Quick Q&A

NGP. What are the opportunities for sponsors initiating global clinical trials?
EI. Global trials open the door to unique opportunities. By expanding the population pool from one country to many, sponsors are able to overcome the bottlenecks and delays associated with patient recruitment. Global trials allow sponsors to have access to more diverse populations, which is important for regulatory submissions. Sponsors can also more easily pursue multinational approval, whether in the US, Europe and Asia. Most importantly, global trials bring critical exposure to clients, the doctors and nurses who will ultimately become the prescribers of the medicine, biotechnology or device.

NGP. What are some of the initial challenges to deploying global electronic clinical trials?
EI. Challenges can come from multiple directions, ranging from the tech-savvy of the users to web access issues to the construction of ‘global-friendly’ technology. Sponsors may initially 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 an explanation of the value of the proposed solution and in 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. The ability to identify factors such as the availability of computers and network speed are critical 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 is 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.

NGP. What is Medidata’s approach to overcoming these challenges?
EI. In assisting sponsors in their migration to global electronic trials, Medidata has recognized the need for localized services and support and for tools that streamline the way clinicians work at the site level. Medidata’s Rave architecture is designed to provide sponsors with a complete clinical data management as a single system. This single system localization and workflow management allows global sponsors to consolidate data from various site locations around the globe for reporting purposes and statistics generation, eliminating costly procedures. Rave is highly scalable, being fully web-based and able to accommodate any brand of web browser and any operating system, including Mac OS.

NGP. What are some features that Medidata’s Rave platform offers to help manage global trials?
EI. Using Medidata Rave, sponsors are able to create studies in a single library with reusable forms, visits and studies that can be subsequently localized for different languages. This way, sponsors can avoid the burden of recreating separate clinical research forms (CRFs) in multiple languages. Medidata Rave includes support for double byte characters in the user interface, data entry screens and clinical data itself. Web-based tools allow for the translation of data entry screens into multiple languages, and pick-list data can be presented to users in their local language and automatically translated for reporting and analysis. For example, upon log-in, a clinical investigator in Japan will see the same form in Japanese as someone in Europe does in French. Free-text data entered in different languages, including coding data, can be queued for translators who can complete their work online, enabling truly global enterprise deployments.

From the standpoint of multilingual capability, the Rave system is fully double-byte character enabled in all aspects, from data entry to monitoring to data management functionality. In addition, a unique aspect of the Rave system is that there is an intrinsic localization capability, enabling a user’s preference dictate the language in which the software UI is presented. This is in contrast to situations where there is a separate ‘English’ version and a ‘J’ version for Japanese or other languages, leading to disparate databases that sponsors still need to transform into a global standard. To further enhance its localization capability, the Rave system manages the workflow required for multilingual studies to occur, with specific roles for translators and coding specialists.

NGP. Where are sponsors seeing the value and ROI of EDC in global clinical trials?
EI. Obstacles with paper trials are compounded and new ones arise when implementing clinical trials globally. However, using Rave, everything from technology barriers to managing reams of paper to outsourcing translations can be facilitated, if not eliminated. Sponsors deploying Rave 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 to the paper implementation. Ultimately, sponsors are able to use Rave 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.

Significant ROI comes from the combination of EDC and CDM into one unified system. Very quickly, sponsors are beginning to realize 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.