# Diversity action plans with consequences: unmet targets trigger post-approval requirements

Source: https://onco.cc/ideas/idea-tr1-diversity-plans-with-consequences/  
OnCo record `idea-tr1-diversity-plans-with-consequences` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Companies now have to file a plan for enrolling a representative mix of patients. If the trial misses the plan, the label should say so and the company should be required to fill the gap after approval.

## Summary

Under the US FDORA requirement for diversity action plans, sponsors set enrolment goals by race, ethnicity, sex and age. The proposal adds teeth: the approved label states enrolled demographics against disease incidence; shortfalls beyond a threshold trigger a post-marketing requirement for a supplementary study or registry in the under-enrolled group with a deadline; and repeat shortfalls are published in an annual sponsor scorecard.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Attaching label statements and post-marketing requirements to missed diversity targets will raise representativeness of pivotal trials, measured by participation-to-prevalence ratios in FDA Drug Trials Snapshots, within five years.
- Rationale: Goals without consequences have not moved enrolment demographics much over two decades. Post-marketing requirements are an existing, enforceable instrument.
- Proposed test: Compare participation-to-prevalence ratios for approvals before and after enforcement begins, and track completion of triggered post-marketing studies.
- Maturity: being-tested-at-scale
- Actor: regulator

## Sources

- FDA: Clinical trial diversity (archived copy): https://web.archive.org/web/20250201021950/https://www.fda.gov/consumers/minority-health-and-health-equity/clinical-trial-diversity
- FDA Drug Trials Snapshots: https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots

## Connected records

- collections: [FDA Oncology Approvals (OCE) & Novel Drug Approvals](https://onco.cc/collections/fda-approvals/)
- institutions: [National Cancer Institute (NIH)](https://onco.cc/institutions/nci/)
- bottlenecks: [Trials do not represent the people who get cancer](https://onco.cc/bottlenecks/b-trial-diversity/)
- roadmaps: [Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on](https://onco.cc/roadmaps/trial-modernisation-roadmap/)

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