Feb 15, 2006 | On a Tuesday evening in the fall of 1977, viewers of ABC’s popular television sitcom Happy Days watched as Arthur Fonzarelli, also known as The Fonz, wearing his trademark leather jacket and swim trunks, water-skied over a shark tank. That episode convinced many viewers that, in an attempt to stem a decline in ratings, the producers of the show had strayed from a core principle of the show. Sadly, the Fonz, who had always been the coolest of the cool, now wasn’t cool at all. Since then the term “jumping the shark” has become a metaphor for something that was once good but has gone irreversibly bad.
Over the last several years, electronic data capture (EDC) has been very cool. Everybody seems to be deploying or planning to pilot EDC trials. IDC’s latest Leading Indicators in Life Science IT Spending Survey demonstrated that companies are aggressively moving from pilot EDC implementations to enterprisewide adoption strategies. Thirty-five percent of respondents to that study stated they are currently using EDC in their clinical trials. However, that number jumps to 58 percent when respondents were asked what percentage of trials they expect to be using EDC within 12 months.
But as data management teams begin to deploy EDC in their clinical trials, “cool” gives way to the cool reality that IT investments have to produce real results. Vendors tout reductions in time-to-market and lower clinical trial costs. But to some of their customers it might seem that EDC vendors may not be living up to their end of the bargain. Wasn’t EDC supposed to change everything? Sure, after deploying EDC, visit data are available 80 percent faster, the number of queries has been reduced by 40 percent, and the database can be locked in less than half the time it took using paper. But isn’t EDC supposed to do more? Isn’t EDC supposed to shorten the time-to-market and reduce the cost of the trial? Where are those benefits, and, by the way, where is my leather jacket?
Maybe it’s not so much that EDC hasn’t delivered, as it is our desire to seek out magic bullets. Often executives are too quick to look past the incremental benefits of getting better data faster, as this in itself changes almost nothing. Real benefits arise when that data can become the information on which managers can act, and EDC is only the first step in that process. If you ascribe to the premise that “garbage-in equals garbage-out,” then EDC solves a basic set of problems. Problems which, left unresolved, prohibit many things from happening.
Until EDC tools were available, a good data manager was often judged by how quickly he or she could generate a query. You see, data managers know far too well that the time between an error in data entry and the time it takes to generate a query against it is a key performance indicator. As a former colleague of mine is fond of saying, “Queries have a shelf life shorter than milk. The last thing anyone wants to open is a three-month-old query.”
Data management teams should prepare for major changes in 2006. They must learn to shift their focus away from delivering tactical services to becoming strategic partners in the drug development process. EDC is an indispensable tool in making that a reality. So give EDC credit for what it is, a fantastic solution for electronically capturing clinical data. If data managers are looking to shorten time-to-market or reduce the cost of a trial simply by implementing EDC without the necessary process changes, they may just end up as shark bait.
Chris Connor is life science senior research analyst at IDC Health Industry Insights. E-mail: firstname.lastname@example.org.