04 Dec The hidden cost of poor medical translation in international studies

In a multinational clinical trial, it is enough for a single sentence to be poorly translated for the whole study to falter: misinformed patients, invalid data, regulatory delays running into millions of dollars. Medical and pharmaceutical translation is no longer an “extra,” but a central component of patient safety and the project’s economic viability.

Medical and pharmaceutical translation as a pillar of international trials

In international studies, practically everything goes through translation: protocols, informed consents, patient diaries, recruitment materials, labels, reports for ethics and regulatory committees and even the translation of medical articles that provide scientific support to the project.

In the United States, the FDA requires that informed consent forms be in the participants’ language and that translated versions of essential documents be part of the regulatory documentation.

In Europe, the Clinical Trials Regulation (Regulation (EU) No. 536/2014) makes it mandatory to ensure that the information provided to patients is understandable in their language and culturally appropriate. Translating “more or less well” is not an option: agencies expect robust processes of translation, revision and, in many cases, linguistic validation.

When translation fails: risk to the patient and the data

Several studies have demonstrated that communication errors in healthcare have real clinical consequences. Research on interpretation in consultations has shown significant percentages of errors in information transmission and some of these have moderate to high clinical relevance.

Evidence also indicates that the use of qualified professionals significantly reduces errors with potential clinical impact, improves adherence and health outcomes and reduces readmissions and unnecessary tests.

The rise of machine translation adds another layer of risk. Recent evaluations of machine translation tools in medical contexts have detected terminological and semantic errors that, if applied without human supervision, could lead to erroneous patient recommendations.

In the context of a clinical trial, this can translate into:

• Patients who believe they are complying with the protocol when they are not.
• Misinterpreted dosage or administration guidelines.
• Quality of life questionnaire items that are understood differently depending on the language version.

The result: biased data between countries, loss of comparability and risk of the study not being acceptable to the authorities.

The economic impact: delays, rework and trials in the air

Clinical trials are already expensive: it is estimated that the vast majority suffer delays, with many of these delays lasting more than a month. Each day of delay can cost hundreds of thousands or even millions of euros, depending on the phase and scale of the study.

Poor medical translation can contribute to these delays in several ways:

• Review and retranslation of informed consents and patient materials based on observations from the ethics committee or regulatory agency.
• Reconsenting patients if it is considered that they did not receive adequate information in their language.
• Data unusable due to linguistic discrepancies between questionnaire versions or poorly adapted PRO scales.

What seemed like a budget saving (choosing the cheapest option or relying on machine translation without expert post-editing) ends up becoming cost overruns for validation, additional data collection and trial extensions.

Reputational, legal and regulatory costs

The damage is not just financial. Regulatory agencies can issue warning letters, require corrections, delay approvals or, in extreme cases, demand the withdrawal of applications if they deem that the translated documentation does not meet the clarity and accuracy requirements for the patient.

In addition, there have been documented cases in which translation errors in medical instructions have been associated with lawsuits, significant financial compensation and reputational damage for hospitals and pharmaceutical companies.

In a context where public and regulatory trust is key, a bad translation ceases to be a technical failure and becomes a strategic risk.

Best practices in the translation of medical articles and documentation

“Certified medical translation” is not just an aesthetic seal: in many contexts, a Certificate of Translation is mandatory for regulatory documents and materials aimed at patients.

Some key practices to minimise risks:

• Work with teams specialising in medical and pharmaceutical translation, familiar with FDA, EMA and ICH guidelines, as well as the terminology of each therapeutic area.
• Apply linguistic validation processes for PROs and questionnaires: direct and reverse translation, reconciliation, review by clinical experts and cognitive interviews with patients.
• Centralise translation memories and glossaries to ensure consistency between countries, avoiding divergences in key concepts (adverse events, inclusion/exclusion criteria, safety terminology).
• Integrate translation from the study design stage, not at the end, to reduce rework and potential regulatory observations.
• Ensure secure and traceable workflows, with platforms that allow version control, approvals and auditing of every change in terminology.

The same logic applies to the translation of medical articles derived from the trial: if results are published with terminological inconsistencies between languages, scientific credibility suffers.

The hidden cost of poor medical translation manifests itself on three fronts: reduced patient safety, less reliable data and more fragile budgets. In the face of this, investing in certified medical translation and robust medical and pharmaceutical translation processes is a way to protect the study, the brand and, above all, the people involved.