, measurable indicators that could assess treatment effects sooner, without waiting decades for final outcomes. PROSPR focuses on those indicators, while SURPASS builds infrastructure for obtaining results faster. The source reports neither a formal integration of the programs nor results validating PROSPR biomarkers.

A shared platform presents a statistical difficulty. As treatment groups enter and leave, control-group data accumulate. Standards of care and patient populations may change during that time. A difference between a new treatment and the control could then partly reflect those changes, distorting the estimate of the treatment's effect. Continuous analysis must account for that risk to keep comparisons reliable.

ARPA-H involved the U.S. Food and Drug Administration (FDA), the drug regulator, early in planning. Its participation alone does not establish that future results will support drug approval. SURPASS is accepting proposals until January 2027; reducing the timeline to four years still needs to be demonstrated.
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Sources
[1] arpa-h.gov
[2] ox.ac.uk
[3] doi.org
[4] axios.com
[5] t.me