Translation in Clinical Trials – All That You Need to Know
Clinical Trials save lives. Inaccurate Translation in Clinical Trials can do just the opposite. This is a plain and simple fact.
“Although the consequences of an inaccurate translation can be extremely serious in terms of human lives, credibility, and economic revenues, translation is often the last step in the planning of an international clinical trial, and it is rarely given the attention that it requires.”
If you are a Life Sciences company or a Clinical Research Organisation looking to perfect your processes and reach your global stakeholders effectively, this article will help you with just that. Here we will discuss everything that you need to know about translation in Clinical Trials. You will see what experts have to say.
Clinical Trials Save Lives
Let’s discuss the statement at the outset of this article: Clinical Trials save lives. Do they really? Here is an expert’s opinion on that:
“I’ve been a lung cancer doctor since 2000. When I started, the average survival of stage 4 lung cancer patients was 8 to 9 months. Now, the average survival is 20 to 22 months, with an average survival of more than 3 years in some subsets of lung cancer patients. We’re still working toward better outcomes, but thanks to clinical trials, it’s almost three times better than what it was 20 years ago.”
The importance of clinical trial research cannot be overemphasised. The objective of every clinical trial is to collect enough evidence to prove that the drug or the treatment under question is safe and effective. This objective can be summed up in these three questions crucial to every clinical trial:
Does a drug/method of treatment work?
Does it work better than other options?
Does it have any side effects?
Getting to the answer to these questions involves the most important aspect of the trial: people.
Importance of Including Different Demographics in Clinical Trials
Different people react differently to different medicines. Although this statement seems to oversimplify the complex issue and the raging battle on the issue of why diverse representation matters in clinical trials, it is the honest fact. Demographic data refers to factors like age, race, and sex, but for the purpose of this article, we will talk about the importance of factoring race into clinical trials.
A Cautionary Tale:
Warfarin, an oral anticoagulant commonly used to treat and prevent blood clots. An adverse side effect of this drug was found to be excessive bleeding and incorrect dosing could even lead to death. Let’s see the relevance of diversity in this context. Here is an excerpt of the case study:
“The therapeutic requirements for warfarin differ by the presence of these specific genetic variants, and their frequencies vary substantially across genetic ancestries. For example, populations with greater genetic African ancestry are more likely to require higher average daily doses of warfarin (about 6 mg per day), whereas populations with greater genetic Asian ancestry require lower average warfarin doses (about 3.4 mg per day).
However, because most of the early genetic studies of warfarin were conducted in populations with predominantly European ancestry, dosing algorithms failed to adequately generalize to the diverse U.S. population. Indeed, even though warfarin has been approved for human use since 1951, it was not until 2013 that it was learned that genotype-guided dosing would be of clinical utility.”
Life Sciences companies and CROs have been receiving quite a bit of backlash for failing to include diverse groups in their clinical trials. The obvious solution then is to widen the diversity and thus narrow health disparity. Which brings us to the crux of the article: translation of Clinical Trials.
The Importance of Accurate Translation in Clinical Trials
With globalisation becoming more relevant than ever before and the push to increase diversity in clinical trials, the call of action has become to reach a greater mix of people – the more diverse the better. This brings with it obvious benefits, as well as unique challenges.
Language is one of the most important factors to consider in this regard. There would be little use in sawing through red tape, spending huge budgets, and picking through all the nitty gritty, if you aren’t able to reach – both literally and figuratively – the people (subjects) of the clinical trial.
Is this an exaggeration? Not in the least. An article put it brilliantly:
“Faulty translations may entail the ‘failure of the participant to act as instructed, disparities in prescription and administration of the study preparation, and reduced likelihood for appropriate followup and treatment of the underlying conditions and/or of side effects of the trial,’ (Eldar and Wexler 2009: 15), not to mention physical or emotional damage, misconduct of the experiment, time, and money.”
The stakes are definitely high. Accurate translation is vital and can be a matter of life and death.
