Study taps web software in novel clinical and genetic research of infants

In a push to advance the use of genetics in personalized care for tots, Inova Translational Medicine Institute has mounted a study to correlate the genetics of young children with developmental issues. With plans to include 2,500 families in the observational study, the nonprofit has commissioned Medidata Solutions ($MDSO) and Digital Infuzion to provide a web portal and cloud-based technology for recording patient data.

Data from the three-year study could predict the relationship between genetics and developmental issues, shedding light on new pathways for treatment and preventive health measures. The study follows infants during the first 1,000 days of life beginning in the womb, with plans to collect genetic profiles of each child and his or her mother and father. Dr. John Niederhuber, a former chief of the National Cancer Institute and now CEO of Inova Translational Medicine Institute, said that the study needs "the appropriate technology in order to conduct this unique investigation of genetics and infant health."

Inova's study is another example of how investigators are using advances in information technology to tap real-world data for studies. GlaxoSmithKline ($GSK), Pfizer ($PFE) and other pharma heavyweights hunger for real-world findings--which include data from outside of traditional randomized, controlled clinical trials--to gain insights about health outcomes and the safety and efficacy of new treatments on the market. Widely accessible genomic data and analytical software add a whole new dimension to the potential impact of real-world studies, giving investigators the tools to link genetic profiles with what they observe in the clinic and analyze the results.

It certainly won't hurt Medidata to be named as a tech provider in Inova's study as the major clinical tech outfit seeks more Big Pharma business. The software package for the study combines Medidata's Rave software for electronic data capture (EDC) and Digital Infuzion's N of 1 platform for physicians and other investigators to gather data in the clinic. Parents will tap its web portal to complete surveys about every six months and receive information and updates over the course of the three-year study. Genomic sequencing data is expected to be accessible to investigators in the Amazon Cloud.

Medidata President Glen de Vries

"By combining clinical data with individual gene sequencing, Inova is truly pushing the boundaries of medical research to identify exciting new treatments and prevention pathways," said Glen de Vries, president of Medidata, in a statement. "We have continually evolved the Medidata platform and its integrations with forward-thinking partners, such as Digital Infuzion, to create the innovations that enable novel research like this."

- here's the release

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