Global Trials June 2006 VIEW on Clinical Services Global Clinical Trials: Challenge or Opportunity? Ed Ikeguchi, M.D., Cofounder and Chief Medical Officer Sponsors are realizing that the ROI of EDC and global clinical trials comes not just from the implementation of those studies using technology, but from the prospect of achieving and streamlining truly global data management. Global trials open the door to unique opportunities. By expanding the population pool from one country to many, sponsors are able to overcome one of the most significant obstacles to coordinating efficient clinical trials: the bottlenecks and delays associated with patient recruitment. Opportunities for Global Clinical Trials Global trials allow sponsors to have access to more diverse populations, which is important for regulatory submissions. Sponsors can also more easily pursue multinational approvals, whether in the United States, Europe, or Asia. Most importantly, global trials bring critical exposure to clients — that is the doctors and nurses — who will ultimately become the prescribers of the medicine, biotechnology, or device. Overcoming Initial Technology Challenges Challenges can come from multiple directions, ranging from how tech-savvy the users are to Web-access issues to whether the technology itself has been constructed as “global-friendly.” Sponsors initially may have to work to overcome cultural perceptions of technology. Clinicians in most areas are technologically savvy, but in notable regions, cultural resistances to using technology still exist. These areas require more support and explanation of the value of the proposed solution and encouraging field staff to adopt new technology. The use of electronic systems in a global setting brings considerations, such as the availability of network access and training for sites that may be technology naïve. The importance of proper site screening and follow-on support becomes critical. Identifying factors, such as the availability of computers and network speed, are essential to a smooth project deployment. Software technology challenges include the need to provide an eCRF and software user interface (UI) in multiple languages. Furthermore, data entry in Japanese or Chinese, for example, requires software systems that can handle double (or even triple) byte characters. Beyond the basic data entry of double-byte characters, systems need to be validated for other processing of data, including reporting and outputs to statistical packages. Data that are entered in double bytes should also be viewed and handled by others involved in the clinical-trial operation. From monitors to data managers, the ability to handle queries, coding, data locking, and other functions should be able to be conducted using double-byte characters. Finally, for many global corporations, standardization of data into a single global database is a must. This usually entails translation of clinical data into English (or other languages) and coding with a standardized library. This is particularly true of studies conducted by global sponsors in Japan, and often leads to weeks, if not months, of delay in paper-based trials. Technology solutions should be able to facilitate the translation process as well as manage the workflow of data transformation into the global standards. Working on a Local Level As sponsors migrate to global electronic trials, they must recognize the need for localized services and support and for tools that streamline the way clinicians work at the site level. Sponsors should seek to implement an EDC architecture that is designed to provide complete clinical-data management as a single system. This single system localization and workflow management process can allow global sponsors to consolidate data from various site locations around the globe for reporting purposes and statistics generation, eliminating costly procedures. In addition, sponsors will require a highly scalable, fully Web-based architecture that is able to accommodate any brand of Web browser and any operating system, including Mac OS. Determining the Value and ROI Obstacles with paper trials are compounded and new ones arise when implementing clinical trials globally. Use of the right EDC system, however, enables everything from technology barriers to managing reams of paper to outsourcing translations to be simplified, if not eliminated. Sponsors deploying an EDC system for global clinical trials are able to realize the benefits of multinational trials, such as faster patient recruitment, while minimizing the challenges of global studies when compared with the paper implementation. Ultimately, sponsors are able to view data earlier, make site and study adjustments more easily, and increase site adoption by operating with standard forms and interfaces in the investigators’ native language. ROI comes from combining EDC and CDM into one unified system. Sponsors are realizing that the ROI of EDC and global clinical trials comes not just from the implementation of studies using technology, but from the prospect of achieving and streamlining truly global data management. Medidata Solutions Worldwide, with headquarters in New York, provides process design, technologies, and services to streamline clinical trials by providing earlier visibility to clinical data for faster decision making, optimized resources, and lower execution risks. For more information, visit mdsol.com.

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