Expert: Implement EDC One Step at a Time, But Do It Now

The pharmaceutical industry is facing a crisis because it has failed to evolve, but the answer is simple: electronic data capture.

“Clinical development takes so long because it costs too much and the current state of affairs can be likened to a disease,” Sylva Collins, a principal with FBC Consulting, told attendees of the Clinical Trials Congress in Orlando, Fla., Feb. 15.

Symptoms include paper case forms, query resolutions by phone, monitor visits, faxed serious adverse events (SAEs) and a lack of standardization.

Standards are the answer to solving this lack of efficiency, Collins said, adding that “the benefits are evident to anyone who uses electricity.” She indicated that standards are needed for data management, statistical analysis, SAE reporting and new drug applications (NDAs).

Modern IT tools can transform clinical trials in a number of ways, according to Collins. Site visits — which are the single highest cost to sponsors — can be optimized by using statistical sampling, saving a lot of time and travel, she said. “EDC eliminates 90 percent of the cost,” Collins said, adding that it also aids in monitoring primary investigator (PI) compliance with FDA regulations. Also, EDC enables firms to have acccess to meaningful metrics.

“Metrics must be timely and accurate. Inaccurate metrics are dangerous because collecting information is expensive,” Collins said. “You can’t control what you can’t measure.”

For devising meaningful metrics, software development should be a core competence for clinical investigators. This doesn’t mean they need to be programmers, but the responsibility for specifications must reside with the department that will use the software, Collins suggested.

Clinical research departments must be able to develop the tools they need to work faster and better, she said, and third-party vendors cannot possibly take poorly-prepared specifications and “yield a product that will result in better clinical operations.”

EDC Opens Doors to Best Practices

EDC allows industry’s best practices to be applied on a broader basis. For example, with EDC, databases can be locked within hours instead of weeks or months; SAEs can be reported electronically; and electronic NDAs and submissions speed the process considerably.

“Adaptive trial designs are possible only when the speed of data collection, analysis and decisionmaking is an order of magnitude faster than the duration of the trial,” Collins predicted. “Instead of doing adaptive design, we are talking about adaptive design,” she said.

So why is there so little action?

“EDC is not a goal [but] a means to be faster, better and cheaper … The hard part is the deployment,” said Collins.

Companies should take small steps toward introducing EDC, and realize that all large software projects will encounter difficulty. The larger and longer the project, the higher the likelihood of failure, Collins said. She suggests building and deploying smaller, more manageable systems.

“Waiting for a system that automates everything is the same as doing nothing,” and a company still clinging to obsolete processes needs to start somewhere, she said. “Don’t ask the users what they want … the problem is that companies are staffed and organized by the way they work now, not the way they will work.”

Organizations should ask themselves what their strategy goals are and how they plan to measure success. “Don’t chase technology,” she urged. “Know what you want and why you want to deploy a specific technology.” — Tamra Sami