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International Clinical Trials

The Right Message

Translating clinical trials documents accurately is essential when conducting multinational research trials. María Azqueta Arizcun at SeproTec explores how this can be achieved

When translating clinical trials documentation, such as patientreported outcomes (PROs) and patient informed consent forms (ICFs), it is essential to ensure high-quality standards that strictly adhere to regulatory guidelines. For these reasons, life science companies often employ in-country validators to provide industry-specific feedback to translation companies during the linguistic review of these types of document.

Since validation is not their primary job function, it is critical that the review process be made as easy and efficient as possible for the validators. However, it is in this validation process that many companies experience high costs and delays. Fortunately, there is a better way. With the right approach, companies can eliminate obstacles with validation while minimising the burdens the review process may pose to in-country validators. To this end, it is imperative to understand the importance of translation during the planning stage of a clinical research trial. During clinical research, a number of critical documents, including the investigator’s brochure, the clinical study protocol, subject information and the informed consent form, are typically translated. A poor translation may lead to adverse patient reactions and significantly delay the trial process, potentially delaying the entire project. This can ultimately cause a delay in getting the drug to market and result in the loss of a competitive advantage.

With a more seamless approach to integrating the workflow between ‘translation’ and ‘validation,’ all of these problems – and the costs associated with them – can be averted.


The FDA requires that international versions of PRO instruments are not just translated, but rather that they are equivalent in meaning to the original so that the validity of the responses is not affected. In addition to accurately translating the material, the documents should be adapted to the cultural context.

Bullinger et al contend, “culture and nations differ with regard to a more ethnological or political perspective.” Acquadro et al also state that communication between cultures depends on equivalence in thoughts and situations and not just equivalence in expressions (1). Nevertheless, similarity in thoughts and situations between cultures may not exist.

As a result of this potential disparity in meaning between cultures, achieving equivalence in health-related quality of life (HRQL) instruments is crucial to their use in cross-cultural research. It is yet to be determined how this can be achieved; however, several approaches have been developed to meet this challenge.


The main problems with translation are due to the manner in which various types of information are expressed in different languages. The goal of a translation is to ensure that the message remains the same regardless of the language in which it is expressed. The translator or translation team greatly affects not only the quality of the translation, but also the knowledge and interpretation of contexts in a different culture.

Language is a unique method of communication between culture and ethnic groups and, obviously, PRO documents gather data through language. When PRO instruments are created in a single language and then used in an international setting, they must be translated from one language to another, or even several others. This can be a highly subjective process.

As international collaboration continues and the use of PRO instruments in clinical trials, epidemiological investigations, and clinical practice expands, a greater need for international methods of measurement has developed.

Most instruments have been written in English, thus it is important to make sure that the same concepts are addressed in all languages when the instrument is used in international studies. This makes it possible to easily pool data and compare results across countries. The data must originate from ‘one instrument’ in order to have consistent international interpretation and analysis of results.

Worldwide regulators are concerned about the validity of many instruments that have already been translated for use in other countries. The European Agency for the Evaluation of Medicinal Products has expressed concern over whether health-related quality of life instruments are internationally validated. In order to adequately share and compare the results obtained across countries, the original instrument needs to undergo a process of linguistic validation that ensures that translations are:

  • Conceptually equivalent to the original instrument and to one another
  • Culturally relevant and acceptable to the target population within each target country
  • Psychometrically comparable (3)


The FDA’s guidance for industry document entitled, ‘Patient- Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims’ calls for translationrelated documentation of PRO documents to be provided to the FDA for review. It suggests PRO documentation should address the following topics:

  • The process used to translate and culturally adapt the instrument for populations that will use them in the trial
  • Description of patient testing, language- or culture-specific concerns, and rationale for decisions made to create new versions
  • Copies of translated or adapted versions
  • Evidence that content validity and other measurement properties are comparable between the original and new instruments (4)

In order to ensure that translations convey concepts in a similar way, several methodologies are employed. One such method is duplicate translation and harmonisation – this is when a translation is carried out by two different professionals and results are then compared and harmonised. Another method is backwards translation. This is a translation from the source language to the target language and then back from the target to the source; the resulting ‘back’ translation is then compared to the original to make sure that concepts have been properly translated.

