# A 'dose evidence' panel in every label: how many doses were tested, and how

Source: https://onco.cc/ideas/idea-tr1-dose-evidence-statement-in-label/  
OnCo record `idea-tr1-dose-evidence-statement-in-label` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A drug's label should say whether its dose was chosen by comparing several doses or simply by finding the most patients could tolerate. Doctors could then know how much room there is to reduce the dose safely.

## Summary

Labels and public assessment reports include a standard panel: doses tested in humans, whether randomised dose comparison was done, the exposure-response basis, the fraction of pivotal-trial patients who required dose reduction, and any post-approval dose studies. The panel is machine-readable and aggregated publicly.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Making dose evidence visible will increase sponsor investment in dose optimisation before approval and will increase clinician willingness to use evidence-based dose reductions where the panel shows a flat exposure-response.
- Rationale: Clinicians currently cannot tell whether a label dose is optimised or merely tolerated; transparency in other regulated domains (nutrition, energy labelling) changed both producer and consumer behaviour.
- Proposed test: Introduce the panel; survey oncologists' dose-reduction decisions for agents with and without evidence of dose optimisation, and track dose-optimisation content in submissions over five years.
- Maturity: speculative
- Actor: regulator

## Sources

- FDA Oncology Center of Excellence: Project Optimus: https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus

## Connected records

- collections: [FDA Oncology Approvals (OCE) & Novel Drug Approvals](https://onco.cc/collections/fda-approvals/)
- bottlenecks: [Knowledge reaches practice too slowly](https://onco.cc/bottlenecks/b-knowledge-diffusion/), [Wrong doses](https://onco.cc/bottlenecks/b-dose-optimisation/)

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