I ask him about Merck's September 2004 withdrawal of Vioxx. Says Helton: "There are several COX-2 inhibitors. [The scientific community] will benefit in being able to look at the cumulative safety and clinical benefit of these drugs if the FDA, with common data standards, can look across those drugs because all the data are in the same format. They've not been able to do that historically. We've never been able to look across pharmacologic classes or across therapeutic areas and gain insight into safety and efficacy. We're never going to get the knowledge we can extract from information unless we have standards. Vioxx represents an example of that."
Helton continues: "By having data in common standards for the first time, we'll be able to extract out the knowledge that we want, to make these decisions and provide better public health. Nobody has been able to do this yet. But there is no doubt about it. Having common data standards will greatly contribute to preventing these events in the future."
Standards, of course, are like nails - wonderful inventions that require some other tool, say a hammer, to maximize their utility. So SAS is also developing software that couples the company's statistical know-how with what it believes its user community will soon demand to analyze CDISC data. Assero Limited, Lincoln Technologies, and other firms are developing these tools. And so is SAS. SAS has a new ODM Viewer, an XML Libname engine, and the XML Mapper. These are utilities that will be used to manipulate CDISC data.
As a CDISC board member, Helton is more gung-ho about CDISC than some clinical technology vendors, which tend to cryptically allude to possible implementations of the CDISC standards. "The most exciting thing," says Helton, "is that FDA is going to be putting out another guidance for the adoption of the ADaM model." That CDISC model, as you can read here, governs statistical datasets.
Helton himself will be one of the speakers in the e-Clinical Trials & Research conference program at the 2005 Bio-IT World Conference + Expo, May 17-19, and with any luck will inspire other vendors to take an equally forward-looking approach to standards generally and CDISC in particular.