ideasIdea
Remove blanket exclusions for mental illness and dementia; support consent instead
People with serious mental illness or dementia are routinely excluded from cancer trials, though they get cancer just as often and do worse. Supported consent and reasonable accommodations would let many take part.
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.
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.
What would test it
Audit exclusion language in current protocols; pilot the replacement criteria at psychiatric-liaison-supported cancer centres and measure enrolment and deviation rates.
Maturity
speculative
Who has to act
industry
Cost to try
Small (under $1M)
Years to first evidence
2
Bottlenecks it attacks
- Trials do not represent the people who get cancer · Older, Black, Hispanic, Asian, rural, poor and multimorbid patients are under-represented, so results may not apply to them.
- Trials enrol too few, too slowly · Fewer than one in ten adults with cancer joins a trial. Trials close for lack of patients, not lack of ideas.