HHS and FDA's "Operation Trialblazer": Accelerating Clinical Trials — Now with ARPA-H's SURPASS, STACK, COMMONS, and CINCH

HHS and FDA's "Operation Trialblazer": Accelerating Clinical Trials — Now with ARPA-H's SURPASS, STACK, COMMONS, and CINCH

Update, October 3, 2026. The clinical-trials modernization push under HHS Secretary Robert F. Kennedy Jr. gained a major new pillar on September 30, 2026, when ARPA-H launched SURPASS (Simulation-augmented, Real-time Platform Adaptive Seamless Trials) — "a major effort to transform how clinical trials are designed and conducted — using advanced computational models, real-time analysis, shared infrastructure, and automation to evaluate drugs and biologics faster, at lower cost, and with fewer participants¹."

Kennedy framed it as an attack on development economics: "HHS is taking on the delays, duplication, and unnecessary costs that slow clinical trials down. Through ARPA-H, we are building a modern clinical trial system that can generate rigorous evidence faster, reduce the burden on patients, and move effective treatments from discovery to the people who need them sooner." The release puts the stakes plainly: drug and biologic development "often takes more than a decade, costs up to $2 billion on average, and fails more than 90 percent of the time."

SURPASS pursues three technical areas:

• A "phaseless design engine" — digital twins and predictive models simulating clinical and operational outcomes before launch, to build "the evidence needed to support regulatory confidence in these approaches";
• A "continuous inference engine" — "always-valid, real-time or on-demand analysis," enabling rapid adaptation with smaller control groups;
• An "agentic operations layer" — automating trial startup, onboarding of new treatment arms, and data cleaning/dataset construction.

Three complementary infrastructure projects launched alongside it: STACK (AI to accelerate site activation and convert research-naïve sites into trial-capable ones), COMMONS (privacy-by-design national consent and regulatory-grade data-access architecture), and CINCH (patient-contributed real-world data and trial-matching). Program manager Daria Fedyukina: "SURPASS is developing the technology and biostatistical frameworks needed to analyze trial data as it accumulates, allowing teams can learn in real time, adapt when needed, and generate stronger evidence faster with less operational burden."

SURPASS slots in beside the original Operation Trailblazer apparatus (launched June 22, 2026 to speed trials and early-stage development), the FDA's Expedited IND Pilot (applications close Oct 30, 2026), and the CNPV voucher program — a coherent whole-of-government effort to compress the development timeline, now extending from regulatory review (FDA) into trial design and site infrastructure itself (ARPA-H)². An Innovative Solutions Opening for SURPASS is open; watch for awardees.