Inertia, Poor Training Can Undermine EDC Efforts

Drug and device companies risk losing out on the competitive and regulatory advantages of electronic data capture (EDC) by failing to address their own corporate cultures, skimming over training efforts and failing to set clear goals before attempting to implement a program, experts told PIR last week.

"Many companies have made the mistake of spending a lot of money on EDC software and hardware, and then dropped the ball when it comes to training," said Gary Tyson, vice president at Campbell Alliance, a management consulting firm specializing in pharmaceutical and biotech companies.

While training represents a commitment of time and money, Tyson acknowledged, it is critical to provide meaningful training that goes beyond showing employees how the basic software works. Instead, firms should provide training on how employees' roles will change before they begin to use the system, he said.

Setting aggressive goals is also critical, Tyson said. Many of the people who will ultimately be using the EDC system are likely comfortable with how they are operating already, he noted. "Clear goals help those people to think more aggressively about how they can use the software" to do a better job, he said. Examples of goals include:

We will select a single EDC vendor by July 2006; We will conduct X percent of clinical trials in EDC by the end of 2006; We will use EDC to reduce cycle time from last subject/last visit to database lock from 12 weeks and four weeks; and We will increase monitor capacity by 10 percent through use of EDC.

To succeed with EDC implementation, grappling with the inertia at many FDA-regulated life sciences companies is crucial, agreed Peter Gray, CEO of Icon, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

"Adoption of new technology [like EDC] that requires substantial process change in any organization is usually limited by the ability of the organization to absorb change, rather than the merit of the technology itself," said Gray. "Successful EDC implementation requires process changes that impact roles and, as such, established organizations [like drug and device firms] will tend to be slow adopters."

Gray said that even though recent advances in systems and internet reliability and speed are accelerating the move from paper to EDC, the main hurdle is still "overcoming organizational inertia."

In general, biotechs are adopting EDC faster than traditional pharmaceutical companies, mainly because they are smaller and can adapt easier to change, Gray said. And while pharmaceutical companies may themselves suffer from inertia, physician sites participating in trials also have to adapt their processes to facilitate EDC, he pointed out. "It is therefore not surprising that adoption has been modest until now, and faster uptake still faces considerable challenges," Gray said.

Successful firms will rethink the way they function by conducting a wholesale review of their current operating processes, Tyson said. They will think about new approaches to data management and things such as the relationship between monitoring and clinical trial data management.

EDC provides some benefits to virtually any healthcare player, but Gray said it should be most attractive to drug companies engaged in complex, difficult-to-execute studies that are prone to investigator error such as oncology. "Having an electronic case reporting form helps to ensure correct protocol flow and compliance," he said. Other beneficiaries include "virtual companies [because] they can reap the benefit of immediate access to data even though the studies are being executed via third parties" such as contract research organizations, he said. -- Michael Causey