Electronic Health Reporter

In this, the day and age of the global coronavirus outbreak, the job of the medical translator and interpreter has never been more relevant. Resolving this global crisis involves a great deal of research and analysis, much of it in the form of clinical trials. All of the requisite research and analysis must not only be reported and published but accurately documented as well. Once all of the research from the clinical trials has been completed, the information must be made readily available.

The document translation must be completed by certified medical translators and disseminated globally in order for the research to be relevant and helpful. This is an absolutely crucial role during any medically related global crisis but the medical translation of the clinical trial documentation will ultimately be the key to bringing the COVID-19 global pandemic to a successful conclusion before it can get any worse for the people of the world.

In tandem with the need for medical translation is the localization of clinical trials, which requires additional paperwork that the medical translator must make accessible to the world.

Document Requirements for Domestic and International

According to the National Institute of Health, “One of the most common inspection findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. This also happens to be the most common pitfall identified during sponsor audits. The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data.”

One of the biggest concerns during the current global medical crisis is that many of the clinical trials will not be properly published at all. Of those that are, many will suffer due to the improper documentation and document recordings, and all this before medical document translation begins. Among the biggest culprits of under-reporting, clinical trials were many academic institutions where certified medical translators should be readily available, and clinical trial document requirements should not be a challenge.

A study from the US Food and Drug Administration which is responsible for the oversight and investigation of Clinical Trials in the United States, inadequate documentation records were one of the top causes of clinical trials being brought into question or having them dismissed completely.

Clinical Trial Audits were most commonly required according to the FDA because of the following reasons:

1. failure to follow the investigational plan   (34%)
2. inadequately informed consent form         (28%)
3. inadequate/inaccurate records                 (27%)

The amount of documentation required to conduct a clinical trial is overwhelming on the best of days. Every one of the documents is absolutely relevant to the successful conclusion of the clinical trials being conducted by medical researchers.

This is especially true in terms of the current global Covid-19 pandemic. In terms of global clinical trials, translation services should work in support of the global effort, though this also requires that all of the documentation is in order, to begin with. Further, it relies on medical researchers working with a certified medical translation agency that also has the capacity to integrate and implement successful localization strategies to ensure the accuracy of the medical translations before they are distributed globally.

Clinical Trials and Why Localization Services Matter

As of the twenty-third of March, 2020, the US National Library of Medicine’s Clinical Trials database reports that only 5% of the current clinical trials underway are international from their standing. However, 49% of the ongoing clinical trials are wholly outside of US jurisdiction, and a good many of them may, in fact, be international in nature and still require both medical translators and medical interpreters. It should also be noted, however, that given the large number of foreigners living in some locations, that even many domestic clinical trials will still require quality translation and interpretation services.

• Non-U.S. Clinical Trials   164,712   (49%)
• S. only Clinical Trials              112,640                (34%)
• International Clinical Trials 17,336                (5%)
• Location Not provided              39,318                  (12%)
• Total 334,006               (100%)

The document requirements for clinical trials are challenging for the best of days. These challenges are then made worse during times like the current global COVID-19 pandemic when a larger percentage of international clinical trials will take place and not only medical translation and localization services will be required, but document management will be made even more challenging. This leads to an introduction of transcreation services, or more generally, translation utilizing multiple localization strategies.

The translation company or the translation provider should have a strong understanding, not only of the local language but the local culture, as well. For medical interpreters, this may mean having a woman there to interpret for female patients given any local cultural restrictions. In some cases, this may be due to the need to translate Latin to English or even Latin translation into the local vernacular or into specific medical terms given the frequent use of the original Latin words within the field of medical research.

Any poorly translated document, no matter how seemingly inconsequential, can result in the entire clinical study being invalidated, or worse still, having to be redone at a great cost. Again, during the current global epidemic, there can be no room for such errors. According to agencies like the World Health Organization and the FDA, there are additional concerns with the documentation, though largely in regards to the data storage and the dissemination of the information collected during clinical trials. It looks as if blockchain solutions may be among the most efficient means of addressing the actual data management required for clinical studies.