What is Involved in the Translation of Clinical Trials
The documents that need translating when it comes to clinical trials can range from legal business documents to patient consent forms, instruction manuals etc. Here are some of the documents that will need to be translated:
Investigator’s Manual
Clinical Study Reports
Case Report Forms
Drug Registration Documentation
Clinical Study Protocol
Adverse Event Source Documents
Development Safety Update Reports
Informed Consent Forms
Every document is unique. For example, a clinical trial protocol is a formal document with highly technical content and should be translated with accuracy. It can often also include administrative language, statistics and more which are not strictly medical. An informed consent form, while being accurate, should also be translated in a way that is easily understood by the subject who will need to sign the document.
Steps to Ensure Quality Translation for Your Clinical Trials
Recognising the importance of translation to the success of your clinical trials is the first step. Now let’s talk about what you can do to ensure the quality of the translation.
Step 1: Find a Translation Partner who specialises in Clinical Trials
Subject matter expertise is key when it comes to translating documents for clinical trials. The partner should have significant experience in the field and be familiar with the nuances of translating these documents. Using a single language service provider (LSP) who has the resources to translate to all the languages you need will help you maintain a consistent brand voice and also ensure ease of business.
Step 2: Create a Terminology Base
This is one of the most important steps in ensuring consistency in translation across all documents included in a clinical trial. Create a glossary of all important terms, labels, names etc that are pertinent to the trial and then get this base document translated into the different languages you need. This will become the cornerstone from which translators can work.
Step 3: Recognise Cultural Differences
Cultural sensitivities can affect how people respond to the trial, their participation, and also the efficacy of the trial itself. Using native translators to check for cultural anomalies and report it can help minimise faux pas that could derail your trial.
Step 4: Check, Check, Check
As tempting as it might be to cut costs with a translation only process, remember that there is no shortcut to quality. Ask for a TREV (Translation and Review) process. This includes translation, proofreading, reconciliation, and quality checks. Going through the translation by multiple linguists and a quality assurance team will help you avoid the pain of inaccurate translations and costly lawsuits.
What to Look for in a Translation Partner
Let’s get to the first and most crucial step: Finding the right Language Service Provide who can be the one stop shop for all your language needs. Doing this right will save you a world of pain when it comes to navigating the many challenges of dealing with multiple countries, languages, and cultures. Here are a few important questions that you need to ask when selecting a translation partner:
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Check if they are ISO 17100 certified. The ISO 17100:2015 provides requirements for the core processes, resources, and other aspects necessary for the delivery of a quality translation service that meets applicable specifications. It specifies requirements for all aspects of the translation process directly affecting the quality and delivery of translation services. It includes provisions for translation service providers concerning the management of core processes, minimum qualification requirements for translators and revisers, the availability and management of resources, and other actions necessary for the delivery of a quality translation service.
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Get an insight into their recruitment process. What qualifications do they require from their translators. Ideally, the more rigorous the process, the better the quality of translators. Ideally, a translator on their team should have the following qualifications:
• Native speaker of the target language
• Fluent in the source language
• Significant translation experience with subject matter
• Verifiable client references with a good recommendation
• A bachelor’s degree (or equivalent) or higher
• Translation certification in the designated language pair (from a professional translation body .
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As we have discussed, documents related to clinical trials require more than just medical knowledge. To be the right fit requires knowledge of technical aspects of the clinical trial and approved terminology, an understanding of the comprehension and background of the target audience, a strong grasp of local sensitivities and culture, and the drive to go beyond words and make the text clear, natural, and accurate. This calls for a rare combination of professional translation skills and biomedical knowledge.
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This is a crucial question. A good translation partner does more than play middleman between linguists and the client. They will have a documented and time-tested quality assurance process to ensure that their deliverables are error-free and print-ready. While you’re at it, get their Complaints Procedure, Invoice Management, and other details that you need to gain evidence of their competence and to ensure that your interaction with them is easy and streamlined.
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Translation for Clinical Trials – Get it Right!
Translation is a crucial part of the Clinical Trial process and must be treated as such. As an ISO 17100 certified translation company that specialises in Clinical Trials, we are passionate about getting it right for our clients. With over a decade of experience in clinical trial translation and with over 2000 linguists, we have served clients from all over the world in more than 350 languages. Reach out to us and let’s get talking about how we can help you with your translation needs.