# Make sponsors justify every trial exclusion of older and multimorbid patients

Source: https://onco.cc/ideas/idea-acc-broad-eligibility-as-regulatory-default/  
OnCo record `idea-acc-broad-eligibility-as-regulatory-default` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Most cancer patients are over 65 and a large share have other illnesses, yet trials routinely exclude them on organ function, prior cancers, HIV or brain metastases. Regulators should require sponsors to justify each exclusion, include patients with controlled comorbidities by default, drop upper age limits, and report enrolment over 75 in labels.

## Summary

ASCO and Friends of Cancer Research published recommendations to broaden eligibility (organ function thresholds, prior malignancies, HIV, brain metastases) and the FDA issued guidance, but uptake in industry protocols is partial. A regulatory requirement that each eligibility exclusion be justified in the protocol, with default inclusion of patients with controlled comorbidities and no upper age limit, would shift the baseline. Enrolment of patients over 75 should be reported in labels.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Protocols under a justification requirement will enrol at least twice the proportion of patients over 75 and with significant comorbidity, with no material change in trial timelines.
- Rationale: Exclusions are copied between protocols by habit rather than evidence; making them costly to include changes the default.
- Proposed test: Compare age and comorbidity distributions in registration trials submitted before and after the requirement, and correlate with post-marketing safety signals.
- Maturity: early-clinical
- Actor: regulator

## Sources

- Bottleneck evidence (Older and multimorbid patients are excluded and undertreated): Mohile et al., Evaluation of geriatric assessment and management on toxic effects of cancer treatment (GAP70+, Lancet 2021): https://doi.org/10.1016/S0140-6736(21)01789-X

## Connected records

- terms: [Accelerated approval](https://onco.cc/terms/accelerated-approval/)
- bottlenecks: [Older and multimorbid patients are excluded and undertreated](https://onco.cc/bottlenecks/b-aging-comorbidity/), [Trial design, endpoints and cost](https://onco.cc/bottlenecks/b-trial-design/), [Trials do not represent the people who get cancer](https://onco.cc/bottlenecks/b-trial-diversity/)

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