OnCo
ideasIdea

Drop the 'must speak English' rule: translated consent and questionnaires as standard

Many trials quietly exclude people who do not speak the local language because consent forms and questionnaires exist only in that language. Providing translations and interpreters for the commonest languages would fix this.

Protocols may not exclude on language; sponsors provide certified translations of consent and patient-reported outcome instruments in the languages spoken by at least 5 percent of the catchment population (with linguistically validated PRO versions), and fund professional interpreters for visits. Validated translations of common PRO instruments already exist for dozens of languages.

Hypothesis
Removing language exclusions and funding translations will increase enrolment of non-native-speaking patients to their share of the catchment population and will not reduce PRO completion rates.
Rationale
Language exclusions are common and rarely justified scientifically; PRO instruments have validated versions in many languages, so the cost is coordination rather than development.
What would test it
Audit a sample of protocols for language exclusions; sponsor pilot removing them at multilingual sites and compare enrolment by language.
Maturity
early clinical
Who has to act
industry
Cost to try
Small (under $1M)
Years to first evidence
1
Bottlenecks it attacks

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