Default-inclusive eligibility: sponsors must… · Idea

Regulators and ethics committees would require a one-line scientific or safety justification for each exclusion criterion, with a default set of permitted criteria (the ASCO-Friends of Cancer Research broadened criteria on brain metastases, organ function, prior malignancies, HIV and hepatitis) needing no justification and anything stricter needing one. The FDA's 2020 eligibility guidances describe what is reasonable; this idea makes the reasonable set the default and puts the burden of proof on restriction.

Hypothesis

Protocols written under a justify-every-exclusion rule will have at least a third fewer exclusion criteria and a measurably higher fraction of real-world patients eligible (as simulated against a real-world oncology dataset), without an increase in grade 5 adverse events attributable to the broadened population.

Rationale

Analyses of protocol eligibility against real-world data show that many criteria are copied from earlier protocols and that relaxing them changes the eligible pool substantially with little effect on the estimated hazard ratio. Ethics review already asks for justification of risk; asking for justification of exclusion is symmetric and cheap.

Proposed test

A cooperative group or single regulator pilots the rule for 12 months on all new phase 2/3 oncology protocols, comparing criterion counts, simulated eligible fraction and later serious-adverse-event rates against the prior year's protocols.

Maturity

early clinical

Who acts

regulator

Cost to try

Small (under $1M)

Years to first evidence

2

Bottlenecks it attacks

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.
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.

Notes

Protocol upgrade, graded proven but unevenly used. Applying common strict laboratory and performance-status cut-offs to 235,234 United States patients receiving systemic therapy left 48 per cent eligible; broadened criteria increased the eligible number by 78 per cent, most for older, female, Black and lower-income patients, and those eligible only under the broader criteria had shorter real-world survival (hazard ratio 1.31), which trials would need to account for (Kaur, 2024).
Adoption gap, as measured for one criterion: among 3,077 United States trials in advanced breast, colorectal, lung cancer and melanoma from 2012 to 2022, the share that did not exclude patients with brain metastases rose from 11.5 to 17.3 per cent after the 2017 ASCO, Friends of Cancer Research and FDA recommendations, while wholesale exclusion did not change (7.5 against 6.2 per cent) (Xiao, 2024).

Key papers

1

observationalJournal of Clinical Oncology 2017406 citations

Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement

One bottleneck page on OnCo cites this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing page listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.

Connected

9

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Default-inclusive eligibility: sponsors must justify every exclusion criterion

Notes

Key papers

Connected

Similar pages

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Default-inclusive eligibility: sponsors must justify every exclusion criterion

Notes

Key papers

Connected

Similar pages

institutions

terms

roadmaps

ideas

collections

bottlenecks

key papers

Sources

Default-inclusive eligibility: sponsors must justify every exclusion criterion

Overview

Notes

Key papers

Connected

Similar pages

institutions

terms

roadmaps

ideas

collections

bottlenecks

key papers

Sources

Default-inclusive eligibility: sponsors must justify every exclusion criterion

Overview

Notes

Key papers

Connected

Similar pages

institutions

terms

roadmaps

ideas

collections

bottlenecks

key papers

Sources