It would be hard to find a firm handling more electrocardiogram (ECG) data than ERT. The company handles 9 million ECG data points annually.
Not long ago, the firm decided to do something about industry-standard ECG data error rates in the neighborhood of 80-90 percent. That's no typo.
The typical error rates reflect the difficulties that all life science companies encounter—grossly antiquated methods of hand transcribing heart data to a piece of paper or an electronic system.
The resolution of even minor gaffes is costly, running perhaps $10 to $35 per error. On a human level, the correction can involve a few emails, phone calls or even a personal visit to a clinical site. ERT wondered if the ECG error rate could be slashed by 85 percent.
To find out, the Philadelphia-based firm (with 650 employees and $141 million in 2010 revenues) sat down and tried to rethink everything. For starters, ERT codeveloped (with Mortara) a new ECG collection device, the Eli-PC. (There's an image of it here.) Then ERT whipped up software to connect the Eli-PC to a clinical trial database. The project to reinvent the ECG took $22 million in all.
John Blakeley, ERT's executive VP and chief commercial officer, says that the Eli-PC device permits a tighter, less error-prone way to record the heart's electrical activity. "It is no longer a dumb data device," he says. "It connects over the internet to a clinical database. It effectively allows data cleaning to take place at the point in time the data is keyed."
In real time, the person collecting the ECG data may see a textual warning of a discrepancy, or differently colored boxes that indicate data that are not conforming to the expectations of the system. Many errors are never created in the first place and thus do not need to be managed later.
Blakeley says ERT is trying to bring the advantages of electronic data capture (EDC) to cardiac safety data systems. As with other types of dirty data in the pre-EDC era, the research community may not be aware of all the costs that accompany the old way of gathering large quantities of ECGs.
Since launching the system, ERT has been testing it with six unnamed sponsors. Four are large household names; two are smaller or mid-sized concerns. Between them, the six companies have been using the package of ECG services and technologies at more than 1,000 clinical trial sites. In many cases, there is heavy daily usage. "There is some scale to what I'm saying," says Blakeley. "It's incredibly promising."
ERT's internal analysis shows that the collective ECG error rate has dropped to 13 percent. That's impressive. In an industry that typically logs incremental improvement, it's a quantum leap in data quality.
The new ECG services and tools are being offered to all ERT customers. The system is appropriate for a large portion of drug safety projects, Blakeley says, though not trials requiring triplicate ECGs or studies needing data on QT interval prolongation.
Beyond the economic savings from cleaner data, Blakeley feels the system should accelerate the clinical development process, allowing data analysis and regulatory filings to be completed far more quickly. With the right system, he says, clean cardiac data can be locked as quickly as any other kind, in weeks—not months.
Most regulators and outsiders to the research process, Blakeley concedes, have no idea how much labor is involved in dealing with the high error rates of the traditional paper-based ECG management. "It's an area that has only laterally been looked at from an efficiency standpoint," he says.
But in a new climate of financial pressure, some sponsors are probing into the reasons for high costs. "There is a sea change," says Blakeley. "There is a difference between price and cost. Historically, they threw money at the problem. They've had the money to throw." No more.
Aiming For Consistency
The Eli-PC enables sponsors to have a centralized interpretation of the ECG. Centralization reduces the variability of 1,000 far-flung internists, oncologists or family practitioners interpreting their own ECGs, each with some idiosyncratic quirk that mucks up the data. For years, Blakeley says, the industry has valiantly attempted to centralize ECGs, but never with ERT's unifying aspects of a single instrument and centralized approach.
He regards the shift as transformative if the technology can purge some of the variability from traditional ECGs. He wonders aloud if the ill-starred Vioxx would have made it to the market if its cardiac profile had been assessed in a rigorous, consistent manner.
"You start to be able to drive consistency into the process," Blakeley says. "And consistency drives efficiency. You're going to see that more and more. We see a change in the marketplace. One of the changes gathering pace is the need for sponsors to do things a) more cost-effectively and b) better, i.e. better quality."
He doesn't have hard facts yet, but believes his system may cost only two-thirds as much as traditional, legacy ECGs transcribed in the standard way.
At the corporate level, he says, ERT is nudging customers to sign contracts that allow it to handle ECGs and other safety-related matters exclusively. More work leads to more efficiency, he says. A deeper relationship (modeled on the mega-deals that Covance is developing with its clients) leads to lower costs for sponsors and higher-quality data for the scientific process.
In short, Blakeley sees an end to the familiar paradigm of sponsors majestically dictating their needs to subservient vendors and CROs.
The key is a strategic bond. Says Blakeley: "Strategic to me means we get 80 percent or more of an organization's business in the area we specialize in. There is an agreement that we look not just at price but cost. That is very important. There is a mutual agreement to help each other. It is not a one-way street. Those days, for us, are coming to an end."
It sounds like ERT doesn't flatly turn down isolated projects, but tries to help customers transition to more strategic relationships. The question now is whether the industry at large will transition to cleaner, more standardized ECGs voluntarily or wait for some new controversy that makes their usage obligatory.d9A2t49mkex