Wayne R. Kubick
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In a lot of ways, clinical research seemed a whole lot easier in the old days. Data was collected on paper CRFs and keyed
into a Clinical Data Management System (CDMS) for cleaning and analysis. Sure it was primitive, awkward, and slow but it was
also familiar, generally accepted, and predictable. At most, you might have to load an external lab file, and most of the
data you needed would be in one place where you could run your queries, review your listings, and fire off a complete set
of SAS datasets to the statisticians for final analysis.
Of course, memories tend to gloss over some of the grimmer aspects of past realities. Paper also causes lots of other problems
such as quality, data reusability, and lack of timeliness. Yet, it seems like those double data entry clerks were pretty fast,
efficient, and cost effective at the time.
I also recall giving a talk at RAPS back in those days, describing my experiences as a global road warrior. In those days
my 007-like attaché included a profusion of communication and work devices. I had a laptop and attachments, with a series
of international electrical and modem telephone connectors. I used a Palm Pilot to manage my calendar and contacts, and a
clunky cell phone and a sleek pager to keep in constant voice contact. I carried a walkman to help distract my brain from
the pain of distance running using my digital chronograph to keep track of my training times. Add in spare batteries and power
supplies and I was ready for the road. Obviously, this preceded my inevitable back surgery, which resulted from hauling all
that gear around the globe.
Today, my kids pretty much manage to do everything they need with just a mobile phone (and a laptop for more complex and visual
computing purposes). They don't even bother with a wristwatch anymore. Not only do their smart phones have most of the computing
applications they need, it also has their data: contacts, URLs, photos, music—basically all they care about on a day-to-day
basis. Being able to use one multipurpose device that covers your essential daily activities and information needs—that's
what we mean by convergence. Disconnected processes
Now convergence of clinical applications didn't seem so essential in the old days, because everyone had their own distinct
tasks and the tools they themselves needed for their particular job. Sure there were those who tried to create a Swiss army
knife out of a portable computing device, but these were found to be deficient in too many respects and excelled at nothing.
Meanwhile, clinical study data rolled along the assembly line without much cross-utilization by different functions. Back
then a CDMS served as an adequate data repository for clinical trials, when the primary purpose was to enter and process data
for a regulatory submission. Once a study was locked, we'd just package up the individual SAS datasets and send them over
to Statistics for reporting.
Oh, maybe the clinical people used some sort of Clinical Trials Management System too, which, more often than not, came down
to a collection of spreadsheets and documents. And then there were those safety folks obsessing over the Serious Adverse Event
reports—they inevitably used their own system as well. But that was okay—each group minded their own business most of the
time.
Like most other computer systems of that era, none of these applications talked together very well. Once in awhile, someone
would buy an integrated suite of products with high-gloss marketing literature claiming to bring everything together in a
seamless package, but it turned out these didn't talk to each other much better either. This didn't surprise anyone—and as
a result didn't quite sweep the market either—which was tolerable as long as there was a good enough tool for each specific
job.
But after years of psycho-dependency on my smart phone, I tend to travel a little lighter these days. And I've developed a
keen appreciation for a smaller set of multipurpose tools that can access most of the information I need via the Internet.
I suspect a lot of others feel similarly and wonder why clinical applications haven't kept pace with the rest of technology.
Because times have changed, different types of data are coming in faster in much greater volume in many different ways, and
the old study CDMS's aren't necessarily up to the task anymore (especially as the world finally edges over the tipping point
to EDC).
