The clinical trial process for medical drugs can take up to two decades and cost over $1 billion. Translating clinical trial information and results can be a challenging, but vital, component of the process. In order to translate clinical trial materials successfully, it is important to understand the requirements and potential pitfalls.
Overview of Clinical Trials
Clinical trials are broken down into phases, as summarized in the following table:
|Phase||Goal||Dose||# of Participants||Success Rate|
|Pre-clinical||Drug testing in non-human subjects to gather efficacy, toxicity, and pharmacokinetic information||Unrestricted||N/A||Varies|
|Phase I||Drug testing on healthy volunteers for dose-ranging||Sub-therapeutic with ascending doses||20-100 healthy volunteers (or cancer patients for cancer drugs)||Approx. 70%|
|Phase II||Drug testing on patients with medical conditions to assess efficacy and side effects||Therapeutic dose||100 - 300 patients with specific medical conditions||Approx. 33%|
|Phase III||Drug testing on patients with medical conditions to assess efficacy and safety||Therapeutic dose||300 - 3,000 patients with specific medical conditions||25-30%|
|Phase IV||Post-marketing surveillance (monitor drug use by public)||Therapeutic dose||Anyone seeking treatment from physicians||N/A|
Due to the high cost of clinical trials, pharmaceutical, biotechnology, and medical device companies have started outsourcing their clinical trials to Contract Research Organizations (CROs). Some CROs serve all phases of the clinical trial process, whereas other CROs focus on a specific phase.
According to OutsourcingPharma.com, the global CRO market was worth $27 billion in 2014, and is expected to grow at an annual rate of 6% over the next 6 years. One driving force behind this growth is outsourcing of clinical trials. North America houses the largest share of the CRO market, followed by Europe. Asia-Pacific is the fastest growing region for CRO activity.
Outsourcing clinical trials requires complying with regulatory requirements, approval processes, and medical conduct in the respective countries where CROs operate. This means documents such as clinical summary reports, investigator brochures, and patient informed consent forms may need to be translated by medical translators into local languages. Medical translation requires far higher attention to detail than other types of translation, as people’s health and lives are at risk. In other words, outsourcing clinical trials requires impeccable medical translation.
Medical translation, however, presents several challenges to medical translators. Below, we explore some of the challenges faced by medical translators when translating for clinical trials.
Medical Translation Challenges
1. Target Audience: Layperson or Medical Professional?
Medical content is generally meant either for patients or medical professionals. The type of terminology and phrases used in medical texts depends on the target audience. Therefore, when carrying out medical translations for clinical trials, medical translators must carefully consider the target audience (layperson or medical) in order to determine the appropriate terminology and phrases in the target language. For example, the medical terms “hypotension”, “myalgia”, and “tinnitus” are defined in layperson terms as “low blood pressure”, “muscle ache”, and “ringing in the ears”, respectively.
For a table of English medical terms and their layperson definitions, click here.
2. Euphemisms, Medical Eponyms, Acronyms, and Synonyms
The medical world is full of euphemisms - mild or indirect expressions used in place of harsher or blunter expressions, or in reference to something unpleasant, awkward, or difficult to talk about. For medical translation, it is important to keep in mind that euphemisms in other languages may be completely different from their English counterparts. For example, euphemisms for death vary greatly across languages, as shown in the table below:
|Language||Euphemism(s) for Death||Literal English Definition|
"to pass away"
"to go peacefully"
"to not make it"
"to do everything we (doctors) could"
"to no longer be with us"
"Avaler son extrait de naissance"
"Fermer son parapluie"
To swallow one's birth certificalte
To close one's umbrella
"De pijp uitgaan"
To get out of the pipe
"Estirar la pata"
To stretch one's leg
|Japanese||"他界する" ("Takai suru")||To move to another world|
Medical eponyms – diseases or medical conditions that are named after people – are regularly seen in the medical field. For example, in English, Lou Gehrig’s disease is the eponym for “motor neurone disease” or “amyotrophic lateral sclerosis.” In French, the disease is called “maladie de Charcot” in layperson terms and “sclérose latérale amyotrophique” in medical terms. Bottom line - both the layperson’s and the medical terminology for medical conditions in other languages can be entirely different.
Acronyms – abbreviations formed from the initial letters of other words – are frequently used in medical workspaces, including clinical trial facilities. For example, the English medical acronym “ALS” for Amyotrophic Lateral Sclerosis (medical term for Lou Gehrig’s disease) becomes “SLA” when translated into French, because the French medical term for Lou Gehrig’s disease is “Sclérose Latérale Amyotrophique.” So, medical translators should use acronyms for medical terms in the target language only after the accuracy of the medical term and the existence its acronym in the target language are confirmed.
Synonyms – words having the same or similar meaning as other words – are also common. For example, in English, “diarrhea” has the following synonyms: “dysentery”, “flux”, “food poisoning” and “the runs” – some which are medical terms, and others which are colloquial or slang terms. However, the word for diarrhea in other languages may have completely different synonyms in those languages.
3. Medical Drugs: Brand Name AND Chemical Name
Medical translation becomes slightly complicated when dealing with translation of medical drug names. For example, aspirin (common medical drug for pain, fever, and inflammation) translates to “aspirine” in French. These, however, are just the brand names of this drug, and say nothing about the chemical composition of the drug. The chemical name for aspirin is “acetylsalicylic acid”, or “l’acide acetylsalicylique” in French. So, for target audiences in other countries, it does not suffice to translate only the brand name of medical drugs. BOTH the brand name AND chemical name of medical drugs should be translated so that target audiences are clear about the chemicals in the drugs they consume.
To say the least, medical translators need to be extremely mindful of their target audience, the various euphemisms, medical eponyms, acronyms, and synonyms that exist in the target language, and the chemical names in target languages that correspond to medical drugs. Medical translation for outsourcing clinical trials is no easy business, but the end result is cost savings for pharmaceutical, biotechnology, and medical device companies and easier introduction of successfully tested drugs into local marketplaces.
Want to learn about how localization service providers (LSPs) overcome the hurdles of medical translation? Join SimulTrans’ Margarita Núñez at the Outsourcing in Clinical Trials Europe 2017 conference, stay tuned for part two of this blog “Tackling Medical Translation for Outsourcing Clinical Trials,” or schedule a free consultation with us by clicking the link below.