# Kidney and liver impairment dosing studies completed before approval, not years after

Source: https://onco.cc/ideas/idea-tr1-organ-impairment-pk-before-approval/  
OnCo record `idea-tr1-organ-impairment-pk-before-approval` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Dosing advice for people with weak kidneys or liver is often missing at approval and added years later, if ever. Requiring those studies before approval would protect a large group of real-world patients from day one.

## Summary

Regulators require dedicated or population-PK-based organ impairment dosing recommendations (mild, moderate and, where feasible, severe renal and hepatic impairment) as part of the initial marketing application for oncology drugs, rather than as post-marketing commitments, using sparse PK from broadened-eligibility trials and small dedicated cohorts. Ties to relaxing organ-function eligibility criteria.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Drugs approved with organ-impairment dosing will show lower toxicity-related hospitalisation among patients with impairment in real-world data than drugs approved without, and post-marketing commitments for these studies will fall.
- Rationale: Organ impairment is common in cancer patients and clinicians either extrapolate or withhold drugs; post-marketing studies are frequently delayed or never completed.
- Proposed test: Audit completion times of organ-impairment post-marketing commitments for the last decade of oncology approvals; then require them pre-approval for three years and compare real-world outcomes in impaired patients.
- Maturity: speculative
- Actor: regulator

## Sources

- Bottleneck evidence (Wrong doses): FDA Oncology Center of Excellence, Project Optimus: https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus

## Connected records

- cancers: [Hepatocellular carcinoma](https://onco.cc/cancers/hcc/), [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/), [Renal cell carcinoma](https://onco.cc/cancers/rcc/)
- bottlenecks: [Older and multimorbid patients are excluded and undertreated](https://onco.cc/bottlenecks/b-aging-comorbidity/), [Trials enrol too few, too slowly](https://onco.cc/bottlenecks/b-trial-enrolment/), [Wrong doses](https://onco.cc/bottlenecks/b-dose-optimisation/)

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