Dec. 2006 / Jan. 2007 | With 175 organizations as members, the robust and vibrant Clinical Data Interchange Standards Consortium (CDISC) is a tribute to president Becky Kush’s vision for nonproprietary pharmaceutical data standards—and to her uncanny ability to attract both generals and savvy ground troops for the fight. The opportunity to do something for the industry as a whole seems to invigorate and inspire just about everyone associated with CDISC.
Even former naysayers are now onboard. The largest vendors in the industry, many of whom doubted the importance of standards, are now registered by CDISC. The organization has also just begun certifying vendors, which is an additional level of evaluation that costs between $2,000 and $12,000, to assess adherence to the Operational Data Model (ODM).
Kush says sponsors of clinical trials, large and small, are starting to see the wisdom in standards. “They’ve seen the value for providing standard formats for FDA,” Kush says. “They’re starting to see that for a given trial, over half the benefit comes if you start the process up front.”
That growing support was plain to see at CDISC’s annual meeting last September in Bethesda, Maryland, where 200 attendees gathered in an almost gleeful atmosphere. The individual CDISC standards are being slowly refined and combined with each other. The FDA intimated that CDISC standards will eventually become official policy, while work to assimilate CDISC standards with those of hospitals is ongoing. The CDISC work is especially powerful in analyzing drug safety issues: It facilitates analysis across trials and throughout a class of compounds.
“Some companies can go look at their database and find they don’t have to do post-marketing studies they thought they would have to do,” says Kush. “If you have the data, you can say, ‘Oh, we don’t have to do a study.’ Or they can do better designs.”
In short, data standards are, well, increasingly standard. Kush’s next goal is to continue the work of contract research organizations that had sought to standardize each element in a case report form. If this highly ambitious effort succeeds, “weight” on a clinical trial form would mean the same thing across the industry. PhRMA is participating, as is NIH, and AMIA. Says Kush: “It will help vendors. It will help FDA. It will help sponsors. FDA sees it as a path to higher-quality data.”
Even so, Kush concedes that the unique history and landscape of data at each life science customer can complicate the transition from a customized approach to standards. “We are trying to figure out the best way to convey a business case,” says Kush. “The savings rate up front on a trial is 80 percent. But if we start extrapolating that into dollars, people say, ‘That’s not the way it is at my company.’ So we are going to give people an Excel spreadsheet so you can plug in your own numbers.”
Email Mark Uehling.
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