What are Clinical Trials?
According to the World Health Organization (WHO), a clinical trial is a research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Nowadays, clinical trials constitute an integral part of medical products’ discovery and development.
Clinical Trials and Translation
Translation plays a significant role during the launching and conduction of a clinical trial. In this blog post, we examine the challenges that clinical trial documents pose from a language perspective to companies in the life science industry and translators.
Documents usually Translated for Clinical Trial Research
- Investigator’s Manual
- Clinical Study Protocol
- Clinical Study Reports
- Case Report Forms
- Adverse Event Source Documents
- Data Sheets
- Development Safety Update Reports
- Drug Registration Documentation
- Informed Consent Forms
Key Factors When Translating Clinical Trial Documents
Understanding your Audience
A large portion of clinical trial documents is meant for physicians and researchers but participants are also key stakeholders in each study; in fact, recruiting participants requires providing information in their native language.
Technical writers and translators should recognize the different reading levels, cultural backgrounds, and degrees of technical comprehension of each group. Participant-facing material such as information sheets is more engaging if it isn’t packed with complicated legal or scientific jargon and is translated using a clear style that reads authentically in the target language.
Beyond Medical Content
Not every document in clinical trial research features technical content such as medical or pharmacological information. Some documents also include content related to the study logistics, statistics, and legal requirements.
Managing Terminology Consistently
Clinical trials are at the forefront of the medical world and it often happens that there are no established translations for some concepts being developed in a particular study. Similarly, certain terms do not have correspondences in the target language and need to be further explained or culturally adapted to make sense. Figuring out how to manage terminology efficiently ensures consistency and accuracy.
Making your Translations Bulletproof
Mistakes in the translation of clinical trial documents cause damage to a company’s credibility, but also to human lives. Poor translations could mean “the failure of the participant to act as instructed, disparities in prescription and administration of the study preparation, and reduced likelihood for appropriate follow-up and treatment of the underlying conditions and/or of side effects of the trial” (Eldar and Wexler, 2009).
For this reason, quality assurance combines automated quality checks (done with computer-assisted technology) and standardized workflows that allow reviewers to provide meaningful feedback about the translation.
Ethics Committees (ECs) and Institutional Review Boards (IRBs) may ask for back translations when trials are particularly risky or if there is a need to guarantee that there is no loss of meaning during the translation process.
Back translations add to the quality assurance efforts but managing the process effectively requires specific know-how. Back translations will not match the original document word-for-word and reviewers have to validate if the intended meaning of the source text is captured in the translation, or whether it requires changes.
Handling Project Updates with Ease
What happens if a researcher introduces changes to protocols during the course of the study? Spotting changes in a 20,000-word document can be extremely challenging if you do not use the right technology or do not have the required technical knowledge. But if you know your way around CAT tools, you can introduce proper project versioning and compare the new documents against the segments stored in the translation memory. This way, tracking changes and getting your translations updated becomes less painful.
Ocean Translations has been serving companies in the life sciences industry for more than 20 years. We are an ISO 9001 certified language partner that support the localization efforts of numerous pharmaceutical, healthcare, and medical device firms.