Is the word “eclinical” meaningless jargon? A good way for people to pay lip service to the future without actually building it?
The people at Medidata Solutions have been trying to lend some definitional and operational clarity to what “eclinical” means. Two months ago, they announced Developer Central, a set of standards to facilitate the connection of different clinical systems. (Here’s the release.)
In geek terms, the company’s Developer Central is an application programing interface (API). In Medidata’s case, it’s also a company-moderated online forum for problems and solutions to be shared between Medidata and its partners and customers.
Even for small sponsors of clinical trials, connecting disparate information systems is never pretty or for the faint of heart. To speed the work, Medidata is leveraging its support for the operational data model, a way to organize clinical data developed by the Clinical Data Interchange Standards Consortium (CDISC).
“This history of those one-off systems and the cost of maintaining them has driven demand for things like Rave in general and lead directly to us trying to do something like Medidata Developer Central,” says Medidata president Glen de Vries. “We want to build these things in a way that’s not going to be brittle, that’s going to be easy to adapt, and that’s why we’re so driven by using industry standards.”
“We really are taking that platform approach,” he adds. “We are one of the core enterprise pieces of an eclinical solution.”
Just as Salesforce.com and Microsoft Word allow other companies to connect companion solutions that work in the Salesforce or Windows environments, Medidata hopes to enable ways for clinical data to be piped from one program to another. In some respects, the company may be aspiring to shepherd the development of a clinical Linux—an operating system for clinical trials. Says de Vries: “The openness is what I think makes our eclinical vision slightly different than having a proprietary set of partners.”
Indeed, the New York City company says it does not plan to build or control everything itself, just to publish specifications on how clinical data should be moved and managed via the web. To prove that, it has already signed up most of the leading providers of patient diaries, which can inject their data into its system. It doesn’t need to stop there. The data could just as easily flow out to a submission-ready format for analysis or to some other system for reports. Voila! Eclinical, v.1.
The company is also talking about a term that is bandied about much less frequently, because of the high technical challenges it presents: interoperability. As best we can deduce, interoperability means enabling programs from different companies to share (and, ideally, not lose) data in real time.
Today, of course, most companies in the pharmaceutical industry have pockets of data stored hither and yon, in this department or that database, in this country or that computer program. Which in theory may have a few consequences for senior management that might periodically have to respond to hyperventilating Congressmen or nervous investors.
Is our site monitoring costing too much? Will this trial’s Latin American sites be as expensive as predicted? The ugly truth is that many companies in the pharmaceutical industry do not know the answers to such basic questions. They cannot draw upon any granular detail about a crucial company activity, clinical research, that would be customary and obligatory at companies like Boeing or Costco.
Or, as de Vries puts it: “People want increasingly high levels of transparency and visibility into their clinical trial operations. Without having interoperability in a platform like Rave, it’s really not possible to get to the penetration or get to the level of pervasiveness, in terms of eclinical operations, for a sponsor to really start to build the kind of insightful reports and get the metric views they need.”
De Vries does acknowledge a certain amount of confusion around the meaning of “eclinical,” but he doesn’t back away from the term or apologize for it. Rather, he seems to be hoping that his company and his customers can mix and match their preferred technological assets and assemble the eclinical future together. “The idea for us is, again, to drive people’s ability to innovate and not be the one who’s dictating what technology they should be using, provide a really open platform that people can build their future state eclinical information structure on,” he says.
But de Vries is not contending that the benefits of such a shift are 25 or 30 years away. They’re closer at hand. He argues that some sponsors will choose clinical trial applications for their ability to play well with others. “As people start to streamline those, and really create operational excellence in their clinical development programs, we really think that’s going to create some competitive advantage for customers, for our customers, potentially in the very short term. It’s a huge process efficiency you’re talking about.”
He provides a mundane but universal example. Imagine a three-way connection between a system for EDC, a clinical trial management system (CTMS) and a financial system that generates payments to sites. Medidata believes that it would be easier to connect those three systems once, and not fiddle with the same tricky wiring and quirky plumbing over and over again, one trial at a time, ad infinitum into the future. In theory, if it can be built, such a platform could significantly affect how quickly trials get going and how closely senior managers can track their progress. The vision is a grand and compelling one. Making it real will be challenging for Medidata and its partners alike.d9A2t49mkex