5 Common Translation Requirements For Clinical Trials

5 Common Translation Requirements For Clinical Trials

In recent years, the need for clinical trials of new drugs and treatments has increased around the world.

According to a 2021 report from Grand View Research, the global clinical trials market was worth an estimated 44.3 billion USD in 2020 and is expected to expand at a compound annual growth rate of 5.7% from 2021 to 2028. In other words, the market for clinical trials is growing at an unprecedented rate. 

In today’s globalized world, the Life Science complex meets new challenges working and connecting with cultures worldwide. Truly understanding one another across the industry becomes paramount in any clinical study, where stakes are usually much higher.

Accurate translations are indispensable in clinical trials, but the importance of medical translation comes from more than just the need to render words into a different language. Wondering why?

In this post, we’ll explain the most common translation requirements for clinical trials. But first, we discuss why the translation of clinical trials is vital.

Let’s dive in.

Quick Recap What Are Clinical Trials

Quick Recap: What Are Clinical Trials?

To start with, let’s briefly define what clinical trials consist of.

According to the World Health Organization (WHO), clinical trials are a type of clinical research that studies new tests and treatments, evaluating their effects on human health.

Some clinical trials seek new ways to detect, diagnose, or assess the course of a disease. Other research, on the other hand, also aims to prevent the onset of a disease.

A third type of clinical trial takes place when pharmaceutical firms develop a new drug, research underway, and begin the application phase. Two examples are cancer cure treatments and the clinical research for Covid-19 vaccines. These studies are carried out with the help of human volunteers and are supervised by health research organizations and ethics committees.

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Why Clinical Trial Translation Matters

Medical translation is one of the most highly demanded sub-disciplines within life science translation. Medical translation covers all dimensions of medicine as a discipline, as an industry, and as a service. Therefore, it’s made up of several specialties, from clinical trial translation to the translation of medical devices and manuals.

Clinical research has become an important source of employment and economic growth. Translators haven’t remained on the sidelines, since these activities generate a vast volume of documentation, many of which must be translated, at one stage or another, in the clinical trial process. 

Bearing this in mind, we can say that clinical trial translation is vital for three reasons:

  • More volunteers. By translating clinical trials documents, especially the informed consent forms, research teams can reach wider audiences to increase the number of potential volunteers to take part in a study. 
  • Informed consent. When Clinical Research Organizations (CROs) work with volunteers from other countries, properly translating forms and protocols is an ethical obligation. For volunteers to be able to provide informed consent, crucial information shouldn’t be lost in translation.
  • International academia. The translation of clinical trial protocols, as well as research results, allows information to be shared beyond borders. Furthermore, it enables researchers from different countries to work together. 

But, considering the complexity of the healthcare sector, what are the translation requirements to be accomplished?

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Our medical report translation cheat sheet is for you.

5 Translation Requirements for Clinical Trials

A proper clinical trial translation must satisfy the regulations and standards of medical translation, thanks to the expertise of the language professionals involved.

If you are in the search of a top-rated specialized translation company, these are the key translation requirements for clinical trials that you should keep in mind. We also call them pillars of life sciences translation:

5 Translation Requirements for Clinical Trials

1. Accurate Communication and Interpretation of Clinical Trials

Translators must possess subject-matter expertise and proficient management of specific industry terminology. So when dealing with research, clinical trials, and medical reports, translation services rely on translators with an extensive medical background.
.  Subject-matter expertise. To ensure successful international clinical trials translation, knowledge in the medical field becomes a necessity. Only field-specialist translators have the competence and capabilities to deal with the intricacies of medical texts with precision and meticulous attention to detail.

.  Specific terminology. The quality of clinical trials translation hinges on the accuracy and consistency of its specific terminology. Both accuracy and consistency are essential; one never goes without the other. This is only possible through the powerful synergy between expert medical translators and advanced translation tools such as glossaries and terminology bases.

Specialized translators have a flair for research and are always updated about new developments in the medical field. This is how they incorporate new terminology into their glossaries. For example, since the emergence of Covid-19, words such as “asymptomatic” or “incubation period” have come to more notoriety. 

2. Regulatory Insight

The difference between medical translation and other types of translation is the normative compliance that rules the procedure. The medical field is extensively restricted by local, national, and international regulations. The reason is justified, as clinical trials contain sensitive content that might put lives and businesses at stake.

For data to be reliable, clinical research protocols must conform to the standards of several regulatory bodies. These include: 

  • The European Union
  • The European Medicines Agency (EMA)
  • World Health Organization
  • Food and Drug Administration (FDA) 
  • Countries national regulations
  • International Conference on Harmonization (ICH) 
  • Local Institutional Review Boards (IRBs).

These bodies, to ensure the accuracy of test data translation, uphold their own translation rules. 

At present, international regulations continue to demand the highest quality. In late January 2022, the Clinical Trials Regulation (CTR) will come into force, which will seek to improve clinical trial processes across the EU by implementing the use of the EU’s Clinical Trials Information System (CTIS).  EMA will also maintain the CTIS.

The use of CTIS, with its constantly updated database, will provide the industry with tools to achieve more efficient results. But, at the same time, it will be a challenge for those who have to submit information through CTIS, as clinical trials will have to meet the highest standards.

