this huge transition to electronic data capture, which Pharma has made over the course of a decade, is finally over… Or not.

“Yes, we’re using it.” This is today’s universal answer to the question of EDC. And rare is the company who won’t claim to be “moving toward 100%.” At the same time, we’re told that the technologists have moved beyond EDC and that EMR integration is the next big thing. And so, this huge transition to electronic data capture, which Pharma has made over the course of a decade, is finally over… Or not.

The progress and the success in using EDC is real and the EDC/EMR of the future is exciting, but you (and your management) should know that numerous, significant benefits of EDC remain untapped by many, if not all, sponsors. These benefits have the potential to provide sponsors with continued process improvement and substantial return on investment (ROI), long before any new, technical advances in data collection are ready for large-scale use. Let’s look at five things you can still do with EDC to reap those benefits and make something good even better.

1. Ease the start-up pain

The length and complexity of EDC start-up timelines may be the most universal problem still encountered with this technology. It also provides the primary ammunition for today’s few remaining EDC skeptics. When experienced users are asked for the number one improvement they wish for, the answer will almost always contain a reference to time. “Too long,” “too slow,” and “too often” are the painful watchwords of the EDC startup experience.

The cause of this common complaint may surprise you, for it has little to do with technology. In a retrospective analysis of any start-up timeline, technical programming will not be the task that consumed the calendar. Rather, the time will have gone to study teams as they debate about what to program. Inefficient, ineffectual decision-making within clinical teams, masked in the past by paper-based processes, is landing this issue smack on the critical path of trials using EDC. Fixing this problem may finally convince those remaining skeptics and reduce the stress level of your study teams.

2. Do real data cleaning

Some of you may remember the Jetsons cartoon, where George’s job in the world of the future was reduced to sitting at a desk all day, pressing an unlabeled button over and over. George’s “value-added” may be the best analogy to today’s data-cleaning methods, methods that remain strangely unaltered by EDC. Huge infrastructures, developed to handle the mundane errors that paper CRFs produce, still remain in place, with legions of people checking and rechecking things that EDC edits have already prevented or caught.

What is the error rate of your data with EDC? That is, how many data points are ever changed from the site’s original entry (after those entries have passed EDC’s auto-checks)? You may be surprised how few errors remain to be treated. Sponsors who measure this have found that 95%, 97%, and even 99% of their data remain unchanged, even after the herculean efforts of the cleaning legions.

Reallocating those resources in more thoughtful ways can increase data quality even further by allowing closer looks at the whole forest (where important safety and efficacy trends await discovery), rather than staring harder at the trees. This reallocation can also provide opportunities for efficiency gains in an age where “doing more with less” is a frequent mandate.

3. Make monitoring more useful

The field-monitor role should be a crucial component of a trial’s success, both in the terms of the study’s conduct and in the preservation of its integrity. Yet this important role is often reduced, even in a world full of EDC, to the status of an on-site (double-)checker. EDC can change this model by enabling visibility of and interaction with the clinical data by monitors when they are away from the site.

The potential for monitors using EDC in this way away from the site is enormous. (The Monitor devoted an entire article to this in its June 2007 issue). The ability to see the data, to see what has changed, to see what has not yet been entered (though it should have been), to dialog with the site through manual queries about specific data points; all of these open new vistas of value-added tasks and responsibilities that can turn the “double-checker” into a contributing study-team member. Optimal use of these capabilities can provide insights into protocol issues, EDC design flaws and improved site performance. And all of this is available without using up one minute of that valuable on-site time with the investigator.

4. Find the efficiencies

EDC enables, really for the first time, the recording and time-stamping of diverse clinical activities across multiple roles. Sponsors can now track numerous metrics that indicate how well processes are working and how well people are performing: How soon is the site entering data? How quickly are monitors reviewing data? Are freezing and locking activities keeping up with the volume of entered data, or are you looking at the famous bolus of cleaning just prior to data lock? How about the efficiency of your editing efforts? Do your edits actually fire? Which ones?

It may surprise you to learn that much of that frantic edit-programming during start-up didn’t yield a lot. One sponsor found that 70% of their several hundred programmed edits never fired at all, while only a couple of edits accounted for 25% of firings and fifty accounted for 90%. All of this information is available, with almost a trivial amount of effort, out of an EDC tool that tracks and measures an enormous number of clinical trial process variables.

5. Lock all of it, not some of it

The now ubiquitous, fast database-lock times achieved by so many sponsors are encouraging, yet these times are often skewed by the failure to address all the data. Many celebrations of five-day locks ought to be accompanied by a footnote that says “EDC only, CDMS and SAS still to come.” This disconnect fails, in an odd way, to create any more value for the business than a paper trial.

The close-out of a trial deserves as much process improvement as the start-up. Work on those improvements, to be sure, will take you away from EDC and into the realm of external-vendors: their data flows, their contractual deadlines and their execution. But the chief benefit of EDC is easily frittered away by these very elements at the very end of all your efforts.

Sponsors who lock everything and lock it quickly do so by creating a last patient, last visit (LPLV) scenario where all previous data, regardless of source, has already been dealt with. For them, achieving final lock requires only handling the last set of eCRFs, the last set of analyzed blood-draw data, etc. These trivial amounts of data are easily coped with and incorporated into the final data set.

The good can still get better

Few sponsors enjoy today all the benefits mentioned here, not even those who think they are already “100%.” These five areas are the remaining fruit that can still provide further value to clinical development through the use of EDC. As we keep an eye on the (still distant) future of EDC/EMR, these additional benefits from EDC are available now and offer to sponsors both process improvement and substantial ROI.