{"entity":{"id":"idea-tr1-disability-and-mental-illness-inclusion","kind":"idea","name":"Remove blanket exclusions for mental illness and dementia; support consent instead","aka":[],"tldr":"People with serious mental illness or dementia are routinely excluded from cancer trials by vague compliance clauses, though they get cancer just as often and do worse. Replacing those clauses with assessable criteria, and funding supported consent and accommodations such as longer visits, would let them take part.","summary":"Protocols replace 'psychiatric illness that would interfere with compliance' and similar clauses with specific, assessable criteria; supported decision-making, legally authorised representative consent where appropriate, and accommodations (longer visits, carer involvement, simplified materials) are funded. Enrolment and outcomes for these groups are reported.","asOf":"2026-09-08","links":[{"label":"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)","url":"https://doi.org/10.1001/jamaoncol.2019.1870"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["nci"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-trial-diversity","b-trial-enrolment"],"keyPapers":["paper-loree-jama-oncol"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Removing blanket exclusions with supported consent will enrol patients with psychiatric or cognitive conditions at a rate closer to their prevalence among cancer patients without increased protocol deviations attributable to the condition.","rationale":"People with serious mental illness have higher cancer mortality and are near-absent from trials; the exclusion is habitual, not evidence-based. Dementia trials show supported consent works.","test":"Audit exclusion language in current protocols; pilot the replacement criteria at psychiatric-liaison-supported cancer centres and measure enrolment and deviation rates.","maturity":"speculative","actor":"industry","cost":"small","horizonYears":2},"route":"/ideas/idea-tr1-disability-and-mental-illness-inclusion/","neighbours":{"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/"},{"id":"b-trial-enrolment","kind":"bottleneck","name":"Trials enrol too few, too slowly","route":"/bottlenecks/b-trial-enrolment/"}],"paper":[{"id":"paper-loree-jama-oncol","kind":"paper","name":"Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018","route":"/key-papers/paper-loree-jama-oncol/"}]}}