Bio-IT World has sponsored a conference in Boston on life science technology since 2002. This year's e-clinical track at the Life Sciences Conference + Expo was once again aided by Ken Getz of Tufts University's Center for the Study of Drug Development and Becky Kush, president of the Clinical Data Interchange Standards Consortium (CDISC), who were the pivotal organizers of an outstanding track.

One speaker, etrials' Jim Clark, the company's chief financial officer, rattled off impressive numbers without being greeted with any thunderous applause or spontaneous weeping. That's yet another sign of electronic data capture (EDC) being taken for granted.

As an example, Clark said, his company had recently assisted on a trial in 15 countries with 7,600 patients and 613,000 case report forms. The etrials system had four servers supporting 168 different users with less than 2-second page turns. "All the data entry was completed in 28 days," Clark said.

It was equally impressive to listen to Serono's chief medical officer, Paul Lammers. The Swiss biotech is the world's third largest, after Amgen and Genentech. Unlike those two companies, where lawyers and corporate culture squelch public discussion of the use of e-clinical technology, Lammers was a fount of information. Serono has now completed 38 clinical trials using EDC, he said.

Time to database lock has been cut sharply, from 20 weeks in 2002 to 6.5 weeks in 2004. "EDC has truly helped us get to database lock faster," Lammers said. He also detailed the company's goals for transitioning to 80 percent of its trials to be done using electronic data capture (EDC). That 80 percent goal would be unattainable at many companies. It's all the more noteworthy when you consider Serono only signed up its EDC vendor in 2002. To hear Lammers tell it, there was no supplier with a global presence comparable to Phase Forward.

Uwe Trinks, chief information officer of Sentrx, a drug safety firm, was just as impassioned about the need for technology systems that talk to each other seamlessly. In part, he believes, that's because biomarkers will be more fully incorporated into all phases of clinical trials. Thus EDC and laboratory and safety systems will need to sync up. "We will have to build bridges between these systems," Trinks predicted.

Carol Rozwell, research vice president at Gartner, said her interviews with users of clinical trial technology are showing that customers want EDC bundled with other technology solutions and services. The percentage of trials using EDC, Gartner figures, is 25-30 percent. That's a pretty typical estimate. But Gartner goes further, projecting that by 2010, trials using paper will take 50 percent more time. Rozwell is currently working on a research project, with an online survey, about standards and why companies are (or aren't) using them. "Next year, if you're not doing CDISC, you're going to be asked why," Rozwell predicted.

The combination of standards and EDC, Rozwell believes, is one that could slice billions of dollars from the industry's investment in research. "We're definitely poised for very strong adoption moving forward," Rozwell noted. This does not mean that the vendor community is suddenly beloved. "There is still a perception that many of the vendor products are not robust enough," she added.

Another fascinating speaker was Jean Paty, senior VP of global operations at invivodata. "We're really seeing some focus and attention from the FDA on patient-reported outcomes," said Paty, referring to a new guidance document from the government. Paty estimated the e-diary niche could be a $2 billion market by 2008, with a 36 percent compound annual growth rate. Yowza.

Paty believes there is a new level of comfort among customers choosing patient diaries. Clients no longer wonder if the FDA will accept data from electronic patient diaries. The questions have changed, Paty said: "What technology is going to be best for us? Why you? Why this technology?"

In some cases, he said, the FDA is recommending electronic diaries to sponsors in the course of routine discussions about trial design. One such letter, Paty related, advised that a handheld diary be used, and that it have a reminder built-in to make sure patients fill it out as directed.

Paty joked that he had difficulty remembering what he had eaten for breakfast that morning, much less the meals a week earlier. "Asking people [to report] what they did over the last week does not provide the insight we need," Paty observed.

By contrast, he said, some of the patient compliance with electronic diaries is impressive. Relating a peer-reviewed article on incontinence published a few years ago, Paty said the protocol required patients to record bladder mishaps three times a day. Compliance was fabulous by paper standards. Even during the middle of the night, as the accidents occurred, about half of the patients recorded their experiences on handheld devices in real time. It's not incidental that the Palms were set up to be able to record an incontinence episode in just 10 seconds.

