Given that industry urgently needs both EDC and clinical sites, the distress is likely to continue. None of the design constraints—on sponsors or on regulators—will mutate. Ever. EDC did not emerge in a vacuum. While serious, the concerns of sites are not of such magnitude to force slow-acting sponsors to switch EDC systems or redesign them.
So the industry’s usage of a key research system is likely to be one of several grating, annoying factors that are accelerating the disengagement of U.S. biomedical scientists from industry research. Which is sad. Some industries facing such an issue would scramble to take action.
In pharma, oddly enough, other eclinical systems are even harder to use than EDC. Some of these systems are used by sites; some are not.
The problem is profound. Companies like Amazon and Yahoo have raised the bar of usability to a point where industry systems for clinical trials now seem antiquated and unnecessarily complex. Eclinical systems tend to have too many cryptic boxes, icons. How do I get to what I need? What am I supposed to do on this screen? Amazon and Yahoo have built easily navigated websites despite dizzying amounts of content and things to do. Can your vendors say that? Your contract research organization (CRO)?
The situation is complicated by a rapidly growing world of mobile applications. As the antique Palm and Blackberry platforms stumble like dinosaurs, there are two sleek new species of applications for Apple’s iPhone and Google’s Android devices.
Ordinary people, ordinary users will come to expect no-training-needed, dead simple software. Just as teenagers disdain email and use text messages instead, adults will disdain spending time on software with incomprehensible Windows dialogue boxes. Ordinary mortals will use their mobile phones for as much work as they can.
The world is shifting in favor of super-easy software. No one in their right mind uses Windows-based tools to edit high-definition video. For photos, the free Picnik runs inside a browser and is easier and faster than expensive, desktop-based brontosaurusware from Adobe.
The contrast with eclinical systems is just as stark. The distance between systems for industry research and the rest of a digital lifestyle in 2010 is incongruous. Gaping. Most typical clinical trial management systems (CTMS) or randomization engines will seem as out of place as riding an Amish horse and buggy into a modern airport. Whoa, boy! Have a little hay, you might say upon reining in your steed at O’Hare International. This nice policeman needs to scan our saddle bags.
That’s the unlikely position the sponsor community is finding itself in 2010, two decades after first exploring EDC and testing it. Some anti-technology CROs are more disadvantaged: they have only dreamed about owning a horse.
The consequences? Efficiencies that sponsors anticipated will never be realized. Sponsors with especially awful software for clinical trials will lose some sites to competitors that ask their sites to use slightly less terrible software. That’s what will happen if the status quo is tolerated.
The solution? It’s easy. Some sponsors would lack the Steve-Jobsian boldness to try it. But it would work.
Proactive sponsors could start convening user panels with representatives from multiple clinical sites. The usability of key clinical trial systems would be reviewed in depth. Systems that are just too hard to use should be placed on the corporate equivalent of a no-buy list. In short, banned. A memo to the purchasing department would take care of everything.
The systems on the no-fly list should be deemed ineligible for consideration. Offending companies should be invited to reapply for eligibility every eighteen months.
Many clinical sites feel that the sponsor community is not serious or sincere about improving their tools. Sites assume that the sponsor community is just providing rhetoric. Rhetoric alone leads to cynicism. Amazon and Yahoo don't need rhetoric; their websites are relentlessly improved in countless tiny ways.
An eclinical no-fly list would be a small, credible, verifiable indication that a sponsor actually cares and is taking one small, concrete step on behalf of sites. It would be much better to make a statement such as: We formerly used the [name] system, but we heard a few complaints, and it’s banned for this year’s trials. We’re trying the system from [name] instead, and are finding it’s a bit better.
As a few vendors get blacklisted, word will spread. In the vendor community, additional resources will be put into ease of use, performance, general navigability, and other factors that make Amazon and Yahoo so enjoyable. Fixing eclinical systems will take years. It will be hard. But a no-fly list will be preferrable to having vital research partners like sites turn up their noses and say, No, sorry. Your technology is too frustrating. Sites are already thinking that. It’s overdue for sponsors to make the same cold self-assessment.