Some people get dragged to a movie—only to discover they love it. That appears to be what happened to Marina Nillni, Dana-Farber/Harvard Cancer Center’s corporate team leader for clinical trials information systems. Dana-Farber picked Phase Forward’s InForm software as its electronic data capture (EDC) solution, but delayed using it for the largest, gnarliest trial at the academic medical center.

“I am a cautious project manager,” she says. “We held off a little bit because as with any new technology, there is a learning curve. We said, ‘let’s put a few good trials under our belt and then tackle acute lymphoblastic leukemia (ALL).’ ”

The trial is funded by the National Cancer Institute (NCI) and slated to recruit 500 children over five years. It’s the largest currently under way at Dana-Farber, and its complexities had been part of the reason that the hospital selected Phase Forward in the first place. Says Nillni: “This is one of the studies that drove the decisions to do electronic data capture. Ever since we purchased InForm, there was pressure to put ALL online.”

Indeed, Dana-Farber’s ALL study is a beast that would test clinical operations teams in industry: there are numerous remote sites, 36 unique case report forms were developed, 49 unique edit checks were programmed, and the case report forms had 147 unique items or questions. All told, each patient in the study needs to complete 8 visits and a total of 50 forms, which (with a few standard questions) works out to 77,500 data points in the trial.

Things are going swimmingly, with 114 children enrolled so far. “I was personally surprised,” Nillni reports. “I thought we were going to have issues of training and computer support. It went very smoothly. None of our fears came true. It’s been amazingly smooth. It speaks well of the product and our team.”

For budgetary reasons, Dana-Farber handles most of the technology work of EDC, designing the case report forms and hosting the application on its own servers. Says Nillni: “We only tap into Phase Forward for infrastructure issues. We’ve been flying solo since we launched our first study.”

As a large academic medical center, with 900 faculty-scientists, Dana-Farber could have accessed RDC, the Oracle Clinical tool for EDC. It also could have used open source tools from the NCI. Those didn’t pass muster, Nillni said. “We decided to spend some money to have something that would work well for us,” she says. “What we saw in InForm was huge flexibility in the design tools and a great architecture.”

The need for EDC in the academic setting is far from clear. The expense of the technology, not to mention the attendant change in work process or the raggedy IT found in even fancy medical centers would all seem to argue against it. The twist here is fascinating: Dana-Farber likes EDC for the same reasons people in the corporate world do. Once the initial preparation is done, getting the job done is easier.

“This is not a cheap undertaking,” Nillni concedes. But she sounds like an unexpectedly happy customer, partly because of the support from Phase Forward, and partly because of its software’s ability to support Dana-Farber’s scientific agenda. “The business driver is not the mega blockbuster drug,” she says of her employer, which in 2006 is working on 133 investigator-initiated trials in 13 therapeutic areas. “It’s all about scientific advancement and publishing papers.”

Even there, Phase Forward is helping. Just a month or two after getting Phase Forward’s software, she says, one team of Dana-Farber physicians were able to run a standard InForm report and present their findings at the American Society of Clinical Oncology (ASCO) meeting. Says Nillni: “From a principal investigator perspective, that’s the biggest thing. The data is there. They can go into InForm, run a report and the data is there. They can publish it.” In a world in which the data were recorded on paper, the same data would probably have had to wait until the following year’s conference.

The rollout of EDC throughout other Dana-Farber trials will be done gradually, but it’s clear that Nillni prefers the electronic approach. “When we do the studies on paper, the cleaning of the data is mind-boggling,” she says. “Managing the whole paper process with remote sites is cumbersome and inefficient. The query management is by email. The cleaning of the data could take months. The whole process could take months. Can you imagine five years of paper forms?”

The ALL study had already started using paper forms, but that transition to electronic data entry posed no difficulties. “They really have an architecture that is robust and scalable and really lends itself to remote data capture,” Nillni says of Phase Forward. “Oncology studies are very complex. Everything we have wanted to do, we have been able to do.”

This article is related to another story that includes comments from Phase Forward about Dana-Farber and the use of its technology in academic settings.