# Post-marketing safety monitoring stratified by ancestry and sex, with label updates

Source: https://onco.cc/ideas/idea-tr1-post-marketing-safety-by-ancestry-and-sex/  
OnCo record `idea-tr1-post-marketing-safety-by-ancestry-and-sex` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Once a drug is in wide use, real-world records could be checked routinely for whether side effects differ by ancestry or sex, since trials were too small in those groups to notice. Findings would go into the label.

## Summary

Regulators run active pharmacovigilance on linked EHR, claims and registry data for new oncology drugs, pre-specifying analyses of serious adverse events and discontinuation by self-reported race, genetic ancestry where available, and sex, with a defined signal threshold that triggers label review. Sentinel-type systems exist in the US and EU but rarely stratify this way.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Stratified surveillance will detect subgroup-specific toxicity signals for several agents within three years of approval that were not visible in pivotal trials, leading to label changes.
- Rationale: Under-enrolment means subgroup safety is unknown at approval; real-world use quickly generates the numbers, but only if the analysis is planned.
- Proposed test: Apply stratified surveillance to the ten most-used oncology drugs approved in the last five years and count actionable signals.
- Maturity: speculative
- Actor: regulator

## Sources

- Bottleneck evidence (Trials do not represent the people who get cancer): Loree et al., Disparity of race reporting and representation in trials leading to cancer drug approvals (JAMA Oncology 2019): https://doi.org/10.1001/jamaoncol.2019.1870

## Connected records

- terms: [Immune-related adverse events (irAEs)](https://onco.cc/terms/irae/), [Real-world evidence](https://onco.cc/terms/real-world-evidence/)
- bottlenecks: [Trials do not represent the people who get cancer](https://onco.cc/bottlenecks/b-trial-diversity/), [Weak real-world evidence and registries](https://onco.cc/bottlenecks/b-real-world-evidence/)
- key papers: [Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018](https://onco.cc/key-papers/paper-loree-jama-oncol/)

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