Dana Farber/Harvard Cancer Center (DF/HCC) is undertaking its first sizeable investigator-initiated trial (IIT) using Phase Forward's InForm electronic data capture (EDC) product. So far, it's going surprisingly smooth, says Marina Nillni, EDC implementation program manager. "We went live November 15, 2006 and I have heard nothing about it. I'm the technical support contact person, so that means things are working."
The Phase III pediatric acute lymphoblastic leukemia (ALL) study, which started on paper in January 2005, will ultimately involve more than 500 patients at nine centers in Canada, Puerto Rico, and the U.S. Currently, about 159 patients are enrolled at eight sites with an average of two clinical research coordinators (CRCs) per site doing data entry, says Nillni. "The concern, initially, was that we would have trouble training and supporting remote sites and that has not been an issue."
DF/HCC is a consortium of five Harvard-affiliated institutions created with funding from the National Cancer Institute and is the nation's largest oncology center. In 2005, it standardized on InForm for all its IITs after a rigorous evaluation process that measured 12 EDC vendors against 173 weighted criteria, says Nillni. About 60 IITs were initiated in 2006, accounting for about 25 percent of all new oncology studies done by DF/HCC. Approximately 230 IITs are ongoing at any time.
After signing the contract with Phase Forward, DF/HCC spent the next eight months on set-up and training. Between October 2005 and November 2006, DF/HCC launched 12 small phase II gastrointestinal and breast cancer studies using InForm to "get familiar with the product," says Nillni. Each study accrued between 30 and 60 patients. The folks in IT and data management were completely unfamiliar with InForm.
The initial studies went "very well," says Nillni. Data already produced on paper for the ALL study was back loaded into InForm, a process that required about 40 hours. "CRCs really liked [InForm] and data managers were very happy." According to one CRC, a GI investigator was so impressed with InForm's real-time reporting capabilities that he decided to use EDC for all of his future studies. With paper, he was waiting four weeks to get study data.
Phase Forward was selected as EDC vendor over three other finalists: Oracle Clinical, Medidata, and Velos. At the time, each had key weaknesses that took it out of the running, says Nillni. "With Oracle Clinical, the remote data capture product was not very functional." Further, the product wasn't Web-based. "We would have had to purchase laptops for all users and install a heavy client into each machine." Customer service was also a downside. That Oracle Clinical works with both paper and EDC was irrelevant to DF/HCC. "We don't do hybrid trials."
With Medidata Rave, the problems were an infrastructure based on Microsoft Sequel Server and "out of reach" pricing. Velos, like Oracle Clinical, had an immature EDC product. It was also a small firm and "we wanted to work with a more secure, more established company." The other contenders were DataLabs, Datatrack, Enmed, eRT, etrials, FirstGeneticTrust, LifeTree Technology, and Percipenz.
Development of the selection criteria was a nine-month team effort involving information systems, data management, a biostatistics representative, and clinical teams, says Nillni. Among the 31 "must haves" were a library of data items, eCRF version tracking, centralized system upgrades, and the ability to import data from multiple external lab systems.
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