There are more myths than truths about using IT in global trials.

Conducting clinical trials globally is an essential component of any biopharma’s clinical development plan. Large or small, regardless of therapeutic specialization or Phase, clinical trials are increasingly conceived and implemented with subjects literally from around the world. One can confidently argue that such a strategy would be impossible without today’s information technology – from the basics of email to the most sophisticated clinical supply resourcing algorithms. Certainly electronic data capture is at the heart of most global trials, and some means of keeping tabs on global trial management through technology is also essential, be it simple spreadsheets or elaborate tracking systems.

Nonetheless, there is another truism about the use of information technology in global trials: there are more myths than truths about using IT in global trials. This column will touch on just a few examples.

Let’s start with one of the most common: computer technology can’t be used in the developing world where all our trials are. This is one of the enduring and inexplicable myths. It is the worst sort of first-world arrogance that we assume developing countries don’t know what the Internet is. In fact, many developing countries have benefited, if that is the word, from getting such a late start in telecommunications. When the world’s high-tech Help Desks are located in Hyderabad and Sofia, and the high-speed wireless infrastructure is better in Eastern than Western Europe (and much better than most North American city neighborhoods), you realize how mythological this statement is. Talk to monitors who work in the developing world and they will tell you how they wish their home office had such a good connection. EDC vendors have claimed their tools have been used successfully in over 100 countries. The hardware is increasingly ubiquitous at lower and lower costs. Certainly, many sponsors find that it may still be necessary to “drop in” high speed connections to their desired investigative sites, but this too is decreasingly necessary. When you realize some of the largest sellers on eBay are in countries like Malaysia, and eBay’s buyers come from literally all over the world, how do we in pharma justify such snobbery or ignorance?

Let’s start balancing the myths right away: the clinical IT vendors have laid the groundwork for your global use of their software. Alas, not quite so. While several vendors have very broad exposure to countries all over the world, this by no means translates automatically into local execution excellence. They are as likely to be discovering the right and wrong ways to get connected (or in the case of ePRO, move hardware in and out) in real time on your trial’s nickel, as they are able to come to you with the answers in hand from the beginning. The failings are particularly acute when considering the areas where the vendors consistently underperform regardless of country – providing consistent, knowledgeable project managers, and providing a help desk service that does its work correctly, every time.

Well, then, let’s assume a global CRO is prepared for technology use in global trials. Unfortunately, this ain’t necessarily so at all. More often than not, a global CRO is in fact a poly-organization, not an integrated one. So their local office (like your local affiliate) should indeed be locally knowledgeable, but there are few mechanisms for this local knowledge to contribute to a single global management sophistication. Much like the false promise of “e-ready monitors”, “global CROs” are global only “on average,” in a very general sense, and it is in the particulars where global trial management matters. Technology is usually the last particular to be learned. Two examples: a famous mega-CRO assured a big pharma that it could handle a complex EDC-enabled global oncology trial, only to supply monitors and local project managers who were EDC naive. In another example, a “global” technology support service had to quote extremely high support prices for a trial because they needed to cover the risks of support in areas where they had never really worked – areas where most pharmas want to be doing trials.

Ok then, find a local CRO, and they’ll take of it. This may well be worse. Most local CROs simply are too small and inexperienced to offer much help in technology application to your trial. Their naivete translates into higher training costs and lower quality. Worse yet are those who offer you their own EDC or ePRO or CTMS tool, which in almost every instance will be missing key quality, performance and compliance characteristics. This is again caused by the fact that the tools were built for local studies, usually post-approval, and usually for a fatally unsophisticated small sponsor.

Non-US investigators won’t use pharma-supplied computer tools. Like the first myth, this could not be further from the truth. Those large pharmas with the most experience in global trials will tell you how the investigators in the least developed countries are the first to push back on sponsors to use EDC, trial and supply tracking, IVRS, and other tools. European investigators, both Western and Eastern, have historically been the pioneers in EDC and ePRO since the early 1990s. Latin American investigators were embracing early ePRO 15 years ago. And now as Japanese-based pharmas seek worldwide registrations, even the assumption that Japanese investigators require Kanji interfaces is no longer true.

Nonetheless, beware the global-is-easy myths also: software is a universal language, so training can be universal. This is not true as applied to the content, language or method. Different cultures demand different training approaches. If you seek to meet the EDC user certification requirement robustly, for instance, you may need to translate your training. In some countries, local regulations are forcing parts of training (like data privacy) to be locally specific. And if “universal training” means “via the web”, unfortunately you are likely to know even less about the true uptake of your training, because the use of English as a second language (or cultural barriers) will inhibit questions by attendees and prevent you from evaluating true understanding.

And then there is perhaps the ultimate myth about technology in global clinical development: using technology will enable me to off-shore my development to solve my problems. Big IT companies and big CROs with lots of dollars at stake are counting on the off-shoring of most clinical operations functions to amortize their off-shore investments, off of your dollars (or euros). But if you can’t execute locally – either in your home offices or in your affiliates under your direct management, what makes you think you can execute 12 timezones away with non-native-English speakers? Talk to the companies who outsourced first, ahead of the curve: they are bringing the business back, because no amount of “follow the sun” technology could replace the burden of long-distance project management.

So what is true among these myths? Global trials are essential, and they are hard work. Information technology is never a quick fix, it is only an enabler, and even then, it is only excellence in management and execution that makes the technology help your global trial work. Go global, not loco. There is no free lunch, no matter what cuisine it is served in. Get past the myths and discover the truths of effective global development, one trial at a time.