Wyeth Aims for Conducting 100 Percent Of Its Trials Using EDC by Next Year

Wyeth has achieved a remarkably rapid conversion from paper records to a mostly electronic data capture (EDC) system in its clinical trials, a transformation the company hopes to complete by 2007.

In 2004, only 5 percent of Wyeth’s new clinical trials used EDC, according to Ira Spector, vice president for clinical development operations, who told PIR that Wyeth runs “a couple hundred trials” at a time. The figure was up to 30 percent by 2005, and the current rate for 2006 has jumped to more than 80 percent. Spector hopes to nudge that figure up to 90 percent before the year is out, and to achieve 100 percent EDC integration next year.

“It’s a very steep implementation curve for all clinical trials,” said Spector. The explanation for this rapid change is simple. “We’ve been watching the [study] sites for several years to see their uptake of internet technology. Our RDC [remote data capture] system uses internet technology and requires no special hardware. About two years ago, the rate of availability of internet technology reached the point where we could do the conversion,” Spector said.

Strictly enforced corporate policy keeps that implementation curve rising. Wyeth is currently allowing studies to be done on paper if they were originally planned that way, or if they are follow-up studies to previous clinical trials conducted using paper forms. In the latter case, sticking to paper forms is necessary to avoid unnecessarily introducing bias into the experiment, Spector said.

In any case, Wyeth management has introduced a “deviation” rule, whereby “if you are not using EDC, you need senior management approval,” Spector said.

A Cornucopia of Benefits

Wyeth is enjoying multiple benefits by making EDC a universal standard for all of its clinical trials, Spector said. One positive result is reduced queries. “In an electronic world, you assure better quality of data by filtering and screening at the entry level, which eliminates a significant level of errors,” Spector said.

There are many other benefits. Digital data are easier to process than data from paper forms, which must be scanned and digitized, with a correspondingly greater chance of errors being introduced, Spector said. Page flow — the movement of actual paper case report forms — is made smoother by EDC, since the only “pages” being transferred are electronic.

Money savings are not to be ignored. Wyeth is projecting a $5 million reduction in data management costs by the end of 2006, thanks to its EDC effort. Data management costs currently account for about 12 percent of Wyeth’s total trials budget.

Yet another benefit is instant communication between research sites, which can be located in any of the 60-odd countries where Wyeth operates. The company’s EDC system quickly establishes protocols and randomizes drug assignments, Spector said.

Swifter Approvals Possible

EDC may not directly speed FDA approval of a drug, but it could provide an indirect benefit, since data enter the database faster and are likely to be reviewed faster, Spector said.

“The FDA has been asking for more electronic clinical submissions,” Spector said. Wyeth prepared its first esubmission for the FDA from paper trial records, but EDC is simplifying the process, he added.

“Wyeth was the first to submit all-electronic data, [and] we believe there is a benefit there in terms of FDA review of the data,” Spector noted. The agency has given Wyeth “excellent feedback” on its esubmissions, he added.

In addition, the hyperlinking capability in esubmissions can help satisfy FDA officials’ questions more quickly than searching through data submitted on paper, noted Gerald Burr, a media relations specialist for Wyeth. While a reviewer is reading the cover letter, if it mentions adverse events or patient profiles, he or she can click on the link to get the information, he added.

Spector agreed, adding that the ability to hyperlink into a higher-level document is also improved. If the FDA reviewer can access the information he or she needs more quickly, the review process, as a whole, is speeded up, allowing new drugs to potentially reach the market sooner. — Martin Gidron