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Clinical Speakers Enjoy Industry Acceptance

By Mark D. Uehling

May 12, 2006 | For the first time at the Bio-IT World Conference, the clinical speakers did not wring their hands about whether their tools would be accepted by the industry. This year, it was a question of how quickly technology would be used to expedite trials and raise the quality of the data therein.

TRACK: E-Clinical Trials & ResearchAs one example, etrials’ chief financial officer Jim Clark rattled off impressive numbers that were not greeted with any thunderous applause or spontaneous weeping. 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 two-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 corporate culture squelches public discussion of the use of e-clinical technology, Lammers was a fount of information. Serono has now completed 38 clinical trials using electronic data capture (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 getting to database lock faster,” Lammers said. He also detailed the company’s goals for transitioning to 80 percent of its trials done using EDC, which 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, CIO 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, 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 customers want EDC bundled with other technology solutions and services. 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 striking 36 percent compound annual growth rate. 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 reporting 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.

EDC-EHR — Not So Fast
Paul Bleicher, founder of Phase Forward, took a skeptical view of the hypothesized convergence of clinical trial computer systems and generic hospital and physician computer systems — the merging of EDC and electronic health records (EHRs).

Bleicher conceded that EDC-EHR convergence is a laudable objective, but he doubts it is going to happen. “The path to achieving this is oversimplified by everybody in the process,” Bleicher said. “Without EDC and EHR vendors coming to together to make this work, it’s going to take 15 to 20 years.”

From Bleicher’s perspective, there is no business case for any EHR vendor to add EDC features and functions. Clinical trials are not sufficiently lucrative 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.

Another obstacle will be the hospitals and physicians themselves. Could sharing terminology and data schemas help? Bleicher insisted he is not opposed to data standards, but a far deeper synchronization and harmonization must occur within and across companies and even international boundaries. That convergence will be a decades-long proposition if it ever materializes at all.

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