Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS)

This solicitation (ARPA-H-SOL-26-164) is an Innovative Solutions Opening (ISO) issued by the Advanced Research Projects Agency for Health (ARPA-H) Proactive Health Office. It seeks proposals to establish the Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program. Aligned with HHS’s Operation TrialBlazer, SURPASS aims to modernize and accelerate clinical drug development by replacing traditional, fragmented clinical trial phases with a persistent, adaptive, and "phaseless" platform trial. The program is structured across three integrated Technical Areas (TAs): - **TA1 (Phaseless Design Engine):** Creates a simulation-based design environment incorporating in silico capabilities (such as digital twins and generative disease-progression models) to optimize trial designs and reduce control-group allocation. - **TA2 (Continuous Inference):** Develops statistical frameworks for real-time decision-making, adaptive randomization, and the graduated replacement of human controls with in silico data without compromising regulatory validity. - **TA3 (Agentic Operations):** Utilizes AI-enabled automation to streamline trial operations, including rapid site activation, contract execution, regulatory submissions, and automated data cleaning. SURPASS is a five-year program divided into Stage I (Buildout, Months 1–24) and Stage II (Validation and Deployment, Months 25–60). Core Platform Teams must address all three TAs, establish a platform network of at least six clinical sites, and secure FDA IND clearance for a Master Protocol with at least three initial investigational arms. Eligible commercial, academic, and non-profit entities must submit a 4-page Solution Summary by November 30, 2026. Selected proposers will be invited to submit a detailed Solution Pitch Package and deliver a virtual presentation in February 2027.

This document is a template for Attachment 1 (Scope of Work) for the federal solicitation ARPA-H-SOL-26-164, titled SURPASS. It provides a structured format for applicants to outline their planned technical tasks, subtasks, and sub-subtasks over a performance period of up to 60 months. The template requires applicants to detail the objectives, responsible organizations, performance locations, and comprehensive technical approaches for each proposed task. Crucially, applicants must identify whether any phase of the work involves Animal Subject Research (ASR) or Human Subject Research (HSR) and provide corresponding descriptions. Additionally, the template instructs applicants to define measurable, observable milestones—explicitly identifying which milestones are payable—and specify deliverables such as data, reports, regulatory documents, or models. The SOW is designed to align directly with the project's Cost Workbook to ensure administrative and financial consistency.

This document provides instructions and templates for the ARPA-H Cost Proposal Workbook, a mandatory tool used by both Prime Proposers and Subproposers to estimate and submit project costs for federal solicitations. The workbook features a standardized structure designed to collect comprehensive cost details across a project lifespan of up to five years (60 months). Key components of the workbook include: - **Project Cost Summary:** Automatically aggregates the ARPA-H funding share, performer cost share, and total costs across 16 possible task categories. - **Task-Based Cost Projections:** Requires proposers to align task starts and durations with their project Gantt charts and Statement of Work (SOW) subtasks. - **Cost Categorization:** Captures direct labor (by labor category, hours, and rates), fringe benefits, labor overhead, subcontractor and consultant fees, and other direct costs (ODCs) such as materials, equipment, and travel. - **Indirect Costs and Fees:** Calculates material handling, general and administrative (G&A) overhead, facilities cost of money (FCCM), and fixed fees or profits (capped where applicable, such as excluding fee calculations on direct equipment or cost-share arrangements). Proposers must fill out only unshaded/white cells, preserve the spreadsheet's structural columns, and ensure all subtasks are broken down by the performing organization to maintain transparency and budget accuracy.