EDC Myths and Misconceptions
By Michael Harte

Much has been made of the statistics published on the percentage of clinical trials that are run electronically. Depending on the source of the data, this statistic currently stands somewhere between five and ten percent- a very low adoption rate given the relative age of the technology. After all, Electronic Data Capture (EDC) is not a new technology by any means.

One of the most influential factors contributing to this minimal adoption rate is the prevalence of myths surrounding the use of EDC. Like most myths, these originated out of some small element of truth, but many have long since ceased to be credible. This is perhaps most true about the myth of paper.

This first myth is that the clinical trial paper process works, so people prefer to use it. The facts from a recent Forrester study (Web Clinical Trials Break Through, July 2001) prove that this is simply not the case. Of the people surveyed for this study that had tried EDC, only 15% acknowledged a moderate or strong preference for using paper-based trials. Over 60% of this same group demonstrated a strong or moderate preference for EDC. In other words, once they try EDC, they like it.

This myth probably originated from aphoristic thinking along the lines of "If it ain't broke, don't fix it." The reality is that EDC is not a repair technology, but a replacement technology. Much like telephone service largely replaced the need for telegraphs, so too does EDC replace the need for paper. Paper isn't "broke," but there is a better alternative that exists and clinical professionals realize this.

The second myth is that EDC alienates doctors and nurses because it is a computer and web-based technology. Forrester actually reported that doctor investigators are open to on-site data entry because faster query resolution means shorter CRA visits. These CRA visits currently disrupt the normal workflow of an office environment. By eliminating those, doctors have more time for patients or for themselves. Because the study sponsor typically pays for the data entry done by the nurses, it also isn't a financial burden for the doctor.

The learning curve associated with EDC data entry can be measured in hours, not days. An online training program-like the ones offered by some Monitorforhire.com partners-gets both the monitor and the sites up to speed quickly. Most EDC software, like the products etrials makes, have very intuitive onscreen forms that make data entry a snap. The truth is, anyone who can understand the convoluted paper process will have no problem learning the comparatively simple EDC methods. In fact, they will be amazed by the efficiency gains.

The last myth is that patient data can't travel safely over the Internet. This is patently false. Millions of secure transactions take place on the Internet every day. Certainly, there are horror stories about security breaches that you hear periodically; these are the fodder for ongoing myths about the privacy of Internet data. But the truth is, there are some relatively simple steps you can take to prevent these breaches.

Look for EDC software that encrypts data before and after transmission. This way it is not only protected while in the "ether" of the Internet, but is also protected while residing on the central server (the machine that collects and stores all the trial data). Furthermore, make certain your EDC provider has a daily backup plan that includes off-site storage of backup tapes on a regular basis. Finally, implement a policy in your study that requires unique per user identifications and passwords.

Though there are a number of shadowy myths surrounding the use of Electronic Data Capture in clinical trials, the truth shines a brilliant light on this fact: EDC has many unique advantages over paper. Choose a data management vendor who can arm you with facts to disprove myths and one who is willing to evaluate your readiness for EDC.

Michael Harte is a pharmaceutical industry veteran and an executive in charge of sales at etrials, Inc. Check out www.etrials.com for more information.