InfaCare Pharmaceutical, a four-year-old small pharma out of Philadelphia, is working on a drug for neonatal hyperbilirubinemia. InfaCare estimates that one newborn in twelve is at high risk of the condition, and one in four is at moderate risk.

Ben Levinson, consulting pharmaceutical physician for InfaCare, noted the company was on a limited budget, but still wanted to use electronic data capture (EDC). InfaCare used just half a dozen investigators, finding 800 neonatal patients.

To handle the data, InfaCare selected Target Health, a technologically adroit clinical research organization (CRO) in New York City. InfaCare's three trials (one still under way) have used paper source documents, but in general the whole operation has been internet-based. And it has gone smoothly. "We had one final interim report five weeks after the database was closed," Levinson said.

He was especially glad that Target Health involved programmers and data managers upstream of data collection earlier than some in the industry, even as the trial protocols were being designed. Levinson insisted that those data architects start thinking about the structure of the database early, while there was still time to optimize it. Elsewhere in the industry, he notes, that expertise is sought only after the trial is completed.

Levinson was also glad to see data from two different laboratories (an analytical lab and the usual hospital lab) automatically populate the same database. That facilitated trend analysis and patient-by-patient data review. "We had it all on one electronic case report form (eCRF)," Levinson said of the lab data.

As many readers know, there are differing approaches to compare paper trial documents to electronic data-a process called "source document verification" (SDV). Large pharmas tend to do SDV on all data, but cost-conscious companies tend to view such an approach as extravagant. InfaCare has been doing 100 percent SDV, but in the future may take a different tack. Target Health's software could allow it to pick and choose mission-critical fields. Said Levinson: "With paper, you have to do 100 percent source data verification because there are no electronic edit checks up front."

Using the same database, Target Health also supplied an email newsletter for investigators participating in the trial. That publication served up milestones and metrics, listed by a number assigned to each site. But the investigators knew each other. And the recruitment numbers encouraged a measure of friendly jostling among investigators. "They almost started to get in a little competition about how to keep up," Levinson noted about patient recruitment metrics. The newsletter was also a communication tool to track adverse events and serious adverse events. "Everybody could stay up to speed with something we found," said Levinson.

Levinson believes that the up-front work before the start of a study can significantly affect the quality of the data, and it's fair to say he's happy with the services provided by Target Health. He believes that smart CROs can figure out ways to optimize site productivity and the scientific insights expected from a trial.

But thinking about the medical ramifications of the mundane ingredients of EDC (drop-down menus, edit checks, and electronic CRFs) may not be something that traditional CROs are equipped to do. Said Levinson: "It is significant that the organization has the components necessary to provide not only technical support for the eCRF but medical and statistical support as well. The value of Target Health was that they provided the medical knowledge along with the data management capability to allow for optimal use of the eCRF to produce a quality database."

In previous articles about Target Health, this newsletter has noted how the company blurs the line between a CRO and a technology supplier. There's another wrinkle here. We'd love feedback from readers on this. But it's clear that for small sponsors across the industry, the right services partner and the right technology provider can result in a far more effective database design and clinical trial workflow. We're sure that's happening with many vendor-sponsor pairings. Still, the InfaCare-Target story in Boston was quite compelling.

After the show, we checked in with Jules Mitchell, Target Health's president. He related that InfaCare had signed up for a typical package of services. What, exactly, has Target Health done for InfaCare? "We have done web trials, biostatistics, data management, protocol writing, and regulatory affairs consulting," Mitchell said. "We have also assisted with their European partner. We provided guidance to InfaCare when they were on clinical hold, and interacted with one of their key investigators, a professor of pediatrics at Stanford University. As a result of that interaction, we are now collaborating with Stanford, under a government grant, to evaluate jaundice in newborns."

The combination of CRO and technology vendor and trial design assistance was new to us, we must confess. Not to Target Health. "The full drug development team must now collaborate prior to study start," Mitchell said. "Because the database, data management plan, and data entry screens need to be up and running before the study starts, there is an increased chance that the study will be well designed."

Paul Bleicher says clinical trials and healthcare IT will not get hitched soon

When it comes to Powerpoint presentations, there is a proven, well-validated technique. Predict something vaguely hopeful that will occur in the distant future. Then repeat your heartening theme using different phrases, industry buzzwords, and bullet points. After inserting one (1) federally mandated cartoon from The New Yorker magazine, you're done.

