Digital Data, the Semantic Web, and Research

The positives of "going digital" are becoming more and more apparent for clinical research.
Aug 01, 2011
By Applied Clinical Trials Editors


Wayne R. Kubick
My newspaper didn't arrive this morning, so I had to view it on my iPad. As a result, I read it much more quickly, since it was easier to focus only on what I found truly interesting. The print version has been wasting away over the past year anyway, a mere shadow of its former self, denuded of most of the ads that used to comprise much of the printed bulk. This week's printed Time Magazine was a tad more than a pamphlet, though it appears much more substantial in the iPad app, which doesn't readily betray how thin the printed content would be.

We've been paying our bills online for some time now, though a number of our creditors still insist on sending us a paper invoice. I can't remember the last time I saw someone use a leather-bound day-timer either—unless it included a pocket for their smartphone. Then there are those bulky yellow pages books—which we threw right into the recycling last time since it's so much easier to look up phone numbers on Google.

My employer has an automated app for just about every administrative business process from training, to performance reviews, to expense reports. In fact, expense reports are pretty much the only things that still involve paper—for receipts, which I need to scan. I much prefer getting e-receipts sent right to my e-mail address, since they save me part of that effort.

Then there's my toxic wasteland of a desk. Whenever I search for anything on my computer, odds are I'll find what I want. But I can't tell you how many scraps of paper on my desk I've lost. I have a friend whose desk is always clean. Every time he gets a scrap of paper, he either moves it to disk or just chucks it. I've never searched through his computer, but his office is as pristine as an operating room table.

Now, let's segue to clinical research. Thanks to HITECH and other global initiatives, more and more physicians are implementing electronic healthcare record systems, and entering patient data as well as prescriptions directly into the system. Lab tests are conducted by devices, with reports output electronically. Regulatory-relevant documents are almost always created on a computer, and submitted to regulators in pdf and xml electronic formats. Yet CRF data is still typically first recorded on some sort of paper source document before being entered into a system. So why exactly do we still feel a need to use so much paper in clinical research?

Paper's more secure, some say. Well, except in the rubble of an unexpected disaster, or when you just lose it. And what about those disturbingly confidential patient lab reports that are somehow mistakenly sent to my home fax several times a week?

Paper's better for audits, others feel. Yet how difficult is it to edit a document and print out as many variations of it as you need to address various tiny issues? Even before the days of image enhancement tools, a touch of Wite-out and a copy machine were able to do wonders to tweak a paper document.

Paper's necessary to meet regulatory requirements, many persist in believing. But 21 CFR 11 is over a decade old, and ICH e6 Guidelines for Good Clinical Practice don't include a single reference to paper—though there are some 40 references to "records" which might be electronic or not.

So does source data and regulated information really have to be on paper? Or does it just have to be able to meet some of the same requirements as paper documents in a credible fashion? In other words, can we reproduce the digital version of such information on demand for review, and can we verify who authored it, when, and that it wasn't changed—without a paper crutch?

To find paper, we need to index and file it. But a physical piece of paper can only be filed in one place at a time, whereas a digital piece of information can be linked in many ways to many different catalogs, or even concepts. Digital information can also be broken down to items, elements, and things that can be linked with many other things.


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