Singular World
by Mary Sgammato
October 2007
Technology is playing an increasing role in helping trial sponsors and investigators manage trial data from multiple sites in multiple languages.
Large-scale clinical trials historically have crossed international borders and involved patients speaking multiple languages. Recently, however, the global reach of clinical research has expanded considerably. The challenge of finding prospective trial participants within highly competitive recruitment environments has contributed to the growing geographic scope of clinical trials, as sponsors and contract research organizations (CROs) seek new pools of prospective volunteers to ensure scientifically valid trials. Adding to the challenge of recruiting trial subjects is the often burdensome task of managing data collected in multiple languages. But by utilizing electronic data capture (EDC) and local translators, trial sponsors are learning how to best conduct global trials.
“International trials are nothing new,” says Christine Cramer, senior director of data management at PharmaNet Development Group, in High Wycombe, U.K. Cramer has managed trial data for nearly 20 years, and says that what is new is the growing number of trials being conducted in regions new to clinical research. “Over the past 10 years, trial sites have been expanding across eastern Europe and Asia,” she says, “and in the past five years, former Soviet Republic countries have increasingly contributed trial sites and study participants.” This global expansion of research is resulting in an increased need to develop a standardized system to manage trial data.
Late-Phase Challenges
Most multi-language challenges arise during Phase III and when using patient-reported diaries, which is when professional translators and local experts begin to develop language-specific data collection instruments. In these circumstances, technology can help investigators manage the disparate languages, characters, formats and dialects involved in a single large-scale trial.
EDC tools can help in regions that are new to clinical trials, Cramer says. “EDC allows investigators to be questioned regarding data anomalies on a real-time basis.” Since EDC tools are Web-enabled, information is accessible from anywhere. For trials with sites in certain areas, such as India, which has numerous regional dialects, and Africa, which has many local languages, the logistical translation challenges are especially daunting, Cramer says.
Depending on the phase of the trial, and the type of data collected, clinical reporting forms may be in a common language—most frequently English—or in the language or dialect of each trial site. “Phase II and III trials are generally conducted in English,” says Ivan Aranicki, Pharm D., European director of sales and marketing for Waltham, Mass., USA-based Phase Forward. But due to their smaller size and limited number of sites, Phase I trials may be conducted in the local language of the participating center.
Regulators in the United States and Europe dictate many of the standards for trials, Aranicki says, and generally require a common language to the greatest possible extent. Because submissions for new drug applications for both the U.S. Food and Drug Administration and the European Medicines Agency are written in English, and because the majority of trial investigators tend to be fluent in the language, English is the logical and practical common language across international trial sites, Aranicki says.
The Technology is Ready
“From a technology standpoint, data can be standardized across different languages,” Aranicki says. “If the need for multi-language case reporting forms increases, the technology is ready to handle it.” Right now, he says, regulators and trial sponsors seem to be balancing the need for electronic translation tools with the amount of effort required to deploy such systems, and seem willing to reserve the use of local language for late-phase trials. “There are many good reasons to run trials in English,” he says, “and most Phase II and III sites are relatively fluent in the language.”
Patient diaries and quality-of-life measurements do require the use of local languages, however. This is when medical translation experts become involved to ensure accuracy and consistency of data reported by the patients. It’s also important to set up data capture tools that are ordered identically across each language, and that quality-of-life measures are standardized. “You have to think about the data you’re collecting, make sure the tools are designed appropriately for each trial location and have native-language speakers check them for accuracy,” Cramer says.
“Many tools have automatic translation capabilities,” Aranicki says, “but in late-phase trials and when capturing subjective patient data, it’s important to have medical translation experts review and certify the translations.” In fact, language differences across trial sites no longer present huge obstacles for investigators. “We are very much in the middle of the world,” Cramer says, “and we are accustomed to working among various countries, regions and cultures. We just don’t see this as a hurdle any more.”
Send us Your Comments
Web Exclusives
- Statistical Advantage
-
Gary Shorter, director of biostatistics for Quintiles, talks to Envisage editor Adam Istas about the growing importance of incorporating biostatistical analysis into all stages of drug development.
- Measure for Measure
-
A proposed Health Care Comparative Effectiveness Research Institute in the United States may force the biopharmaceutical industry to emphasize patient outcomes and quality of life issues when developing a new medicinal product.