Paul Bleicher took a different approach at the 2006 Bio-IT World Life Sciences Conference + Expo in Boston. The founder of Phase Forward gave a reasoned, ardent description of something that, in his view, will not happen during your career. This cuts against the grain of the diffuse, rosy-hued tone of most Powerpoints since the dawn of Microsoft.

Specifically, Bleicher takes a skeptical view of the hypothesized convergence of clinical trial computer systems and generic hospital and physician computer systems. In the current patois, this is called the merging of electronic data capture (EDC) and electronic health records (EHR).

Your correspondent has been a happy passenger on the bandwagon articulating the inevitability of such a convergence. So we listened with considerable dread that our fond hopes of the engagement of the two technologies would be called off.

Bleicher's message was more nuanced. He is willing to concede that EDC-EHR convergence is a laudable objective. That it is inevitable. But in the world we now live in, Bleicher just doesn't think EDC-EHR convergence is going to happen. One wonders if Bleicher is worried that any momentum EDC may have-any newfound comfort that the industry has with such technology-could be lost if too many people start fretting about EDC-EHR integration.

"The path to achieving this is oversimplified by everybody in the process," Bleicher told the crowd in Boston. "It cannot be done without the EHR or EDC vendors. Without EDC and EHR vendors coming together to make this work, it's going to take 15 to 20 years."

Bleicher and longtime readers are probably aware of collaborations between EDC companies and EHR companies like GE and Siemens, which dwarf Phase Forward in size. In some cases, major EHR concerns like Allscripts are partnering with Bleicher's competitors. This has been happening for a while. The question is how significant such efforts are. Bleicher is unimpressed. "They are early, nonscalable attempts," he says of the pilot projects.

From Bleicher's perspective, there is no business case for any EHR vendor to add EDC features and functions. Clinical trials are not sufficiently attractive, in revenue terms, to justify their inclusion in an EHR software development budget or warrant potential disruption to installed, heavily customized EHR systems.

And future EHR systems, Bleicher believes, will need reconstructive surgery to manage source document verification and structured data in a 21 CFR Part 11-compliant manner. It's worth pondering how many EHR vendors could comprehend 21 CFR Part 11, let alone adapt complex, Vietnam War-era systems to embrace it.

Bleicher said that another obstacle will be the hospitals and physicians themselves. To be nice about this, neither doctors nor their employers are at the vanguard of using computers. In general, unless you're talking about billing systems, hospitals and physicians have hesitated to use IT. In most hospitals, as Bleicher noted, Cobol-based systems are the norm. The American medical system has borrowed the philosophy of Henry Ford. You can have any color you like on your computer monitor-as long as it's orange. You need an image on your screen? Call a radiologist.

So for perfectly predictable reasons, many nurses and doctors are not infatuated with EHR systems. One can only speculate how such systems will be welcomed after they have been adapted to include the serpentine and regulatory contortions of the clinical trial workflow. This is just one reporter's guess-Bleicher was polite on the point. But as with those bolts coming out of Frankenstein's head, we think it's unlikely that adding EDC to EHR systems will make either more attractive.

Could sharing terminology and data schemas help? Yes ... but. Bleicher flashed a slide about CDISC. Once again, he insisted, he is not opposed to data standards. His point is that far deeper synchronization and harmonization must occur within and between companies and across international boundaries. That convergence will be a decades-long proposition if it ever materializes at all.

Our preceding paragraphs have had a breezier, tone than Bleicher himself did on the podium in Boston. But for people who want lots of somber details about why EDC-EHR integration is a long way off, check out his article from the March 2006 issue of Applied Clinical Trials. For anyone who thinks the integration of EDC and EHR  will be a walk in the park, that article is a sobering read indeed.     

Editor's note: Phase Forward is having a good year. In the most notable win of 2006 so far, the company signed up Merck as an enterprise-wide EDC customer. In February, the company reported 2005 fourth quarter revenues increased 18 percent, to $24 million. Revenues for 2005 were up by the same percentage, hitting $87 million. And Phase Forward's new Clinical Trials Signal Detection system won the company's second consecutive "Best of Show" award at the Life Sciences Conference + Expo.