Honestly? The word has tormented us. We are talking about “eclinical.” The once-technical term is now routinely being referenced on calls with Wall Street analysts. Google has zillions of links to it. We finally decided to wrestle with it in our own way.

To facilitate a serious journalistic contemplation of “eclinical,” we purchased an 80 oz. (5 lb.) bucket of raw Nestle chocolate chip cookie dough from a warehouse chain. 

Fuel For Thought

A team of three burly men were summoned to carry the bucket to our car. Upon rolling it into the ClinPage executive rotunda, we located a spoon and began to think. Colleagues were nowhere to be seen. That was a week ago. It’s been a sugar blur since then.

Not to be critical, but Nestle should consider selling raw cookie dough in a larger, more economical size. Our bucket, after we did the math, appeared to contain merely 10,530 calories. What about family-sized drums with a 55-gallon capacity? With a wooden pallet to protect the concrete floor of your garage?

As we expected, the cookie dough fed our contemplative process, such as it is. One epiphany: many otherwise savvy people in the clinical trial world believe the first letter of “eclinical” should be lowercase, and that the second letter should be capitalized, in the style of Apple’s iPod.

No. Sloppy capitalization of “eclinical” is—sorry—ungrammatical. Wrong. We cannot vouch for Russian, Hebrew, or Urdu. But in English, the middle letters of words are not capitalized. Put random capital letters in the middle of your child’s name, and you may understand. It’s not correct.

Typo Patrol

If people began capitalizing ordinary letters in an arbitrary manner (especially in a capitalization-crazed pharmaceutical industry), the slope would be slippery indeed. eVery WorD MiGhT hAve eCCentric CAPitalizaTion.

Long story short? When we had consumed a pound or two of cookie dough? It may not be popular. But “eclinical,” no hyphen, is what is proper. We are still waiting for the opthamological research that validates our view that overusage of capital letters irritates the retina.

Definitional Clarity

Having said that, we acknowledge the growing popularity of “eclinical.” To back that up, we have renamed our website’s “suites” department “eclinical.” It has the same stories as before, as you can see here. Our explanation of the territory covered by each editorial department can be found here.

What’s driving usage of “eclinical”? Marketing, partly. Beyond that, the industry is moving toward an era in which paper-based data exists for more of its life, like ocean-based salmon, in an electronic sea. Then, when the salmon-data are ready to slip into oblivion or go to the FDA, they may tragically convert themselves back to paper, just like fish swimming back to die in the freshwater streams where they were born. The circle is unbroken.

Beyond the subtleties of grammar and capital letters, the cookie dough revealed deeper mysteries about what “eclinical” should mean or might mean.

Gold Standard

We recalled that Ron Waife, president of Waife & Associates, speaking at the 2008 BioIT World conference, had a valuable assessment of “eclinical,” summarized on this website a while back. Consider it definition #1.

In a nutshell, Waife’s definition is an ambitiously synchronized exercise that includes process change and technology adoption. If you need to steal a definition, Waife’s is an excellent candidate: it is sensible and sophisticated. (Whether anyone has ever built a Waifean “eclinical” system for a large sponsor organization is something we don’t know.)

Not So Fast

In less rigorous usage than Waife’s, however, “eclinical” can also be tossed about as a synonym for electronic data capture (EDC). Which is confusing and mock-heroic. That’s definition #2.

It’s not one we agree with. You can call a cat ... a cat. Or you can call the same animal ... a feline allergy-response induction mammal (FARIM). Our preference is “cat.” It’s shorter, sweeter. Similarly, people who mean “electronic data capture” should say that, not get fancy with “eclinical.” “Eclinical” and EDC are not synonymous. Not every EDC system is worthy of the “eclinical” label. Even today, many clinical technologies are designed to stand as islands.

Future Shock

Some people have a more confused sense of “eclinical.” For them, “eclinical” is a delusion—a Starship Enterprise-worthy fantasy in which antiquated paper-based processes and buggy systems suddenly work magically, just as Apple products sync up with each other. This is definition #3.

The notion that software in the clinical trial industry will ever snap together like Lego blocks is far-fetched. Our industry is decent. Unlike the thieves and hustlers on Wall Street, our industry makes a contribution to a healthy society. But even in 2009, our industry is paper-encrusted and locked into processes that would be familiar to Charles Dickens. So dreaming about “eclinical” as fairy dust is not serious.

Real Connections

Inside even flawed definitions of “eclinical,” however, is a seed of something more important. A kernel of insight.

In this sense, “eclinical” may transcend marketing gibberish. For if “eclinical” means “a process or software application that will easily connect with everything you already have,” if “eclinical” facilitates adherence to CDISC data standards, if “eclinical” systems can accelerate clinical trial data analysis or transfer, then the term may actually mean something.

Ideally, any common “eclinical” technology or process should be interoperable with any other such technology or process. This is definition #4. In the future, the degree of interoperability might be certified by a third party for additional credibility.

Interoperable, certified, “eclinical” systems could represent a significant advance. They would merit champagne and bragging rights. In that sense, “eclinical” is what every company with a serious interest in efficiency should be trying to build—this year, next year and the year after that. Make no mistake. Like eating five pounds of cookie dough, real “eclinical” may take a while.

Pure Emptiness

The only problem with any glorious, angels-humming definition of the word is that some sponsor organizations remain invested in odd company- or therapeutic area-specific ways of running trials. In those situations, it is a nonstarter. DOA. Or, as people without cookie dough might spell it, dOa. This empty definition of “eclinical” has been dead for years.

Much like “Web 2.0,” “eclinical” for these organizations is just another buzzword, yet another catchphrase. Someday these organizations will probably appoint VPs of eclinical or chief eclinical officers (CECOs). It will sound nice. But it won’t mean a thing.

Readers in the sponsor community who have already built an “eclinical” future are encouraged to call (857-233-0168 x104) or write .(JavaScript must be enabled to view this email address) and share more granular discussions of the topic with the clinical trial community. Our guidelines can be found here.

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