Making Electronic Data Capture successful
By Paul Bleicher
Chairman and Chief Scientific Officer, Phase Forward Incorporated
Have you thought about why it has taken so long to make EDC (Electronic Data Capture) successful? EDC has been with us for 15 years, from its original quirky home-built solutions to the stable Internet platforms provided by some vendors today. Despite the apparent benefits of EDC, the method of managing clinical studies has been stubbornly resistant to change. Currently, fewer than 5% of the clinical studies use EDC. By contrast, many other paper processes have been replaced with an electronic equivalent. Insurance companies, for example, directly enter data into a computer before giving you a quote.
There are three emerging primary themes that impact the adoption of this new technology. These themes address the trial management process, the architecture of the system, and whether the technology is pushed onto—or pulled by its users.
It's a process, not just technology
EDC implementation is often seen as a technology challenge. In reality, it is an opportunity to transition an outdated process to an efficient, real-time, transactional one. Typically, the EDC systems of the past were inflexible, imposing difficult processes on users. Today, some EDC systems do not impose a rigid workflow, allowing an optimal blend of process and technology. Choosing a system that allows process flexibility is essential, allowing a smooth adoption process for EDC.
With a flexible EDC system, a study team can start conservatively by following existing standard operating procedures (SOPs). By the second or third study the team can redesign the process once they have piloted the changed process and understand its benefits. This is a classic innovation adoption model. Until recently, the bad experiences of many pharmaceutical companies discouraged them from following up with a second study with EDC where the benefits of the learning curve would really kick in.
Architecture of the system
Historically, EDC solutions required dedicated computers at each clinical study site. In the absence of the Internet, there was no other way to use complex EDC software. Descendants of these off-line solutions are still with us, providing the ability to use local software to produce reasonable performance and attractive graphics when Internet access is unavailable. Off-line solutions require large overhead for validation, support and maintenance at the clinical site because each clinical user site has local data and software that must be carefully protected to maintain data integrity and security. It is all too easy for data to be corrupted, damaged, maliciously changed or lost when it is located on a local site computer. In addition, off-line solutions come with a burden of procurement, tracking of assets, and shipment delays.
Off-line solutions can work reasonably well for one or two small studies, but they require armies of people to support medium or large-scale studies. The Internet gives the opportunity for centrally served "on-line" EDC. On-line solutions are maximally scalable, a factor that is often invisible in the small EDC pilot studies to date. Hybrid solutions purport to offer on-line scalability with off-line performance, but, unfortunately, they also have all the problems of the off-line solutions.
The users—push or pull
Solutions imposed on people are rarely as successful as solutions they choose. Many pharmaceutical companies have central EDC groups that recognize the technical value of EDC and are given a corporate mandate to choose studies. However, if EDC becomes a corporate push rather than a study-team pull, the team members will inevitably feel less ownership. Study teams are expert in delivering successful paper-based studies. EDC inevitably changes critical study set-up processes, introduces activities that the team members are not familiar with, and changes the nature of the relationship with clinical site staff. A corporate "push" can be seen as a threat to their success and something they feel they cannot control. In such a situation the imposed change is much less likely to succeed. On the other hand, study teams that elect to make such a change are, by contrast, more likely to own the process. They will make it work.
Conclusion
Careful selection of an EDC system should include consideration of the anticipated process. Next, the on-line or off-line connectivity issues will determine the level of overhead and ease of use. Finally, the study team must be involved early in the technology adoption to assure that the technology is successfully deployed. For more information, contact Paul Bleicher at paul.bleicher@phaseforward.com.
About the author
Paul Bleicher, MD, PhD, is the founder, chairman, and chief scientific officer of Phase Forward Incorporated, the pioneer in proven e-process solutions for accelerating global pharmaceutical development.
Source: Phase Forward Incorporated
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