Articles

Is EDC a Commodity? What About eClinical Systems?

By Timothy Pratt, PhD
Originally published at BioITWorld.com, March 2007

Let's start with defining a commodity. How about "an undifferentiated product good or service traded solely on its price" (Wikipedia, March 2007). Other definitions include concepts surrounding interchangeability and "sameness" - for example, electricity is a commodity: It is what it is, and pretty much the only difference is the price. Apples and oranges are commodities as distinct classes - but compared to each other, they're obviously not. A good working definition then might be, "an undifferentiated product of such similarity to the same product from different producers that the only difference is the price - all commodities in a class work equally well for a given application".

How does this pertain to electronic data capture (EDC)? Sponsors and clinical research organizations (CROs) alike often persist in attempting to treat it as an undifferentiated product - it's all the same, so any EDC will do for your trial, right? Curiously, these same proponents of "EDC as a commodity" are often the ones to vigorously defend, say, their biostats or case report form writing services, as "non-commodities" - they're better, smarter, longer tenure, etc. Not the same as Joe's CRO down the road. Don't judge just on price! For shame!

EDC vendors get pushed by some of their customers to produce requests for proposals and bid documents that enable some degree of cross-comparison - the famous apples to apples juxtaposition. Why? There's a perception of "sameness" - that each is as good as another, and it is all about price. Recently, at a conference on reverse auctions (RA), one panelist bemoaned the fact that her corporate masters were on her case for using the RA process to drive prices down for clinical services, but then applying other criteria to make the final call not based solely on price. What her managers were saying is, "It's all the same - price is all that matters", and of course that is the fundamental premise of reverse auctions. My colleague was trying to get around it, understanding fundamentally there is a difference between providers.

So is EDC a commodity? Is all EDC the same? The pithy answer is: Go ask someone who has used two or more systems, you'll soon find they vary widely! How? Let us count the ways:

  1. Capabilities: Some EDC products still can't process honoraria, manage investigational inventory, or even cope with conditional branching where only the questions the site needs to answer are displayed (reduces error rates);
  2. Price: Some vendors charge a fixed price to deliver what is needed, while others charge per data element or per edit check (predisposing to eliminating fields and programming to get costs down at the expense of outcomes);
  3. Service: Some systems require little to no downtime at all for most changes, whereas others require the system to go offline, sometimes for weeks, for the simplest changes;
  4. Fundamental characteristics: homogeneity vs. heterogeneity. Simply stated, is the system one contiguous entity capable of instantaneously making data available within the whole, or is it an "integrated" set of disparate systems that were never designed to talk to one another, and which do so only grudgingly at best?
  5. Configurability: Can the system meet your individual workflow needs, or is it an "out-of-the-box, one-size-fitsmost" product?
  6. Zero-client or fat-client: Can sites use generic PCs, or do they need a dedicated system or unique software that affects other programs - or only one type of browser (that they may not have or want)?
  7. Ease of use: Some EDC systems require little to no training, while others require you to go to their "university" to figure it out... there's lots more, but let's stop before it gets silly.

Do we find characteristics of undifferentiated sameness in popular EDC systems currently available? Even the simplest EDC system can be easily differentiated from its competitors on the criteria above. More sophisticated, cutting-edge EDC systems incorporate full-blown clinical data management system (CDMS) and most clinical trial management system (CTMS) functions as well. They're called eClinical solutions and belong in a class all their own - they vary even more dramatically from each other in characteristics and capabilities.

Will any EDC or eClinical solution do for your trial? Probably not - they're not all the same. Attempting to treat EDC or eClinical technology like a commodity is like trying to compare apples to oranges - the differences are obvious if you look. A superior approach is to focus on the results desired and find a system that meets your needs. A failed study or need for extra staff arising from technology limitations costs much more than a few percentage points off the price of a good EDC/eClinical solution.