Budgeting a multilingual document set

Translation budgets depend on the documents and languages required, the time and review each version needs, and the consequences of leaving material untranslated. Limited resources call for priorities based on patient need and risk.

Translation volume and quality control

Small and medium-sized device manufacturers were reported in 2020 to underestimate translation time and cost, the task of finding a provider and the need to verify translated versions through back-translation or other quality-control systems. ¹

A regulatory document set may contain relatively little local-language material: one writer working in France estimated that at least 80%, perhaps 90%, of the regulatory documents received were in English, with French exceptions including investigator protocols and patient consent forms. ² Most of the other documents went to multiple European Union states, the US Food and Drug Administration or other countries. ²

Trial language planning should account for dialect differences within countries or regions, translation of consent forms, assessments and dosing instructions, validation of translated assessments and case-report-form free text that may lack literal equivalents. ^{3, 4} The scale can be substantial: for one COVID-19 vaccine trial, a language-services provider translated English into six South African languages and four Philippine dialects while meeting national and transnational deadlines. ⁵

Timing and the cost of delay

Translation should be built into trial planning rather than commissioned as an afterthought. ^{6, 7} Repeated source revisions can delay commissioning until recruitment should already have begun, shrinking a country's recruitment window until it is abandoned as unviable. ⁷ Integrating translation into existing workflows allows timelines to be anticipated and can often avoid last-minute rushes. ⁷

Estimates cited in 2024 put trial dropout at about 30% of recruited patients, with roughly 40% of dropouts avoidable and replacement costing nearly three times initial recruitment. ⁵ In one survey, 35% of dropouts cited difficulty understanding as their main reason for leaving, while clear expectations and explanations of importance were among the reasons for continuing. ⁵ Quality translation can support retention by keeping participants informed and engaged throughout the study. ⁵

Allocation of limited resources

A five-part approach recommended in 2025 balances quality, cost and efficiency when full multilingual provision is not immediately feasible. ^{8, 9, 10, 11, 12}

1. Prioritise high-impact materials. Focus first on documents directly affecting care and compliance, including consent forms, discharge instructions, emergency-department signage and medication guides. Begin with core materials and expand according to patient needs, risks and funding if full translation is not feasible.
2. Optimise workflows. Allow time for review, quality assurance and regulatory checks; standardise departmental processes to avoid duplication; and appoint project managers to oversee requests, terminology and timely delivery.
3. Develop reusable assets. Prepare approved multilingual templates for common materials such as appointment reminders, discharge instructions and medication guides; structure content into reusable modules; and maintain an updated terminology glossary.
4. Use artificial intelligence (AI) with human oversight. AI can accelerate high-volume work and reduce costs, but human editing remains essential for medical accuracy and cultural appropriateness. Invest in full professional human translation for high-priority patient-safety materials, consent forms and emergency guidance; use AI-assisted translation with human post-editing for moderate-priority patient education and general healthcare guidance; and consider AI with minimal human review for low-priority internal or administrative documents, where it may suffice.
5. Monitor and adjust. Track patient satisfaction, miscommunication incidents and compliance; identify frequently used materials and remaining language gaps; and revisit the strategy to maintain cost-efficiency and accessibility.

^{8, 9, 10, 11, 12}