Clinical Research Services in All Languages
Today, as the pharmaceutical market becomes increasingly global, major pharmaceutical companies are running clinical trials around the world, and professional clinical trial translation services become vitally important. For example, in 2006 GSK sponsored a multinational clinical trial to test a vaccine for avian bird flu. In Spain, the time for the test was substantially shortened as some steps were skipped. This was due to a decision by the Spanish drug regulatory agency which allowed for the shortened process because they felt finding an effective vaccine was a matter of top priority.
What was skipped? In this instance the clinics skipped translating the trial protocol into Spanish, instead only translations of the protocol summary and informed consent forms were translated. Although skipping these translations may have been in violation of the EU law, it did comply with Spain’s law, which does not explicitly require translation of the trial protocol into Spanish. However, the Spanish clinical trial ethics committees do require the translation of the protocol. Of course the concern with this is that researchers whose first language is not English would not be able to read and understand the technical information, jeopardizing the validity of the trials and tests.
The Medical Translation Issue
Typically this decision to forego translations is in response to past experiences that proved unsatisfactory, causing clinical trial sponsors and clinical research organizations to conclude that translations aren’t worth the costs. One common issue is that, in translation, the original meaning of the protocol has been changed. When the issue is realized, typically in the midst of the trial, the protocol has already been approved by the ethics committee and/or national competent authority and thus cannot be changed. Another issue with translating protocols is that it is believed to substantially delay the start of the approval process, in some cases by as much as 15 days.
However, the root of these issues is clinical trials using the wrong translation service. There are plenty of foreign language translation providers that specialize in the translation of clinical trial documents. Using the translators familiar with the clinical trial process and terminology will help avoid these so-called ‘translation issues’.
Yet the real issue with not having clinical trial protocols translated often has more to do with business than the translation process itself. For example, in the above cited GSK example, the company was pushing for the accelerated process as the fear an avian flu pandemic was spreading – making the development of the vaccine a high priority for public health. More so, another company was also in the midst of developing a similar vaccine and being the ‘first out of the gate’ was crucial to the profitability of GSK’ vaccine.
So What’s the Legal Issue?
Granted, national laws typically do not explicitly require the protocol to be translated, so where is the legal issue? The legal issue is compliance, and, down the road, potential product liability lawsuits. For example, if the documentation is provided in English only, this may significantly limit the number of researchers, administrators, staff and ethics advisors able to read and understand the protocol. This will lead to errors in data collection and recording. When errors happen, trial participants can be harmed and lawsuits will be filed. Does the program’s insurance policy cover the cost of compensation to patients for damages caused by inadequate translations? The answer to questions like these likely lie at the end of a long and costly legal action…