Chicken, Egg, or Just Plain Chicken?

There is much discussion now about the uptake or technology adoption curve of electronic data capture (EDC) and other advanced information technologies for clinical research. Is the uptake of EDC in fact “slow”, as many analysts contend (which begs the question of what should be judged “slow” in the first place)? Or is it instead unbalanced, with some companies leaping ahead and others staying on the sidelines? There are several confounding variables: for instance, use and commitment are not the same thing. We clearly do not know enough about the thoughts and behaviors of the total universe of clinical IT decision-makers to answer why one company is farther along than another. Yet sponsors and vendors alike would love to know the answer.

This situation strikes me as a series of “chicken and egg” arguments. Which comes first:

The technology or the user?

Use or commitment?

Proof of success or experimentation?

There is no question that today’s information technology for clinical research is superior to that of five or ten years ago. And yet companies were adopting innovative technologies for their time fifteen years ago – like remote data entry or third-party clinical data management systems. What made those companies (or individuals) risk-takers? Clearly, today’s exciting technologies, and rapid technology change, are stimulating creative thought among both sponsors and vendors, and without the technology (the Internet being an obvious example), many applications or functions could not exist. On the other hand, notable clinical research software such as Clintrial¢â and Impact¢â were highly influenced in their development by key early adopters. Indeed the involvement of these sponsors was essential to their early success. So which comes first, the technology or the user?

In today’s EDC market, there is a big difference between use and commitment. There are companies who are well-known users of EDC in relatively high volume, yet they are uncertain as to their vendor, technology or strategy choices. At the same time, there are companies who are quite vocal, even at the executive level, about their commitment to EDC, but whose volume of EDC use is still very modest. Can a sponsor ever really increase the use of a technology significantly without widespread management commitment? Can commitment lead to widespread use without someone taking on the hard operational job of actually getting the software implemented? Which comes first?

And then there is the fundamental question of change itself – why and when do some people change behavior when that choice is new and unproven, and why do some people never change? In clinical research IT, we are grateful to those companies, or individual managers within them, who took on new technologies as an experiment, or as an expression of faith or optimism, or because of unusual in-depth knowledge, or because of a recognition that this was the first step on the right path.

Process change in clinical research is plagued, on the other hand, by those for whom no amount of “proof” will make them budge from the way they have always done work. How will the uptake of newer information technologies accelerate if too many companies wait for the proof of success? As we often say to clients, if you wait until someone else proves to you that new technology works, you’re already too far behind: not only has your competitor used the new technology successfully, they have started to learn how to use a new process successfully – a skill every company desperately needs to stay competitive in an increasingly difficult business climate.A recent survey we conducted among top 10 pharma in regards to the adoption of EDC bore out these chicken-and-egg conundrums. Here were ten companies all of similar size, in the same business, doing clinical trials according to the same regulations, in many of the same therapeutic areas and following the same basic principles of clinical research. And yet we found companies who have used some sort of EDC for years and some who still haven’t (and are proud of it). We found companies who have used many vendors and technologies but do not seem to be making progress in committing to EDC as a clinical research pillar. We found other companies whose executives have apparently set very aggressive goals for EDC penetration in total trials over the next 3-5 years, and yet these companies have barely begun the process of learning about EDC and its impact on the trials process.

The companies who refuse to change, or still want to wait before using innovative clinical research IT in the year 2002, strike us as those who are contemplating neither the chicken nor the egg, but rather are just plain chicken. We worry more about those companies with lots of commitment and not much use. Unless these companies get started with these new technologies, in an appropriately organized and well-planned implementation process, their executives will be sorely disappointed. Will these companies then conclude it was the technology’s problem all along, or will they recognize the failure of their implementation planning? On this answer hinges the acceleration of efficient clinical research. It never really matters whether it is the chicken or the egg; it’s the growth of the flock that counts.