In this regard, CROs and life science companies can’t do without clinical trial translation agencies. An ideal translation partner with in-depth knowledge of the CTIS and other regulations, advanced technology infrastructure, and expert resources can offer the right support in terms of quality standards and adherence to deadlines.

Clinical trial translations are often disregarded or left to the last minute. However, the consequences of an inaccurate translation in a field as sensitive as the clinical one can damage the lives of many people, diminish the research credibility and represent huge economic costs. 

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3. Cultural Aspects

As medical translation concerns patients, clear communication is crucial. In this matter, professional healthcare translators make sure to adapt the material so it can meet the cultural and contextual nuances of the target audience. For clinical trials translation, seasoned linguistic skills and profound cultural knowledge are indispensable.

But, why do we mention cultural context in the healthcare field? Literal translations can be word-to-word accurate but lack the insight of cultural and behavioral subtleties. Therefore, your target audience can miss important details about the procedures, which can compromise the whole project and ultimately risk patients’ lives.

In medical trials’ translations, readability is of the utmost importance. Particularly in the case of informed consent forms patients fill before participating. For instance, in some cultures, personal questions may be invasive and the volunteer may feel reluctant to answer them. 

And with that in mind, a skilled translation company puts careful consideration into the target audience’s nuances in each country to provide a first-class technical translation that’s relevant and convenient to them.

4. Proper Translation Technology

Combining translator efforts with proper translation tools is the ultimate formula for a successful clinical trial translation. To that end, Language Service Providers offer their services where medical expertise and technological advancement come together.

When first dealing with vast amounts of content, machine translation comes in handy, allowing translators to concentrate on final details and accuracy. But in that case, human intervention is imperative to refine and sharpen up the end results. 

Other technologies used to provide a consistent translation of clinical trials include translation memories, computer-assisted translation (CAT) tools, and glossaries.

Automatization in translation provides faster turnaround times, even considering the lexical complexity of healthcare matters. Constantly updating translation memories and other resources with new terminology is key so the translation company’s automation tools don’t become deprecated.

Medical translation tools

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5. Solid Quality Assurance & Linguistic Validation

The quality assurance process involves not only translation, editing, and proofreading, but also full linguistic validation

Linguistic Validation is a process where the translation of an instrument or a patient questionnaire is exhaustively tested for reliability, conceptual equivalence, and cultural adaptation. Full linguistic validation is a key requirement in the clinical trial translation process to harmonize the translation and single out any mistakes or omissions that might cause miscommunication or confusion and ultimately disrupt the clinical trial. The steps in this process are:

The Clinical Trial Translation Process

Before starting the linguistic validation process, the translatability assessment is necessary. This evaluation is used to avoid ambiguities in the source text and to anticipate future problems that may appear during the linguistic validation process. 

In the second step, at least two translators translate independently the source clinical documents into the target language (and then compare the results).

A linguist then analyzes the two translation versions against the source text and reconciles them to produce a single version that combines the best of both.

In this step, the linguist edits the reconciled version ensuring that the results reflect the source text and the translation is flawless, free of ambiguities and errors.

Once edited, this reconciled version is back translated into the source language. Back translations are usually independently performed by at least two translators.

In clinical translation, back translation is a step that should not be skipped, as it is often required by ethics committees and institutional review boards. The accuracy provided by this step safeguards patients from receiving erroneous information due to mistranslation.

In the comparative stage, the back translation is compared to the original source text. Once the results are presented, the linguistic team involved meets to eliminate any discrepancies that affect the original meaning of the source text. 

The proofreading team is responsible for delivering the final version of the translation to begin linguistic validation. 

The linguistic validation is performed through a clinician revision and/or cognitive debriefing.

Initially, the final version is reviewed by a clinician expert in the specific subject matter. Their participation in the process is extremely important to determine possible edits or clarifications in the translation of the report.

Nevertheless, cognitive debriefing is the pilot test of linguistic validation. This step is performed by means of focus groups in the target country, who are asked to read and evaluate the final version of the document based on their educational, economic, and background level. In some instances, cognitive debriefing is performed on a single person.

The final version is reviewed by the direct translation team and the back translation team, based on the results obtained through the clinician review and/or cognitive debriefing. Then, a quality assurance team ensures that the final output accurately conveys the source text.

Translation of clinical trials cannot be done without linguistic validation. In clinical trial translation services, linguistic validation overcomes the most common technical and medical translation challenges and ensures the utmost quality and relevance of your multilingual clinical trials. It’s the most effective option that will guarantee that your medical translations meet the required standards.

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How to Pick an Effective Medical Language Partner

Are you interested in a clinical trial translation? If so, always remember to work with a company that has a solid team of subject-matter experts and offers effective and competent translation services.

At bayantech, we provide cutting-edge language solutions for a wide variety of industries, medical translation included. Our highly qualified and constantly trained team of professionals consists of editors, native-language proofreaders, and translators, who pay attention to every aspect of your clinical trial translation project to ensure extremely high quality and accuracy.

We fully comply with ISO 9001:2015 and 17100:2015 certification standards, as well as industry-leading confidentiality practices.

Two decades working with healthcare leaders (in the MENA industry and beyond) have turned us into a specialized medical translation team that can help you overcome almost any language challenge.

So, are you interested in a clinical trial translation? We are the answer.

Get a Clinical Trial Translation Quote Today

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