Global trial translation—blessing or curse?*
Sponsors and contract research organizations (CROs) now launch trials in markets around the world. Regulators want larger population pools, longer-term monitoring, and more trials. Pharmaceutical companies are developing relationships with clinicians and physicians in locales around the world to build advocacy for new products in new markets.
Translation is the cutting edge of the communication scalpel for this new global community of clinical trial stakeholders. This issue of language is as critical to the process as patient screening or any other trial-planning element.
The fail in “fail to plan”
For such serious business, it is a good idea to consider translation at the start to avoid trials at the end. Planning for translation is most successful when it come early, so that everyone involved understands the costs, time-lines, and requirements essential to good risk management of a translation effort.
Translation as an afterthought often results in stretched timelines and renegotiated budgets. Poor planning can delay execution and makes outsourcing organizations look bad.
While clinical trial cost may be lower in some markets, budgets need to include the cost of communicating with all of the participants in a trial. Most of the materials involved in the clinical trial, such as the investigator’s brochure, the clinical study protocol, subject information and informed consent form, clinical study reports, patient reported outcomes (PRO), and the case report form will need to be translated into language easily grasped by participants. During the trial, patient diaries, adverse event and other in-country trial materials will need to be translated back into the control language (usually English) to ensure accurate data collection and analysis.
Clinical trial translation is uniquely challenging for translators. Terminology is often specific to the individual trial, and content always reflects the cutting edge of life science research, expressed by writers deeply involved in the industry. This complexity has to be expressed simply enough so that patient participants with limited health literacy can understand. Finding linguists who understand the language of investigators and can communicate the same to end-user is the most challenging part of the translation process. Linguists have to know their medicine and their audience.
Translation goes global
In a global effort, economic models and risk profiles cannot ignore the complexities introduced by language and culture. If inputs do not consider the cost, complexity, and risk associated with translation, trial goals could be jeopardized.
As trial elements are designed, consideration has to be given to localization. This could be something as simple as making sure that there is enough room on the form to fit a text that has expanded in the translated language, or as complex as mapping out the cognitive category of each word used.
As a first step, a decision has to be made on what to translate. Most important are the materials that will be read by patient populations and physician sponsors. If these documents are translated on demand, even linguistically correct translations may miss nuance or author intentions that will make the content harder to understand or decrease accuracy.
While it is possible to recruit English-bilingual study participants in many markets, this can skew the patient pool, complicate recruitment efforts. Since English ability is often over-reported, English-only studies using bilingual participants can sometimes lead to greater risks from misunderstanding.
The cost of translation is a small share of overall study cost, but the cost of delays in translation can be staggeringly high. Translation bottlenecks can get very expensive if time to market is delayed.
Next time: Best practice
*Blessing. All the translation tribulations of global trials are a blessing. Saving lives is a blessing.