How to write about information technology in the global scene of clinical research? Well, the Internet took care of that, didn’t it? Someone in Ecuador can bid on an item on eBay, posted by someone from Slovakia, so what can be more global than that? End of topic. Hmm, perhaps not.

It appears that biopharma’s global use of information technology in clinical research is no more advanced than its global approach to clinical research in general, and while that might seem logical, biopharma’s “globalness” is much less advanced than the technology it could be using (or even might be using) to support it.

In part, biopharma’s use of technology varies in parallel to the individual company’s approach to being global. At one extreme is the company which has multiple, heavily-staffed, clinical development centers around the world. Such a company must rely heavily on computer technology (modern or not) to even function. Companies which are more in the middle of the spectrum – what could be called “hub-and-spoke”, where there is a primary company site and other country locations are quite small – also need technology in order to effectively tie together the many threads of the clinical research organization. Even if a company is essentially “mono-national”, most any company still finds itself running trials in multiple countries, and thus face certain technology challenges. The same can be said for CRO’s, since they range from the tiniest, serving only their local patron sponsor, to the huge multinationals who teeter on the edge of fragmentation in process consistency.

Running global trials, or running a global organization, raises common challenges to effective use of technology, as well as providing needs and opportunities for great benefits.

The least technical factor can have quite an impact – basic cultural variations. For instance, we are familiar with how investigator sites differ importantly among the US, Europe, Japan, India and all the many new countries where trials are being conducted. Sites vary in staffing (are there are study coordinators available to enter EDC or CTMS data?), technical equipment (are Internet — versus intranet – connections available? Is there a local printer? Does the site need a computer provided?), and connections (is wireless more ubiquitous in a country than wired connections, is Internet access really universal?). For instance, so-called “provisioning rates” (how often hardware or a high-speed connection must be provided to a site) varies widely even across a single border in the same region of the world, or indeed, within a country. And sites can differ widely on their expectation of whether a sponsor-provided computer or ePRO PDA is supposed to be returned to the sponsor or retained by the site after the study close. These become very sensitive situations which are not necessarily best addressed by single worldwide practices.

But subtler cultural variations will impact clinical technology success. Countries and cultures who historically feel they are treated unequally will be particularly sensitive to situations like date fields in a form which only accept one date format (the order of year, month and day), or form instructions which use English vernacular which is too idiomatic or culture-specific (even a Canadian or Australian can react negatively to an “Americanism” in wording). This kind of reaction can undermine the benefits and performance of the tool being used: if a CTMS relies on a Web-based Portal which is designed based on “first-world”, high-web-use user conventions and language, and is expected to be used in developing countries or places with low-web-consumer practices, the Portal may simply be under- or un-utilized and thus deny critical information to the study team. In such a situation, the ability to localize the Portal design, or the eCRF in and EDC study, would be an important consideration.

Data entry practices will vary globally, not only at sites but among sponsor/CRO field monitors. It is less true, but still true, that in some countries Principal Investigators may be the only ones entering data into an EDC eCRF. This in turn will dictate a very different pattern of frequency and quality which has to set a different set of expectations for the sponsor’s workflow, even within the same study. Another example is the variation of electronic health record (EHR) use around the world. Some countries are more advanced than others, and more standardized, or intend to be. This may be one of the most important challenges to eClinical trials in coming years.

Perhaps nothing is more important on a day-to-day basis in eClinical use globally than how end users are supported on basic technical and clinical questions and problems. How the sponsor designs and supports its users through a Help Desk service is critical to the success of EDC, ePRO and CTMS, or even geographically distributed adverse event tracking systems. We all have our favorite hate-the-Help-Desk anecdotes; the challenge for sponsors pursuing eClinical processes is to make sure they don’t generate new anecdotes!

Even application integration is more of a challenge when conducting trials globally. First, of course, is the challenge of speed and data integration of combining multiple instances or data stores of the same application. More difficult is integrating data sources from multiple countries and the CROs and other third-party sources (like core labs) usually used in global trials. More difficult still is considering the integration of disparate UI (user interface) approaches: it is easier to adjust a CTMS UI to local cultural conventions than eCRFs which are necessarily more driven by a concern for standards. As EDC and CTMS applications increasingly need to be integrated, these interfaces (and resulting data formats) may clash.

Last but not least, running global trials means juggling diverse regulatory requirements around the world. The challenges are myriad, such as ensuring your AES is generating all the different required reporting forms on the different reporting schedules, managing the differences in data collection conventions (such as race definitions), ensuring compatibility with eSubmissions requirements, fulfilling local patient privacy protection requirements, and more.

All of these situations perhaps could be addressed through a robust set of requirements developed by a multicultural working team. Certainly so, but of course this solution would be at least as challenging as the procedural questions raised above. As poorly designed as most requirements development efforts are, they particularly disappoint when trying to effectively and respectfully balance cultural differences, priority issues, and tight timelines.

Despite what Walt Disney may have led you to believe, when running global clinical trials with modern eClinical technologies, it is indeed still a large, diverse and hyper-sensitive world, after all. To realize the prodigious benefits of subject availability, disease distribution, market experience, and flexible labor pools, biopharmas will need to learn how to exploit information technology despite the global challenges.