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Recalling Reston: EHR + EDC = ???

Asilomar is a code word. It was a kind of Woodstock for molecular biologists and the people who invested in their vision. To such folks, "Asilomar" refers not to a lovely California beach, but to a 1975 biotechnology gathering that proved seminal to everything that happened later.

For those interested in the information technology of clinical trials and health care, your Asilomar has just concluded.

The place: Reston, Virginia's Hyatt Regency. The dates: Nov. 14-16, 2005. The buzzword that clinical trial technology types will have to memorize is "EHR," or electronic health record. Only an old codger, it seems, still says "electronic medical record" or, for that matter, "remote data capture."

Bio-IT World will be publishing a report on eXl Pharma's "Merging EHR and EDC: Integrating Patient Information with Drug Development" in our next print issue. That's due in postal and electronic mailboxes in mid-January 2006.

Until then, it's important to note that while compact (with several dozen attendees), the meeting was electric, partly because of luminous guidance from moderators Michael Barrett (of Critical Mass Consulting) and Stan Kachnowski (of Columbia University). Both have been thinking about this stuff for years. They superbly guided a three-day conversation about whether two IT continents (for clinical trials and physicians/hospitals) could be coaxed to drift back together.

An unanticipated star of the meeting, Johnson & Johnson's Somesh Nigam, ironically, did not appear on the podium until the end. But before then he had provided so many erudite, sensible questions and comments that Barrett joked a satisfying conference could be organized just around Nigam's observations. True enough.

Most of those attending the Reston meeting seemed to assume that physician and hospital systems (some day, somehow) would be enabled to populate clinical trials with demographic data and more. In some cases, this will mean that EDC, heresy of heresies, will occur in hospitals and ordinary physician offices. In other cases, clinical trial management systems will have a role to play. Either way, the devil is in the details.

And the Reston meeting laid out details galore. A few early EHR+EDC efforts (by Allscripts and Siemens) are especially tantalizing. In the Allscripts project, a physician practice went into the black thanks to a three-fold increase in clinical trial revenue.

The great question, the Reston uber-mystery, is whether it will be a) attractive, b) legal and c) technologically possible for pharma to help pay for EHR adoption that coincidentally assists patient recruitment in clinical trials. That's the goal. So it was fascinating to hear Barbara Tardiff of Merck, a physician-MBA who has spent time at SAS and at Duke University.

Having worked inside Big Pharma for about a year, Tardiff has not yet been fully trained to utter the nebulous pleasantries of most of the industry. Instead, she says what she thinks. Clearly.

Once upon a time, Tardiff related, "I thought this was a technology problem. We had data streams from applications that didn't talk to each other."

Since then, her thinking has evolved. "I've become convinced that it is a fundamentally more complex problem," Tardiff said. "Fundamentally, the incentives are not aligned. The separation of clinical research and clinical practice—which is a technological separation and a mindset separation—creates a mindset that reinforces the separation. We have these elaborate parallel structures around information management that have been designed to optimize the goals of the independent worlds."

As a physician, it plainly frustrated Tardiff to not have broad pharmacoepidemiological or outcomes data at her fingertips when she was practicing medicine. That seems to be what nudged her career on a more informatically-oriented path.

Tardiff cited Apple's iPod as an example of an ostensibly mundane device that, lo and behold, has captivated consumers and given birth to a truly new industry of online music sales.

She speculated that some sort of personal electronic health record might set in motion similarly earth-rumbling events in pharma and clinical practice. "The U.S. has been pokey in adopting computer-based medical records," she said. "But you can see the prevalence in other parts of the world. There is starting to be evidence that uptake is accelerating."

IBM is providing EHRs for all employees, she noted. "Things are going to change," Tardiff said. "It's a matter of how." The loss of medical records after Hurricane Katrina, she mused, might later be recognized as comparable to the early work of Ralph Nader, which overturned conventional ideas of automobile safety.

After a recent bout with Lyme disease, Tardiff confessed, she went online to do a little research. In short order, she had assembled a sheaf of facts. "I was armed with more information than my poor physician had an opportunity to access," she said.

Tardiff wondered whether similarly empowered patients, armed with their own charts, may begin to transform both drug research and health care. Likewise, might physicians, insurers or governments, accessing new databases about similar drugs, make better decisions about what is included or excluded from formularies?

Of course, the reality is that just standardizing the terminology of drug safety is a long-procrastinated chore at most companies—much less across regions or nations. Which is why some at the Reston meeting doubted EHR companies would ever grasp the difficulty of collecting clean data in regulated clinical trials.

But others replied that the EDC industry, far from being central to the continued rotation of the planet, could fade into oblivion once massive EHR companies build small, validated trial tools and bolt them onto their existing applications.

Responding to doubters and cynics in the audience in Reston, Tardiff was clear-eyed but resolutely upbeat that convergence is coming and will benefit patients and society. "A lot can happen in 10 years," she said.

A decade ago, Tardiff noted, IBM did not have a website. "I don't think this is unachievable at all. This future vision is not parallel worlds. Medicines will compete on the basis of data from large databases. The 10-year future vision is really quite compelling, not just in terms of benefits to drug development, but to patient care."

Continuing in that vein, Tardiff said, one priority for technologists in both the EDC and EHR camps is clear: "Focusing our data collection on the end product. Not confusing the format with the function. The end product is not having a drug on the market. It's having health care quality."

Tardiff had a number of talking points for what life sciences organizations should do now. But one of them resonated more than the others: "There is a strong need to work across organizations. It's not technology. It's getting data sooner, it's having more data visibility."

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