With evolving language capabilities, EDC is now open to nearly everyone.
By Ann Neuer
Oct. 8, 2008 | The use of electronic data capture (EDC) in the Asia-Pacific region is poised to equal or surpass more developed regions of the world, says Graham Bunn, vice president of global CRO partnerships at Medidata Solutions. “The exciting thing about the Asia-Pacific area is that it has traditionally been a lot further behind in EDC adoption but it seems to be catching up with Europe quite rapidly because sponsors are starting to understand and appreciate its advantages,” he says.
Specifically, Bunn is referring to the fact that EDC has evolved to the point that users around the globe can enter data in their own languages, and those data are combined into a single database, adding to project efficiency. This is exceedingly difficult with paper trials because paper case report forms in multiple languages have to be translated and typically cannot be handled in one database. Being able to enter data in various Asian languages brings an important level of accuracy to the trial and comfort to new users who are experiencing EDC for the first time. “In the Asia-Pac region, clinical trials generally cannot be run in English, so it is important to enable data collection in the native language,” Bunn says.
Another key advantage is the immediacy of EDC. With multiple time zones across Asia, sponsors and contract research organizations (CROs) can instantly see the progress of clinical trials, identify sites that are struggling with subject recruitment, and more easily include Asia-based staff and investigators in study-related communications and conference calls. Sponsors and CROs also appreciate the potential of EDC to reduce the number of costly monitoring visits—not a small thing in this vast multi-cultural region.
The move to EDC brings challenges, and according to Bunn, perhaps none bigger than the variable infrastructure across the Pacific Rim. “Infrastructure is definitely a challenge. In Singapore, 98 percent of everywhere has PC and fast Internet connections, and in Japan, the Ministry of Health, Labour and Welfare has launched a five-year national plan to expand use of technology in clinical trials based on CDISC standards. But in other parts of Asia-Pac, it is comparable to Latin America and how it was in Eastern Europe two or three years ago. Getting good Internet access and having efficient PCs can be a problem,” he explains.
Training can also pose difficulties. Many Asian sites are not familiar with EDC, so sponsors and CROs are turning to state-of-the-art EDC systems with built-in multi-language eLearning capability that does not require high bandwidth. Potential users can be restricted from accessing the system until they pass online tests about the technology. A number of marketed EDC systems offer this function.
And finally, there is the issue of culture. “This is one of the big ones,” says Bunn. Countries have different approaches, different languages and etiquette in running clinical trials, and this impacts how various Asian countries may view and accept clinical trial technology. The situation in Japan is changing quite dramatically as the International Conference on Harmonisation (ICH) lays the foundation for studies in the U.S., the E.U., and Japan to operate under harmonized guidelines and standards. Other countries in the region, however, are not yet aligned with Good Clinical Practice (GCP) guidelines. Bunn says, “Investigators have less clinical trial experience in some of these countries. In fact, some investigators are clinical-trial naïve, so they need training in running a clinical trial, handling the product, and EDC. They also need standard operating procedures. Locally based CROs can be enormously helpful in this effort.”
This article appeared in Bio-IT World Magazine.
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