Clinical Trials and Localization in Medical Translation Services

Localization services are expanded in terms of clinical trials and research as opposed to the more traditional or standard medical translation services provided for medical document translations. In terms of the organization conducting the clinical trials, localization generally refers to locations where costs may be mitigated. This is evidenced in a report by the Italian National Health Council discussing the localization process for clinical trials to be conducted throughout Europe. This, however, is not the extent of localization strategies in terms of clinical trials and medical translation and interpretation services.

Language localization is equally important throughout the entire process of the clinical trials, especially in terms of clinical trials being conducted internationally during events such as the current global coronavirus pandemic. In the case of the current global medical crisis, all of the medical documentation directly related to the individual participants of the clinical trials must reflect a keen understanding of the local variations of the mother language in addition to the local vernacular and very specific medical terminology, all in addition to a keen understanding of the local culture and any potential cultural taboos or restrictions.

These diverse requirements necessitate a very nuanced linguistic and personal understanding of both the local people and their local culture. Much of the work involved in an international clinical trial may require a doctor to patient interpreting services. Both the medical translator and interpreter must be intimately familiar with how matters are addressed, especially when dealing with people that may have certain cultural sensitivities. Like legal translators, medical translators need to be able to describe each and every detail with precision in terms of the medical language, treatment, prevention, and cures.

However, when speaking with the people, these translation specialists must also understand any local idioms, expressions or other languages that may be used by the patient. Only in this way will they be able to translate not only the literal lexical meaning of what is said but the more nuanced meaning behind such expressions. At the same time, it is important to understand the cultural environment as well, to prevent giving offense and risk the potential harm to the individual participant as well as to the ongoing clinical trials.

How Do I Become a Medical Translator and Can I Work Specifically In Clinical Trials

There is no master accreditation organization that oversees all of the medical translators and interpreters in the world. While there are no global standards in terms of certification for medical translators, there are numerous bodies that provide meaningful certification for medical translators and interpreters.

There are two options that are frequently overlooked, and others that are similar in nature. If someone can get certified as a translator with the United Nations, the World Health Organization or any similar organization, that certification will carry a great deal of value no matter where someone wants to work. That being said, it is probably not going to be very likely, even during the current global outbreak, to work as a translator or interpreter for clinical trials alone.

As tragic or as ironic as it may seem, however, incidents like the current global medical crisis will provide an increased opportunity to enter the field as a certified medical translation specialist or interpreter. This is especially true if the individual has personal experience in both the language and the culture of both languages being used for translation. Organizations like the EUATC in the European Union or the National Board of Certification for Medical Interpreters in the United States offer different options for medical interpreter and translator certification that is sufficient to meet most local medical care provider requirements.

It is also important to remember when learning how to become a certified medical translator or interpreter to research the school or organization with whom one hopes to study. There are always companies and organizations that will offer great deals, but what will matter most is the accreditation behind the certification process. If the translator or interpreter certification is not properly accredited by some regulatory body, it will most likely be completely useless.

Why Medical Professionals Should Use Only Proven and Certified Translation Agencies

As was previously noted, it is necessary for the up and coming professional translator or interpreter to do their research before committing to any course or agency that is not fully accredited. Likewise, medical professionals, conducting clinical trials or otherwise, have a responsibility to themselves, their peers and their patients to utilize only proven professionals in the field of medical interpretation and translation.

There have been cases where clinical studies were compromised due to poorly translated medical documentation. It should not be surprising that many of these have occurred during “rush jobs” often in the midst of harried times during the middle of an ongoing global pandemic just like the current Covid-19 crisis. There should quite literally be no room for error in terms of medical translation and interpretation, despite the continued use of untrained people to provide these services.

In many cases, it may seem far more convenient to allow a relative or a friend to translate for the doctor and the patient. This is far too frequently the case in emergency rooms and other high volume medical care facilities, where the patients may not always be among the most well-off financially. Still, even the slightest error in interpretations for treatments, the administration of medication or other seemingly minor details can potentially have devastating if not deadly results. Just as the patients deserve nothing less than trained medical professionals, they also deserve nothing less than trained and certified medical translators and interpreters, as do medical researchers and healthcare providers.