VA Develops Portal Technology to the Clinical Trials Paradigm

What's on your wishlist for electronic clinical trials management software (eCTM)? Easy study set-up? Automated workflows? Electronic data capture (EDC) of study data? XML-based architecture? Web-based? Capable of handling the full clinical trial lifecycle? Since we're making wishes, let's wish for software that's scalable in both costs and capabilities. That means that users get just what they need and pay for just what they get. In other words, the technology and cost overhead are proportional to the user's needs. It is not beyond the reach of small medical research organizations and there is the functionality and capacity to support major clinial trials efforts. OK--no one's doing all this yet, let's call the wishlist a "business model" and pitch it to venture capitalists for funding, right? Well, first, take a look at what the U.S. Government's doing to support clinical trials that are ongoing in one of its healthcare enterprises. [Continue]

As reported in an article in BioIT World|Best Practices, the wishlist is reality. It's all been done and it's all been proven by a healthcare enterprise that's typically running more than 40 simultaneous clinical trials. That is, the U.S. Department of Veterans Affairs (VA) Cooperative Studies Program (CSP). A January 2005 report from the Medical Innovation Task Force of the U.S. Department of Health and Human Services (HHS) called for standardization of electronic clinical trials management and for consistency in clinical data across the clinical care and clinical research worlds. A VA medical informatics group found that no vendor offers an adequate proprietary solution to the challenge posed in the HHS report. Responding themselves, the group did find, though, that CDISC standards for clinical trials data and commercial, off-the-shelf (COTS) web portal technology along with other COTS technology such as Microsoft's InfoPath and Sharepoint Server provide a base of consortia-developed standards and commercial technology to rapidly and economically create a wishlist-compliant eCTM. Clinical trials are government regulated and so compliance with FDA regulations such as 21 CFR Part 11 was an important part of the eCTM development. VA's "COTS Plus" software development model complied with FDA requirements. The VA credits their eCTM system with a positive direct return-on-investment (ROI) from improved clinical trials management as well as with enhancing the operational efficiency of trials management for an indirect positive ROI.