Animated little One2Treat Character

Combine patient voice and
clinical insights
to elevate the
full value of your treatment

Patient-centric clinical trial design and dose optimization through Net Treatment Benefit

One2Treat develops software solutions that help biopharmaceutical companies design, analyze and communicate clinical trials using Net Treatment Benefit (NTB), a patient-centric approach that integrates multiple clinically meaningful outcomes into a single treatment assessment.

By combing patient voice with clinical insights, sponsors can move beyond traditional endpoints and evaluate the totality of the evidence. As a result, treatments can be assessed across outcomes that matter most to patients, clinicians, regulators and payers.

By combining multiple prioritized criteria into a single primary endpoint, One2Treat helps:

  • Patient-centric clinical trial design based on Net Treatment Benefit
  • Capture and prioritize input from patients, clinicians, regulators and sponsors
  • Evaluate the totality of the evidence across efficacy, safety and quality of life
  • Support dose optimization strategies aligned with FDA Project Optimus
  • Reduce sample sizes and improve trial efficiency
  • Connect R&D through regulatory approval and market access

An already approved approach in multiple therapeutic areas, Consequently, sponsors can fully characterize treatment value and uncover clinically meaningful benefits that conventional analyses may overlook.

Experience a more holistic approach to clinical trial design and treatment evaluation through Net Treatment Benefit.

Net Treatment Benefit for Patient-Centric Clinical Trials


Net Treatment Benefit is a statistical framework that integrates multiple outcomes, including efficacy, safety and patient-centered measures, into a single treatment assessment.

By prioritizing outcomes according to stakeholder preferences, sponsors can design clinical trials that better reflect what matters most to patients while generating robust evidence for regulators and payers.


Dose Optimization for FDA’s Project Optimus


One2Treat supports dose optimization by quantifying the Net Treatment Benefit across efficacy, safety and tolerability outcomes.

This allows sponsors to compare doses holistically and identify dosing strategies that maximize patient benefit while aligning with FDA Project Optimus expectations.

Evaluating the Totality of the Evidence

Clinical trial results rarely tell a single story. One2Treat helps sponsors evaluate the totality of the evidence with a multi-dimensional assessment of treatment effect, integrating multiple treatment dimensions, including efficacy, safety, tolerability and patient experience.

This holistic assessment provides a more complete understanding of treatment value and supports regulatory, HTA and market access decisions.