One2Treat provides software that helps biopharmaceutical companies design, analyze, and communicate clinical trials using Net Treatment Benefit (NTB), a patient-centric statistical framework. The platform integrates efficacy, safety, tolerability, and quality-of-life outcomes into a single treatment assessment, supporting dose optimization aligned with FDA Project Optimus and regulatory submissions. Its tools, One2Treat Insights and One2Treat Voice, enable holistic evidence evaluation from trial design through market access.
Funding
Funding not disclosed
Founders
Product
Problem
Traditional clinical trial analyses evaluate efficacy and safety outcomes separately, making it difficult for sponsors to understand the overall treatment effect and to capture what matters most to patients, clinicians, regulators, and payers. This fragmented approach complicates benefit-risk assessment, dose optimization, and communication of treatment value across the product lifecycle.
Solution
One2Treat provides software solutions that enable biopharmaceutical companies to design, analyze, and communicate clinical trials using Net Treatment Benefit (NTB), a patient-centric statistical framework that integrates multiple clinically meaningful outcomes into a single treatment assessment. The platform leverages Generalized Pairwise Comparisons (GPC), a hierarchical statistical method that compares every patient in the experimental arm with every patient in the control arm according to a predefined hierarchy of outcomes. By prioritizing outcomes according to stakeholder preferences, One2Treat allows sponsors to evaluate the totality of the evidence across efficacy, safety, tolerability, and quality of life, supporting more efficient trials and robust regulatory submissions. The platform also helps sponsors compare doses holistically, aligning with FDA Project Optimus expectations and supporting HTA and market access decisions through a multi-dimensional assessment of treatment value.
Target Audience
Primary customers are biopharmaceutical companies and clinical research sponsors seeking patient-centric clinical trial design, dose optimization, and benefit-risk assessments that align with regulatory expectations, including FDA Project Optimus guidance.
Features
- One2Treat Insights enables simultaneous analysis of multiple clinical outcomes using Net Treatment Benefit and Generalized Pairwise Comparisons, providing a multidimensional assessment of treatment effect
- One2Treat Voice supports systematic capture and prioritization of patient, clinician, regulator, and sponsor preferences to formalize outcome hierarchies within a single statistical framework
- Supports dose optimization strategies aligned with FDA Project Optimus by quantifying Net Treatment Benefit across efficacy, safety, and tolerability outcomes
- Enables evaluation of hierarchical composite endpoints (HCEs) where multiple clinical outcomes are combined according to prespecified clinical importance
- Reduces sample sizes and improves trial efficiency through patient-centric endpoint design
- Connects R&D through regulatory approval and market access by generating evidence that supports decision-making across the product lifecycle