{"entity":{"id":"idea-tr1-diversity-plans-with-consequences","kind":"idea","name":"Diversity action plans with consequences: unmet targets trigger post-approval requirements","aka":[],"tldr":"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.","asOf":"2026-09-08","links":[{"label":"FDA: Clinical trial diversity (archived copy)","url":"https://web.archive.org/web/20250201021950/https://www.fda.gov/consumers/minority-health-and-health-equity/clinical-trial-diversity"},{"label":"FDA Drug Trials Snapshots","url":"https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots"}],"tags":[],"related":["fda-approvals"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["nci"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-trial-diversity"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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.","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","cost":"small","horizonYears":3},"route":"/ideas/idea-tr1-diversity-plans-with-consequences/","neighbours":{"collection":[{"id":"fda-approvals","kind":"collection","name":"FDA Oncology Approvals (OCE) & Novel Drug Approvals","route":"/collections/fda-approvals/"}],"institution":[{"id":"nci","kind":"institution","name":"National Cancer Institute (NIH)","route":"/institutions/nci/"}],"bottleneck":[{"id":"b-trial-diversity","kind":"bottleneck","name":"Trials do not represent the people who get cancer","route":"/bottlenecks/b-trial-diversity/"}],"roadmap":[{"id":"trial-modernisation-roadmap","kind":"roadmap","name":"Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on","route":"/roadmaps/trial-modernisation-roadmap/"}]}}