Clinical trials are crucial for developing and testing new treatments and therapies for various medical conditions. They are designed to determine the safety and efficacy of new drugs and medical devices in real-world settings. In addition, these trials help to identify potential side effects and risks associated with specific interventions. Without clinical trials, guaranteeing safe and effective treatments would not be possible.
In the past, clinical trials were held in the same country where new treatments originated. Today, this isn’t always the case. GlobalData reports that of the trials planned for 2022 (as of May 15, 2022), the Asia-Pacific (APAC) region accounted for the majority of clinical trials, with 54%, followed by North America (27%) and Europe (20%).
In recent years, pharmaceutical companies have started conducting more clinical trials in developing countries. The principal reasons are lower operational costs and an increased patient pool. While beneficial, running trials in different parts of the world poses communication challenges. It’s even more complex when you consider that trial participants and researchers often come from diverse countries and cultures.
To overcome language difficulties, accurate clinical trial translations are essential. They ensure all participants receive the same level of information and care, leading to more successful outcomes.
The significance of accurate translations in clinical research cannot be emphasized enough. Any errors in translating clinical documents can result in loss of life and/or legal consequences.
Improving Quality and Safety in Clinical Trials through Accurate Translations
The key benefits of clinical research translations are that they:
- Ensure correct interpretation of the study methods and results
- Help to avoid errors, misunderstandings and misinterpretations that can lead to adverse events, incorrect diagnoses and inappropriate treatments
- Assure consistency in study protocols and patient data across different languages and cultural contexts
- Help ensure regulatory compliance and adherence to ethical standards in different countries
- Enhance the credibility and validity of the research findings, reducing the risk of publication bias, fraud or invalidation
- Facilitate clear communication and collaboration between researchers, sponsors and stakeholders from different linguistic and cultural backgrounds
- Help improve patient safety and quality of care by ensuring medical instructions and informed consent forms are accurate and understandable for everyone involved
- Reduce costs and delays associated with redoing translations or correcting errors in the translation process.
Raising the Bar: Best Practices for High-Quality Translation of Clinical Trials
By adhering to best practices for clinical research translations, researchers can help ensure their trials are successful and safe. The following five are indispensable.
Work with a Team of Subject Matter Experts
Clinical trial translations require working with subject matter experts such as medical doctors and regulatory professionals. They possess in-depth knowledge of their respective industries and a strong understanding of the technical language used in research.
Clinical research translations are not just about converting words from one language to another. There is a need to interpret idiomatic expressions, jargon and technical terms that may have a different equivalent in the target language.
With subject matter experts on board, you ensure the right terminology is used and accurately convey any nuances. As a result, the final document/research paper will be reliable and of the highest quality.
Ensure Compliance with Regulatory Requirements
Complying with all regulatory requirements when conducting clinical trial translations is paramount. This includes adhering to guidelines and regulations set by regulatory bodies such as:
- The Food and Drug Administration (FDA) in the United States
- The European Medicines Agency (EMA) in Europe
- The World Health Organization (WHO)
- The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- Local governmental entities
- Local institutional review boards (IRBs).
Compliance with regulations ensures that translating all trial-related materials (such as consent forms, patient information sheets and case report forms) meets the necessary quality standards and accurately conveys the relevant information.
Therefore, it is essential to work with a clinical trial translation service that is well-versed in the regulatory requirements of different countries.
Follow a Standardized Translation Process
A standardized process refers to a set of established procedures followed consistently in a particular task or project. This process involves several key steps, such as a thorough review of the source text, selection of qualified translators and use of translation software, glossaries and style guides.
In clinical research translations, having a standardized process helps avoid confusion and ensures that all study documents are consistent and accurate.
Utilize Linguistic Validation for Quality Assurance
Developing new medicines and medical devices requires a thorough understanding of patient experiences. This can be achieved through patient-reported outcomes (PROs), typically interviews, surveys or questionnaires. The information they provide is invaluable for the success of clinical trials. Therefore, PRO documents and materials must be translated accurately to leave no room for misinterpretation. This is where linguistic validation comes in.
It involves the rigorous and systematic testing of a questionnaire or other instrument across multiple languages and cultures. This is achieved through several steps, including:
- Two or more translators translating the source content into two translated versions
- Reconciling these translations into a single version
- Editing
- Back translation
- Comparing back translation with the source material to spot discrepancies
- Clinical review
- Cognitive debriefing – a focus group of native speakers from the target country evaluates the translation
- Final revision.
Linguistic validation is essential for ensuring that the data collected from clinical trials are valid, reliable and comparable across different languages and cultures.
Consider Cultural Differences and Regional Variations
Cultural differences such as language barriers, beliefs and customs must be considered to accurately communicate any trial’s objectives, procedures and results.
Regional variations also play a vital role in translating clinical trials as healthcare systems and medical practices differ from one region to another. A thorough understanding of the local regulations, norms and ethics is essential to ensure the study is conducted properly. It is also necessary to consider the socio-economic, political and demographic factors affecting the participants’ perception of the trial.
Failure to consider cultural differences and regional variations may result in inaccurate data, low participant retention rates or ethical violations.
An example:
A study on diagnosing clinical depression in elderly patients in Malaysia reported that a question in the questionnaire had no discriminative power in identifying depression cases. It asked: “Do you prefer to stay home rather than going out and doing new things?”
The problem with the question is that in Malaysia, family living is prioritized over an individual lifestyle. Consequently, patients gave a positive response, despite their depression.
Final Thoughts
Clinical trials have gone global and are now being conducted across more diverse countries than ever before.
To ensure they’re understandable to everyone involved, all aspects need to be translated and localized according to the following best practices:
- Work with subject matter specialists
- Ensure compliance with regulatory requirements
- Follow a standardized translation process
- Use linguistic validation for quality assurance
- Consider cultural differences and regional variations
The best way to ensure best practices are followed is to engage respected clinical trial translation services.
From Language Barriers to Breakthroughs: How EC Innovations Can Help You
For more than 26 years, EC Innovations has been a trusted partner of leading companies in medicine and the clinical trial industries.
Our vast expertise spans pre-clinical studies, clinical trial phases, regulatory submissions and pharmacovigilance. We provide translation services for clinical trial materials that include but are not limited to:
- Study protocols
- Protocol synopses
- Informed consent forms
- Investigator brochures
- Patient records
- Clinical study reports
- Case report forms
- Ethics committee submissions
- SUSAR
We have a dedicated Life Sciences division composed of subject matter experts, qualified translators, editors, proofreaders and a quality assurance reviewer.
Don’t take any chances with inaccurate clinical trial translations – trust EC Innovations’ clinical trial translation service for accurate results.
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Want to know more about the exceptional quality assurance we provide for clinical trial translation at EC Innovations? Contact us today!