However, the concept of back translation is not universally accepted by independent linguists, as it can lead to arguments about syntax and style choice; translation involves humans, and the results are not always consistent!


Translation companies often provide the initial translations, which are then validated by in-country personnel from the pharmaceutical or medical companies. These validators review the translated materials for final approval. Validators are not intended to work as translators, so the review process must be coordinated so as to make it efficient for them.

Companies often encounter challenges in the in-country validation phase, as there can be multiple rounds of revisions with their validators, creating extra steps in the translation review process, as well as unnecessary burdens for the validators, resulting in higher costs and time delays.

Subsequent rounds of revisions can be avoided by sending validators high-quality translations in the first review draft. To achieve this degree of quality, there are a number of pitfalls during the preparation process between validators and translators that should be avoided:

  • Unstated expectations
  • A lack of instructions that could lead to disparity in results. This is even more important when clinical trials will be performed in several countries. The translated documents need to be exactly equivalent; therefore, it is important to have the exact same criteria at the validation phase
  • No methodology in place to track comments and measure quality


In order to resolve quality control and workflow challenges, while adhering to all of the relevant regulations for accuracy, a process that would eliminate unnecessary rounds of revisions and delays during the validation phase needs to be employed. Such a process could work as follows:

Push Quality Upstream

Properly capturing nuances and conveying concepts is key to the quality of the translation, thus it is necessary to review source documents to identify initial potential issues. A team of translators should be built who are experts in the client’s field and the clinical trials document to be translated. They should also be familiar with regulations and the relevant national transpositions of those regulations. This is even more important when technical language needs to be conveyed in plain language for the patients involved in the clinical trial to fully understand the concepts. Translators should be provided with templates based on European Medicines Agency (EMA) or equivalent guidelines for terminology, structure and title translation to standardise review criteria and establish consistency across all countries.

Reach an Agreement

A consensus must be established on style and terminology early in the process. Terminology for the project needs to be developed and approved upfront to avoid differing opinions between translators and validators on ‘correct’ translations of key terminology. Test the translators using sample documentation and present it to the validators to ensure quality. This will ensure the validity of the process, comprehensiveness of instructions given to validators and upfront identification of potential issues with regards to how specific concepts are conveyed. A thorough review of the translation memories is usually required to address inconsistencies between them and the glossaries. Duplicate segments in translation memories and inconsistent translations need to be reviewed and corrected to guarantee top-quality input to translation.

Establish Clear Expectations

As reviewers are often tasked with more than translation validation, it is helpful to communicate expectations early on in order to avoid rushed translations or unexpected translation costs. It is also important to develop clear instructions on exactly what the validation entitles. Maximise E ciency Improve the overall project workfl ow through a process that facilitates ongoing client feedback, as well as the optimisation of the translator pool and translation memories.


When using in-country validators in the tran slation of clinical trials documents, three major steps need to be taken. First, agree upfront on terminology, instructions and expectations. Second, produce higher quality translations from the onset. Third, develop an ongoing process to incorporate validators’ feedback. This will ensure that project costs can be reduced without comprising quality.

Further reading

  1. International Society for Pharmacoeconomics and Outcomes Research,
  2. Linguistic Validation – Introduction – MAPI INSTITUTE,
  3. US Department of Health and Human Services, Food and Drug Administration, GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf

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María Azqueta Arizcun is Head of SeproTec’s translation department, and is responsible for the management and coordination of project managers, translators, software engineers and desktop publishing specialists. She holds a degree in Translation and Interpreting from the Universidad Europea of Madrid and is fl uent in Spanish, English, French and Italian. Email:
María Azqueta Arizcun
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