Nextrials is a small but visionary San Francisco-based electronic data capture (EDC) firm. It had some ideas that took competitors years to duplicate. Nextrials offered built-in patient randomization, drug supply and adverse-event reporting years ago. We last wrote about the firm here.

When we recently checked in with Nextrials' president, founder and CEO Jim Rogers, he said the economic downturn had affected the pace of business. “The economy has had an effect on our biotech customers,” he says. “There are going to be a lot of biotech companies that are not going to make it. The number of the studies and scale of the studies is reduced across the board.”

Fortunately, registries are in demand. Nextrials has been simplifying its user interface for those projects, and adjusting its fees so that a five-year project does not become prohibitively expensive.

Trial Exports

Nextrials and Formedix have adapted a Formedix study design tool called Origin. The software can speed study start-ups by weeks, allowing sponsors or contract research organizations (CRO) to configure a database and design case report forms (CRF) for a trial once, and export that information in a manner that can be loaded into three EDC systems—those of Nextrials, Oracle and Medidata.

The growing size of those two companies does not worry Rogers. He says the top two EDC firms are seldom interested in supporting trials with EDC budgets less than $500,000 or $1 million. Whatever their preferred minimum project size, Rogers says, the figure is only going to be higher in the aftermath of Oracle’s purchase of Phase Forward. For a multitude of companies with smaller budgets, his system will be more affordable.

As we've noted in the past, Nextrials is participating in another trend in the EDC landscape: the effort to sync up with electronic health record (EHR) systems. As many readers know, American doctors are rushing to buy the systems not just because of large federal subsidies, but also because of potential financial penalties for not using them.

Nextrials is one of a very small number of EDC suppliers (Outcome is another) actively working on what can be done now, exploring both trade show connections to EHR systems and real trials. The acid test for such companies is the Connectathon, a purely technical gathering that tests the interoperability of EHR and EDC systems. Only survivors of the Connectathon are allowed to participate in a glitzier conference exercise, the HIMMS interoperability showcase. Nextrials, needless to say, has been a regular at both events for the past three years.

Site Pain

For starters, Rogers would like the pharmaceutical industry to put more energy into making sure its systems will connect with those in physician offices and hospitals.

Alas, big technical issues remain unsettled by U.S. regulators. That allows doubters to say the EDC-EHR linkages will never matter. The FDA has yet to define electronic source documents clearly, or to codify the legal methods for cleaning clinical trial data that are drifting in and out of 21 CFR Part 11-validated systems. Given the pace of making new policy in a dysfunctional U.S. political system, that might take a while.

At least the European authorities are starting to put a few things down in writing. The European Medicines Agency (EMA), Rogers notes, has issued a final version of a nonbinding document about electronic trial data and EHRs. The thinking that went into the document impresses Rogers. Only half joking, he proposes that FDA officials photocopy it and apply an FDA logo to it.

Dear FDA ...

“The document from EMA was very well written, very thoughtful, very clear, not the usual FDA stuff—and actionable,” Rogers says. Among other things, the Europeans developed a 12-point checklist to determine if something is a source document. “It would be nice if the FDA would clearly state it in an FDA guidance the way the EMA did,” Rogers notes. “It doesn’t need to be a regulation. It just needs to be a guidance. That’s all we’re looking for.”

In Rogers’ case, some of the impetus behind the EHR-EDC integration effort is a sincere desire to address the concerns that clinical sites have about EDC. Referring to an article published on ClinPage earlier this year, Rogers acknowledges that sites do not always love EDC from any supplier. Says Rogers: “There is frustration, even anger, when we talk to sites. The perception is that EDC is more work.”

He views the EHR-EDC shift as something that would alleviate the situation. Rogers allows that while any EDC vendor’s solution may be easy enough to use on its own, the collective burden of navigating multiple EDC systems is a problem for the industry as a whole. Perhaps a fifth of clinical sites, after all, have five or more EDC systems at the same location. “All of the easy-to-use systems piled on top of each other become a tower of Babel,” he says.

So Rogers says there is a certain logic to letting investigative clinical sites use one system, their existing EHR, to gather trial data. After all, that system is used on a daily basis. EDC applications, meanwhile, can churn away behind the scenes. “There are limits to how user-friendly you can make an EDC system. My thought is, don’t make EDC better,” he says. “Have the EDC system in the background, serving the forms.”

Patient Locators

Rogers says that the sheer number of working EHR systems is a challenge for the EDC world, given that a trial with 100 sites might have just as many EHR systems. Since many EHR systems were never designed to be regulated by the FDA, working out each connection will take time and dollars. “Linking to every EHR system is not going to happen in a reasonable time frame,” Rogers says flatly.

What to do? Rogers would invert the process, and have sponsors first identify sites with an EHR system that will readily connect with a chosen EDC system. “You figure out ahead of time which sites work,” he explains. “It is a little bit of a mind shift.”

As an example, the Nextrials system connects with the Epic EHR, which is used in the Kaiser health care system in California. Nextrials can also tie in with the EHR from Greenway Medical, which is building a network of clinicians who want to work in clinical trials.

In one project, Rogers saw a sponsor use an EHR system to find 2,000 prospective patients. Those sorts of numbers could well inspire other sponsors to force their EDC vendors to handle a manageable, limited number of EHR-EDC connections.

Having said that, Rogers is also a realist. He concedes that the energy behind the industry's campaign to connect with EHRs is dissipating. The effort may need a new evangelist in the mold of Landon Bain, an expert in clinical trial systems who we interviewed two years ago in this story.

Missing Catalyst?

“We lost our highly visible advocate,” Rogers says. (Bain, for the record, is alive and well but putting more time into other projects.) “It’s fallen to a more distributed advocacy, which is less effective.”

“The sites would absolutely love this,” Rogers says of EHR-EDC integration. “It’s the sponsor companies that are sitting back. I find that frustrating. This is ready for pilots. This is where EDC was ten years ago. People should be doing studies with EHR. Pharma companies have not stepped up.”

To be fair, there is an industry task force on the EHR integration question; we wrote about that effort here. Yet while the sponsor community can vocalize support for EHR and clinical investigators, that rhetoric has never been translated into anything tangible or specific. For now, until investigators insist on using their EHR systems and not EDC systems, linkages between the two worlds are an undated to-do-list item for the industry's senior management—an abstract and diffuse initiative that floats far above the heads of the vast majority of clinical trial professionals working on individual studies.

In the end, sponsors may not have any latitude to change EDC systems to make them significantly different for sites. That could lead to additional frustration. “At what point,” Rogers asks, “is the pain level going to build where the sponsors react to it?” Good question. It will be a pity if the pharmaceutical industry sits on the sidelines during the medical world’s next infrastructure push.