There is much for sponsors to consider when purchasing an EDC system beyond its ability to collect patient demographic and clinical data, says John Murray, co-founder of Procela Partners, a Dublin-based global management consulting firm. Associated attributes, or “metadata,” provide more potentially useful information – for example, when and by whom data was collected, if it came in clean, and how many patients were recruited by specific investigators.
All this “sideband” information holds promise for better managing clinical trials in terms of site selection, clinical trial supplies, and investigator relationship management, says Murray. Choosing sites based on investigator-specific recruitment and data-quality information “is worth far more than a blast out to 100-200 investigators for a trial and the hope that, on average, they’ll pull in enough patients.” Sideband data may also help ease some of the “hassles” of being an investigator -- including timely payment and drug delivery -- which is one reason why 50 percent of physicians only ever do one trial.
The area of investigator relationship management, in particular, is “ripe for exploitation,” says Murray. Which investigators need to be recruited for a particular study and which institutional review board the protocol will go through is the kind of information that “ought to be captured the first time [a company] does a trial and used as baseline…again and again and again,” says Murray. Capturing knowledge, rather than reinventing processes, could lead to a host of associated improvements in the speed and cost of establishing trials.
EDC vendors may, or may not, provide metadata in a format that can actually be used by other systems or the master architecture of a central repository, says Murray. Often, that has meant conformance with XML or Oracle standards. One way or another, that integration “needs to occur.”
The Future Landscape
The kind of integration needed for true “dashboard functions” will require more than CDISC (Clinical Data Interchange Standards Consortium), says Murray. Some vendors are writing conforming software code as an interface, but implementation still varies from company to company. “There will always be differences and choices about how a particular standard will be delivered by a particular vendor.”
EDC systems could well be the mechanism enabling the “adaptive trial” process by which dosing regimens get quickly modified based on patient response, thereby finalizing trials sooner, says Murray. Linkage to trial supply systems would further eliminate product waste.
Leading EDC companies have “crossed the chasm” from self-promotion to success and now must make the difficult transition to meeting the “established needs of the mainstream market,” says Murray. To properly service all the new business, vendors “can’t say yes to every customer request.” Doing so will end up costing them customers and, potentially, their business.
Moving forward, contract research organizations (CROs) will need to modify their service and basis for making money or end up, at best, as niche players, says Murray. CROs that don’t get on board with EDC risk “disintermediation.” All the major study sponsors have converted to EDC and will be offloading work only to CROs that have done likewise. etrials Worldwide built a “clever” technology transfer model whereby CROs can generate revenues as software service providers. To make the switch to EDC financially palatable, CROs must be willing to abandon costly and duplicative paper-based processes.
It’s a mistake to think that any of the big service application providers on the manufacturing, accounting, or human resources side of the house will develop software in this specialist space, “other than by acquisition,” says Murray. In clinical development, both data and regulations are in constant flux. Oracle will remain the exception by virtue of good timing and its underlying clinical trial management system.
In terms of financials, there will always be “an element of nervousness” among industry sponsors when dealing with EDC vendors, says Murray. Even the revenues of Phase Forward and Medidata are “dwarfed by the expenditures of pharmaceutical companies on clinical trials.”
Related article: Speeding Up EDC Adoption
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