It’s hard to believe, but the world of clinical trials management was still mostly paper-based as late as the early 2000s, thanks to heavy regulation and an extremely conservative user base. “There were databases, once data got from the research center to the organization managing it, but they had no exposure to the outside world, and the time lag between data collection and availability in electronic form could be months,” says Robert Lyons. “If there were data problems, they could also take months to resolve.”
Robert Lyons has been one of the key players involved in turning this situation around, working with the Clinical Data Interchange Standards Consortium (CDISC) to put together an operational XML data model standard for data interchange in clinical trials. The standard is now under review by the FDA.
As co-founder and CTO of Nextrials, Lyons is also the architect for Nextrials Prism, a complete software suite for designing and managing clinical trials based on XML standards -- and one of the first systems to meld clinical trial management with electronic data capture in a single package. “It’s not just a Web front end,” says Lyons. “It’s a complete soup-to-nuts suite for designing studies, collecting the data, preparing the data for submission to the FDA, managing inventory associated with study drugs, and subject enrollment and randomization.”
Lyons is also an open source devotee. “We used exclusively open source tools to build our software and deploy it, including PostgreSQL for our back-end database, the Apache Web server as the app server, and a lot of PERL, Java, and Flex, which is now open source.” The benefits of Lyons’ new suite include deriving more value from trial data in real time, better trial safety and accuracy, faster drug and medical device time to market, and lower drug development costs. “It’s all about getting more research done so that people can be healthier,” says Lyons.