EDC Conquering the Pharma Industry
Historical and practical barriers to using electronic data capture (EDC) in clinical trials are falling worldwide, experts say. “It’s a very exciting time in our industry,” said Ed Ikeguchi, chief medical officer at Medidata Solutions. “It’s gratifying that the industry is starting to come around and people are starting to realize that there is a return on their investment.”
While resistance to leaving paper behind is fading all the time, Ikeguchi said, “in order to work, [EDC] has to provide advantages for everyone who touches it — monitors, data managers and statisticians. Physicians are benefiting because it’s a controlled data collection environment with audit trails.”
No Contest Against Paper Trials
Errors are frequent when using paper records under the rushed conditions of clinical trials, Ikeguchi explained, and this can make it necessary to reenter the data later, or in some cases to even call patients back. Workflow is also a frequent problem with paper records, he said.
“In a paper environment, almost no data cleaning is done until you enter the information from paper into a computer, which causes workload ‘spikes.’ You work like mad sorting through the data at the end of the study,” Ikeguchi said, and EDC helps prevent these problems.
At the same time, EDC helps clinical trial monitors “see in real time which sites are more effective,” Ikeguchi said. EDC also helps data managers distribute their activities more evenly during the course of the trial, speeds up interim statistical analysis of results, and brings about “database lock” at the end of the trial much more quickly — producing a 5–10 page statistical summary rather than reams of paper.
The first EDC solution was developed about 25 years ago. Ikeguchi recalled that various commercial EDC products became available for clinical trials when he was working as a urologist at Columbia University Hospital in New York in the early 1990s. Initially, he said, researchers were enthusiastic about the prospect of eliminating paper and improving audit trails.
“But it was a tremendous flop,” he said. “When we were exposed to these systems, we found that they were tremendously cumbersome to use if you were a doctor or nurse at the site.” Multiple EDC systems were often required, each with its own computer or laptop, and the hospital simply ran out of room. “It become logistically unfeasible,” said Ikeguchi, “and in the mid-1990s, we took a step back to paper.”
The situation changed again in 1997 with the passage of FDA’s 21 CFR Part 11, which gave EDC a regulatory push in the U.S. “It was only a start of this [technological] uptake, but it was key,” said Ikeguchi. It took significant advances in the technology to finally persuade pharma companies of the utility of EDC.
Coming of Age
“The coming of age of true web-based thin-client technology and email made it more feasible to adopt [EDC] at the site,” said Ikeguchi. (Thin-client technology allows the user to run certain programs on his or her own terminal as if they were running on the higher-powered server.) Secure socket layer (SSL) technology made internet browser-based EDC safe, he added. Thus “EDC became a lot more cost-effective and scalable, since it is possible to leverage technology that is already available at the hospital or clinic.”
These developments brought out the potential of the technology, and starting in the late 1990s more and more pharma manufacturers began using it in clinical trials. When he joined Medidata Solutions in 1999, “we had almost 100 percent ASP — application service provider — deals,” Ikeguchi said. This changed over time as “we realized we could develop the back end — the database. We realized we were doing the same thing as in any CDMS [clinical data management system] — setting up data tables, doing edit checks, coding. Once that started to click, EDC became more strategic — EDC and CDMS can now be done in one fell swoop.”
More than 50 percent of the pharma companies that have adopted EDC over the past year have done so at the enterprise level, a strategic change that reorganizes the way they process data, said Ikeguchi. “Pharmaceutical sponsors are looking seriously and thinking more strategically about EDC. It’s not just conceptual; the true success stories are well publicized these days.”
Companies are using EDC “as a competitive tool against those still using paper trials; and the hard metrics say they are saving hundreds of millions of dollars,” said Ikeguchi, who has given presentations on EDC recently in Tokyo and Paris, as Japanese and European pharma firms also get on board with EDC.
Further developments lie in store, and “the next big step is “an interface with electronic health records systems, so that it will be integrated with hospital systems,” Ikeguchi said. “Data will be entered once on a patient chart and then entered into a study. But that’s a few years away.”
Here the FDA may once again play a helpful role. The agency has encouraged using electronic patient recorded outcomes (ePROs) because “[they were] shown to generate more accurate data in studies without the need to enroll as many subjects,” said Ikeguchi. “It’s been a very positive influence on our market.”
“It’s a conservative marketplace, but we’re past that,” said Ikeguchi. “People are following the leaders well past the middle of the curve. It’s not a risk issue but a matter of survival.” — Martin Gidron