# Real-world dose intensity and toxicity monitoring to revise labelled doses

Source: https://onco.cc/ideas/idea-data-real-world-dose-intensity/  
OnCo record `idea-data-real-world-dose-intensity` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Track how much of each cancer drug patients actually receive and how often they need to reduce it, and use that to change the official dose when the label is too high.

## Summary

Oncology drugs are often labelled at doses most patients cannot tolerate; dose reductions in practice are common but invisible to regulators. Project Optimus addresses dose selection before approval; nothing systematic addresses it after. The proposal uses structured prescribing data to publish real-world dose intensity, reduction rates and toxicity per drug annually, with a regulatory pathway to update labels when the real-world modal dose differs from the label.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Systematic real-world dose monitoring will identify at least ten approved oncology drugs where more than half of patients are dose-reduced, and label revision or randomised dose-optimisation trials will follow for a majority of them.
- Rationale: Post-marketing dose changes (for example for several kinase inhibitors and ADCs) have happened only after years of ad hoc reports; structured data would surface the problem in months.
- Proposed test: Compute dose-intensity metrics for the 30 most-used oral targeted agents in one national prescribing dataset; publish; track subsequent label or guideline changes over three years.
- Maturity: early-clinical
- Actor: regulator

## Sources

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

## Connected records

- fronts: [AI & Computation](https://onco.cc/fronts/ai-computation/)
- terms: [Real-world evidence](https://onco.cc/terms/real-world-evidence/)
- bottlenecks: [Toxicity and quality of life are undervalued](https://onco.cc/bottlenecks/b-toxicity-qol/), [Weak real-world evidence and registries](https://onco.cc/bottlenecks/b-real-world-evidence/), [Wrong doses](https://onco.cc/bottlenecks/b-dose-optimisation/)

---
JSON: https://onco.cc/api/v1/entities/idea-data-real-world-dose-intensity.json