Info & Opinion
May 18, 2013
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
With the always-brief Boston summer safely behind us, and winter coats on standby, it’s time for another cherished seasonal exercise. We’re poring over the Drug Information Association (DIA) program, trying to choose a few good sessions among hundreds of intriguing presentations at next week’s annual meeting.
In the course of this exercise, we had a minor epiphany. We have now formally suspended a longstanding effort to figure out what “eclinical” means. Whew. The word “eclinical” has turned up in the business pages of the newspapers, with the likely merger of Parexel and ClinPhone. It is scattered throughout the program of the DIA meeting this year, as it has for the past few.
“Eclinical” doesn’t just meant “electronic data capture.” It doesn’t mean anything. It’s a nebulous, fuzzy catch-all term that in some cases represents serious organizational transformation, and in others represents little more than empty words. For a more nuanced discussion of what “eclinical” should mean, readers may want to look at this recent ClinPage article describing a presentation by Ron Waife.
Defining Our Terms
Another term, fortunately, does retain some meaning. Judging from our preliminary inspection of it, the words “electronic data” are easy to find in the DIA program this year. They are clear, sharp, simple. In a jargon-loving industry, it’s a bit easier for us to get our reporter brain around “electronic data,” and there is no question that topic is a prominent theme or an undercurrent in many tracks at DIA.
What’s changed? What’s different? It’s a very gradual and imperceptible change, triggered not by the success of the commercial electronic data capture suppliers (who have supported this website from the start, bless ‘em.) Those firms did set the ball in motion. But a lot of other forces and companies have done heavy lifting to move it down the field.
There is a new sense of the inevitability of the use of electronic data across areas of domain expertise and geography, in sponsors and companies supporting clinical trials. Instead of interest or reluctant acceptance of one particular technology (EDC, patient diaries, adaptive trials, pharmacovigilance, document management, trial management systems) there is a sense of how much sense it makes to use more than one system. To connect them.
As a wheel transfers its load from one spoke to the next, the world of electronic clinical data should smoothly move from lab to contract research organization, from site to sponsor to regulator, from one system to another, from preclinical to the post-marketing environment.
One term that is starting to count is “interoperable.” We’re looking for a few sessions on it at DIA.It’s high time for a term that cannot be as easily finessed and glossed over as “eclinical.”
Burn That Paper
Here’s a pop quiz around the I-word. Try asking your colleagues or vendors: If we invest in this new program, if we hire this company, if we launch this trial, will its data be interoperable with every other system (trial/vendor/stakeholder) we already have? How easy will it be to view this data and pipe it into another system?
If you don’t know the answer to the question, and colleagues don’t know, odds are that the CDISC (clinical data interchange standards consortium) partisans in your organization may be able to tell you. Someone should get to the bottom of the interoperability of any new element or project.
We do understand that aiming for interoperable systems sets the bar pretty high. Some companies in this industry may never lose the pounds, do the training, to get over that bar. But for others that do, there will be competitive advantages and operational efficiencies that matter.
The economic forces rocking the industry, not to mention the heightened scrutiny from the public, require greater transparency and fluidity of operation with every passing month. Paper does not supply transparency. Paper does not make for fluid operations.
Looking At The River
If you have an EDC system, it’s a bit daffy to try to manage your data in a spreadsheet. Isn’t it? If your patients are recording their data into Windows mobile phones, does it really make sense to have paper queries for the rest of the study? Given that a study is being randomized on the web, shouldn’t monitoring visits be scheduled accordingly? Do you want to manage payments for 200 investigators using a legal pad?
Many providers of technologies and services are at work on all this. No one has the market cornered. The best firms are enabling more of the industry’s clinical data to be electronic. We have a visual image of a stream of pieces of paper, actual sheets of it. It’s a paper river. The sheets are flowing slowly around rocks and boulders and other familiar obstacles.
Some distance away, much farther down that river, it is increasing in speed and force. There we see less and less paper—and more and more electronic bits. The lower part of the river seems a bit healthier than the upper part, to be frank—and more likely to produce the medical insights that drive this industry.