City of Hope clinical researchers soon will have access to one of the most advanced electronic data capture (EDC) systems available, according to Joyce Niland, Ph.D., chair of the Department of Information Sciences. The technology marks a major upgrade to current systems.
City of Hope recently chose the Medidata Rave EDC system to manage clinical trials led by City of Hope investigators, as well as those involving City of Hope researchers but headed by clinical research cooperative groups such as Southwest Oncology Group.
|Gabriel Peterson, center, and Clinical Research Informatics Core staff can assist researchers with clinical trials data. (Photo by Darrin S. Joy)|
Clinical researchers can use the Medidata Rave EDC system to collect, manage and report data from their studies. New York City-based Medidata Solutions produces the system.
“City of Hope will be one of the first cancer centers to adopt the Medidata Rave EDC system,” said Gabriel Peterson, director of City of Hope’s Clinical Research Informatics Core (CRIC). The system is an industry-leading product used by biotechnology and pharmaceutical companies, he added.
City of Hope purchased the system late last year, and Peterson expects it to become available as a service to clinical researchers by the end of this month.
As clinical research associates enter data into the system, it will enable clinical researchers to look at data on patients participating in clinical trials — such as adverse events and tumor response to therapy — as data are collected. That will allow researchers to make adjustments to study protocols as needed. It also features built-in safeguards to keep data secure and ensure data errors are caught quickly and corrected, Peterson said.
The Medidata Rave technology meets federal regulations governing electronic information systems, providing a major upgrade to City of Hope’s clinical research informatics systems, according to Niland.
Niland, who holds the Edward and Estelle Alexander Chair in Information Sciences, led the charge to make City of Hope one of the first cancer centers in the U.S. to develop its own electronic clinical information system at a time when most research organizations relied on paper-based processes.
“As with any change like this, there will be a learning curve, but clinical researchers will find this system much more efficient, flexible and customizable,” she said.
Two pilot studies — a gene therapy study under Behnam Badie, M.D., director of City of Hope’s Brain Tumor Program, and a breast cancer study under Thehang Luu, M.D., assistant professor in the Department of Medical Oncology & Therapeutics Research — currently use the Medidata Rave EDC technology. More will follow as research faculty and staff become familiar with the system, and the clinical research informatics staff adjusts it to City of Hope researchers’ needs.
“The Medidata Rave EDC system is a key part of CRIC’s strategy to provide world-class informatics tools to investigators at City of Hope,” Peterson said. “We’ve instituted a number of changes and upgrades that we think will really help investigators with their studies.”
Aside from its work on the Medidata Rave EDC technology, CRIC offers customized electronic data capture using computer-scannable forms, decision support to develop custom reports of clinical research data and a full-time telephone help line to assist clinical researchers.
Clinical research staff interested in the Medidata Rave EDC system or other CRIC services may e-mail CRIC_help@coh.org or call ext. 3-CRIC (32742).