{"entity":{"id":"b-trial-diversity","kind":"bottleneck","name":"Trials do not represent the people who get cancer","aka":[],"tldr":"Older, Black, Hispanic, Asian, rural, poor and multimorbid patients are under-represented, so results may not apply to them.","summary":"Trials that lead to cancer drug approvals enrol predominantly younger, white, fitter patients treated at academic centres in a handful of high-income countries. In pivotal trials supporting US approvals from 2008 to 2018, Black patients made up about 3% and Hispanic patients about 6% of participants, and race was not even reported in a large share of trials; patients over 65 have been under-represented for decades relative to their share of incidence. Pharmacogenomic differences (for example, in DPYD, UGT1A1 and EGFR mutation prevalence), differences in comorbidity, body composition and social context all mean that efficacy and toxicity can differ, and the evidence to know does not exist. The geographic concentration also means most of the world's patients are treated on the basis of trials in populations unlike them. Regulators now require diversity action plans, but enforcement, infrastructure and trust are the real constraints.","asOf":"2026-09-08","links":[{"label":"Loree et al., Disparity of race reporting and representation in trials leading to cancer drug approvals (JAMA Oncology 2019)","url":"https://doi.org/10.1001/jamaoncol.2019.1870"},{"label":"FDA Oncology Center of Excellence, Project Equity (archived copy)","url":"https://web.archive.org/web/20240415200043/https://www.fda.gov/about-fda/oncology-center-excellence/project-equity"},{"label":"Hutchins et al., Underrepresentation of patients 65 years of age or older in cancer-treatment trials (NEJM 1999)","url":"https://doi.org/10.1056/NEJM199912303412706"}],"tags":[],"related":["fda-approvals","clinicaltrials-gov","idea-tr1-diversity-plans-with-consequences","idea-tr1-ancestry-aware-pharmacology-programme","idea-tr1-duffy-null-neutrophil-threshold","idea-tr1-mandatory-older-adult-cohort","idea-tr1-parallel-comorbidity-cohorts","idea-tr1-lmic-sites-in-pivotal-trials","idea-tr1-community-health-worker-recruitment","idea-tr1-language-access-in-trials","idea-tr1-site-equity-index","idea-tr1-include-pregnancy-capable-people-sensibly","idea-tr1-age-floor-twelve-for-adult-trials","idea-tr1-sex-stratified-pk-and-dosing","idea-tr1-disability-and-mental-illness-inclusion","idea-tr1-representativeness-in-the-label","idea-tr1-diverse-investigator-pipeline","idea-tr1-paid-community-advisory-boards","idea-tr1-post-marketing-safety-by-ancestry-and-sex","idea-tr1-ecog-2-dedicated-cohorts","idea-tr1-trial-desert-map"],"cancers":["prostate","multiple-myeloma","tnbc","nsclc","hcc","gastric"],"sections":[],"technologies":["geriatric-assessment","ai-trial-matching"],"targets":[],"drugs":[],"companies":["swog","ecog-acrin","hengrui","akeso","beone"],"institutions":["nci","asco","sysucc","tata-memorial","cams-cancer-hospital"],"pathways":[],"terms":["egfr-exon19-l858r","hazard-ratio"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-loree-jama-oncol","paper-hutchins-n-engl-j-med"],"journals":[],"dependsOn":[],"notes":[],"stage":"trials","severity":"major","metrics":[{"label":"Black and Hispanic participants in trials supporting FDA cancer drug approvals 2008-2018","value":"3.1% and 6.1%","source":"Loree et al., JAMA Oncology 2019","url":"https://doi.org/10.1001/jamaoncol.2019.1870"},{"label":"Patients aged 65 or older in SWOG treatment trials 1993-1996 vs their share of US cancer incidence","value":"25% vs 63%","source":"Hutchins et al., NEJM 1999","url":"https://doi.org/10.1056/NEJM199912303412706"},{"label":"Share of genome-wide association study participants of European ancestry (2016)","value":"81%","source":"Popejoy & Fullerton, Nature 2016","url":"https://doi.org/10.1038/538161a"}],"causes":["Trial sites are concentrated at academic centres in wealthy areas and countries.","Eligibility criteria on organ function, comorbidity and performance status disproportionately exclude older and minority patients.","Historical abuses and present-day experiences of discrimination reduce trust in research.","Costs of participation (travel, time off work, childcare) are highest for poorer patients.","Sponsors face no penalty for unrepresentative enrolment and prefer fast accrual at established sites."],"currentEfforts":["The Food and Drug Omnibus Reform Act (2022) requires Diversity Action Plans for pivotal trials, with FDA draft guidance issued in 2024.","FDA Project Equity in the Oncology Center of Excellence coordinates representation in oncology trials.","The ASCO-ACCC initiative provides site self-assessment and Just ASK implicit-bias training to increase enrolment of under-represented groups.","NIH policy on inclusion across the lifespan (2019) removed age-based exclusions from NIH-funded trials.","NCORP places NCI trials in minority and underserved community sites.","Asian and Chinese cooperative groups and companies (Hengrui, Akeso, BeOne) now run registrational trials in Asian populations, changing the geographic mix of evidence."],"successLooksLike":"Enrolment in pivotal trials matches the age, ancestry and geographic distribution of the disease within a few percentage points, and subgroup data are sufficient to detect clinically meaningful differences in efficacy or toxicity."},"route":"/bottlenecks/b-trial-diversity/","neighbours":{"collection":[{"id":"clinicaltrials-gov","kind":"collection","name":"ClinicalTrials.gov","route":"/collections/clinicaltrials-gov/"},{"id":"fda-approvals","kind":"collection","name":"FDA Oncology Approvals (OCE) & Novel Drug Approvals","route":"/collections/fda-approvals/"}],"idea":[{"id":"idea-moon-global-open-trials-os","kind":"idea","name":"A global open trials operating system any hospital can plug into","route":"/ideas/idea-moon-global-open-trials-os/"},{"id":"idea-moon-literacy-first-design-standard","kind":"idea","name":"A health-literacy certification standard for oncology portals, letters and apps","route":"/ideas/idea-moon-literacy-first-design-standard/"},{"id":"idea-tr1-mandatory-older-adult-cohort","kind":"idea","name":"A mandatory over-70s cohort with geriatric assessment in 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