Although the COVID-19 pandemic has brought upheaval and uncertainty to our profession, it has also been an opportunity to catch up on continuing education. However, I will not be reviewing any recent webinars on weathering the crisis or pivoting to remote interpreting. Today, I’d like to turn to an unexpectedly topical video from the ProZ.com video library—a repository that features webinars previously broadcast on the website. Disclaimer: Other than being a paying member, I have no business relationship with ProZ.com.
The video I watched was Clinical Trials and Medical Documentation: Resources and Translation Strategies for New Translators presented by German- and Arabic-to-English medical translator Carmen Cross. The live session took place back in 2016, but I found the presentation relevant to anyone getting started in the field of clinical trials.
Trial Background, Standards, and Terminology
In the first section of the webinar, the instructor gave an overview of the types of documentation produced in a clinical trial. Documents that may need translation include informed consent forms, patient information sheets, and serious adverse event reports. In addition, the speaker shared what areas clinical trials focus on. Even though our first thought may be drugs, Ms. Cross pointed out that other things may also be studied, such as medical devices or diagnostic procedures. She then went over some commonly studies drugs and drug targets (molecular entities the drug binds to). Next, the webinar focused on some common types of studies, including diagnostic, epidemiological, pharmacokinetic, and pharmacodynamic, among others. Finally, we looked at the phases of a trial, examining the objectives, number of participants, and length of each phase.
The following part concerned international standards that govern clinical trials, such as the International Conference on Harmonisation’s Good Clinical Practice (ICH GCP) addendum or the World Medical Association’s (WMA) Declaration of Helsinki. Ms. Cross named a few regulatory authorities overseeing clinical trials, such as the Food and Drug Administration (FDA) in the US, the Medicines and Healthcare Products Regulatory Agency in the UK, or the Public Health Institute in Russia, and emphasized that study sponsors apply to these bodies for approval. The documents involved in the application process, for example an investigational new drug application (IND), may require translation. The presenter pointed out that the actual research gets outsourced to the contract research organizations (CROs), who are responsible for trial data, and they may be the entity that needs translation services.
Finally, the speaker drew our attention to some tricky terms in this field and shared several resources we might want to turn to in our research. To name a few, she discussed the difference between efficacy and effectiveness; clinical trial and clinical study; and subject and patient. Ms. Cross recommended PubMed, which allows you to search in a particular language, and ClinicalTrials.gov, which lets you search for the full official title of the study by its ID.
I appreciated that the speaker not only provided an overview of clinical trials but also pointed out what organizations may be looking for translations, what documents may require translation, and where to look for terminology. She also listed the top countries where clinical trials are conducted—Russia, Turkey, China, Brazil, India, South Korea, and Mexico. Her advice was actionable and tailored to translators.
An obvious drawback of this webinar is that it was recorded in 2016, so some of the standards and processes might have changed since. In fact, the speaker mentioned that a new clinical trial regulation (EU No 536/2014) had been adopted, supplanting an earlier European Union directive, but its implementation was going to be gradual. I would still recommend this webinar to anyone interested in clinical trials, with the caveat that the viewer will need to do their own research to find up-to-date information.
Maria Guzenko is an ATA-certified English<>Russian translator and a certified medical interpreter (CMI-Russian). She holds an MA in translation from Kent State University and specializes in healthcare translation. Maria is a co-founder of the SLD exam practice group and the host of the SLD podcast, now rebranded as Slovo. More information can be found on her website at https://intorussian.net.